FDA Licensure Process
and U.S. Biosimilar Markets [I entered in media res]
· Eva Temkin, Acting Director for Policy, Office of Therapeutic Biologics
and Biosimilars, CDER, FDA
· Christine Simmon, Executive Director, Biosimilars Council, AAM: barriers
to entry for biosimilars: exclusionary contracts, rebates, stakeholder
misinformation. misinformation can include explicit and implicit, including
policies such as naming conventions and the very existence of the interchangeable
category, which is unique to the US. [I
think she was saying that the existence of the interchangeable category may
mislead consumers about the suitability of the existing approved biosimilars;
right now all approved biosimilars are approved for substitution but not for
interchangeability, the latter of which means that there’s evidence that
patients can go back and forth between the drugs as opposed to switching once.]
· Molly Burich, Director of Public Policy, Boehringer Ingelheim
· Surya Singh, President, Singh Healthcare Advisors, LLC
Moderated Panel Discussion
Meredyth Andrus, Attorney,
Health Care Division, Bureau of Competition, FTC
Does the designation
of interchangeability still have value in the US?
[I don’t think I can
attribute statements given where I am in the room and what I can see.] Depends
on the product. Primary draw: automatic substitution that can occur at pharmacy
level. If the drug isn’t distributed that way, then there isn’t much point. All
15 approved/in use products are physician administered. There are several
approved self-administered biosimilars, but none actually launched; have some
time before we see products where interchangeability would make a difference.
Have heard from
pharmacists that a different name may deter them from switching/may deter
patients. Some state laws on this may also have to be addressed.
Why are 11 of 26 biosimilars
approved not actively marketed in the US?
Singh: (1) patent
thickets. One drug has over 100 patents, 89 of which filed after the drug was
launched. (2) commercial & contracting issues. Same manufacturers/partners
are innovator/originator of biologic and also of biosimilar. (3) Rebates.
Different on medical benefit (physician-administered) side from pharmacy
benefit side. If a few major entities are doing most of the contracting on the
pharmacy benefit side, bundling is more common compared to more splintered
market for doctor-administered drugs. Manufacturers are waiting to see if the
rebate trap is going to be addressed.
Susan Collins introduced
bill to require patents to be listed in Purple Book for biosimilars. Would help
litigation, clarity. $3 million to litigate a patent, which is a big expense. Humira:
5 biosimilars approved, none on the market; some will be entering, but only b/c
of patent settlement agreements. 11 years earlier than otherwise might be
possible. FTC has done a lot to ensure that patent settlement agreements are
pro-competitive; put the rest the idea of pay for delay. Inter partes review is
good but is under threat.
of market structure/treatment modalities] doesn’t think that misinformation
influences providers’ decisions. Survey data, leaders at large practices: there’s
no more reluctance to use biosimilars. The market is being driven by economics.
[One way to read this is as a terrific indictment of our broken health care
system.] Explanation of how contracts
can limit doctors from using the drug of choice for patients: specialty
pharmacy delivers drug to practice despite what they have chosen for inventory.
“Fail first” policies are used extensively and increasingly for medical benefit
(doctor delivered) drugs to ensure use of their preferred drugs. When a practice
chooses what biosimilar to prescribe, it’s in inventory and interchangeability
doesn’t matter. Pharmacy benefit side: now interchangeability does matter—the pharmacy
needs the right to substitute w/o going back to prescriber, and the only way to
get that right is interchangeability.
FDA and FTC
Approaches to Help Ensure Truthful and Non‐misleading Advertising and
Principal Associate Commissioner for Policy, FDA: have seen troubling
communications suggesting biosimilars are less safe/less effective than
reference products or that there may be clinically meaningful differences b/t
them when biosimilars can’t be approved unless there are no clinically
meaningful differences. Even absence of explicit falsity can be misleading
overall and potentially harmful to public health by series of statements each
true on its own but misleading overall in combination w/omissions. Seen this
before w/Hatch-Waxman w/communications about generics suggesting they were
outdated or less effective.
Regulatory Counsel, Office of Prescription Drug Promotion, CDER,
FDA: Fair balance is
required in labeling/ads. FDA relies on statutory authority to regulate
labeling/ads. OPDP: Surveillance/communication program, including response to
voluntary requests for comment on draft materials; industry guidance; social
science research program (researches issues on DTC and advertising to physicians—learn
about studies on their website);
review of disseminated materials/ “BadAd” program/warning or untitled letters;
work with DOJ to pursue enforcement actions.
observed by OPDP in prescription drug ads & promotional labeling: omission
of risk; minimization of risk; overstating effectiveness (unsupported
claims/misrepresent data from clinical studies); misleading drug comparisons
(e.g., comparing two different studies that may have different patient
populations or methodologies). Warning letters 2015-2020: omissions/minimization
of risk are largest share of letters, but false/misleading comparative/benefit
claims are also taken seriously.
Assistant Director, Advertising Practices, Bureau of Consumer Protection, FTC: FTC
covers only commercial speech. Looks to content (promoting demand for a
product/service or denigrating competitor’s product; specific product references;
information about type, price, quality or other attributes, including health
benefits); means used to publish the speech (would it be recognized as
advertising); and speaker’s economic motivation for disseminating speech. Peer
reviewed scientific article or press release may or may not be commercial
speech depending on how disseminated/used.
is covered including failure to disclose that is misleading. Companies are
responsible for both express and implied claims. Net impression is what
matters, to a reasonable person in target audience. Thus net impression may
differ as between an ad targeted to a diabetes patient or a doctor treating
diabetes. Reasonable consumers don’t read an entire ad; a footnote will rarely
alter the net impression. Reasonable doesn’t have to mean majority; if a significant
number of consumers would take a message away then the advertiser is responsible
for that message. Can be liable for
misleading interpretation even though a nonmisleading interpretation is
possible. A consumer might interpret the use of “not interchangeable” in a
misleading way—to mean that a biosimilar couldn’t be prescribed in place of the
clinically meaningful differences b/t reference product & biosimilar; “there’s
still a chance the patient may react differently”; claims about greater safety
of reference product. Could all be false, unsubstantiated, and failing to
disclose material information.
FDA Draft Guidance
for Industry: Promotional Labeling and Advertising Considerations for
Biological Reference and Biosimilar Products Questions and Answers
Staff Director, Office of Prescription Drug Promotion, CDER, FDA
Elizabeth Pepinsky, Health
Science Policy Analyst, Office of Prescription Drug Promotion,
CDER, FDA: Draft
guidance issued by OPDP in consultation w/other groups focusing on biosimilars.
The basic rules are the same: truthful and nonmisleading, risk/benefit balance,
and disclose material facts. Companies should specifically identify the
product/products to which the information applies: e.g., if it applies to reference
product & biosimilars, say that; if promo materials use studies referencing
non US licensed comparator, then that status should be accurately identified in
the materials. If presenting info from
studies on reference product that are relevant to conditions of use for
biosimilar, should refer to biosimilar’s FDA-approved labeling for information
about the biosimilar. Data from studies conducted to support biosimilarity that
aren’t included in the FDA-approved labeling should, if presented, be truthful,
nonmisleading, and consistent w/FDA-approved labeling. Statements implying
superiority where the differences in adverse reactions are not clinically
meaningful would be misleading. Individual statements of accurate information
could contribute to a misleading presentation when provided in comparative
context. E.g., if biosimilar is licensed for fewer indications than reference
product, a comparative presentation suggesting less safety in the licensed
indications would be misleading.
Regulatory Counsel, Office of Prescription Drug Promotion, CDER,
FDA: Examples of
presentations that conform w/guidance. Scenario: promo materials say that one
drug in a clinical study had a numerically higher overall response rate than
another drug, but it’s not clinically significant: touting the numerically
higher response rate would be misleading. Looking forward to stakeholder input
on draft guidance, especially about how to convey interchangeable information.
Pepinsky: keep net
impression in mind: individual claims aren’t enough to be nonmisleading about
safety and efficacy, not just for comparative claims but for all claims.
What’s at Stake? The Benefits of Competition
Regulatory Counsel, Office of Therapeutic Biologics and Biosimilars, CDER,
• Murray Aitken,
Executive Director, IQVIA Institute: Many dynamics in market. Biologics=growing
share of market with significant growth over 5 yrs relative to small molecule.
42% of total medicine market by price in 2018, up from 30% in 2014; represents almost
all of the growth; adjusting for inflation and population growth/per capita
spending, small molecules declined 12% while biologics increased 50%. R&D
pipeline suggests growth will continue across most disease areas, including
those traditionally based on small molecules. Reach market through multiple
channels & pay times, each w/own payment dynamics, including private
insurance, Medicare types (both pharmacy and physician provided), Medicaid
(ditto), fee for service, cash, commercial office/physician sites. Different
incentives, reimbursement levels for each segment. Largest originator brands
have significant sales since launch: each of the top 10 has cumulative sales of
over $40 billion since launch, on market more than 17 years.
About 40% of small molecule
market sales are accessible to generics. By 2019, 17% of biologics market is
accessible to biosimilars, which have 20% market share. Including approved but
not launched, 50% of biologic market sales could face biosimilar competition
(that won’t happen until 2023 at the earliest).
[I think] David R.
Schmidt, Assistant Director, Applied Research and Outreach, FTC It’s early days for biosimilars, and early to
be analyzing these markets. Look at whether different payors (and dispensing
location) are treating biosimilars differently from the small molecule drugs
those payors handle.
Director, Economics, Office of Program and Strategic Analysis, CDER, FDA: Also
lessons in comparing different biologics. W/generics, we don’t see wide
disparities by payor type. Reasonable to think that there shouldn’t be. Would
be concerned if saw very different behaviors in Medicaid and non-Medicaid markets.
• Inma Hernandez,
Assistant Professor of Pharmacy and Therapeutics, University of Pittsburgh
School of Pharmacy: W/o interchangeability, we can’t pay for biosimilars the
way we’ve been paying for generics.
Discounts are proprietary so we have trouble knowing what payors
actually pay. Have some data from SSR Health; calculating average revenue for
unit of product, net of discounts including rebates and other discounts
including cards given to patients. Can separately estimate for Medicaid and
other payors. Have showed robustness of data in paper in JAMA. One example of
biosimilar entry: List and net prices increased in parallel until 2013; net
prices started to decrease in 2015 when competition began, driven by increasing
discounts to payors other than Medicaid. Another three examples: similar story,
sometimes net prices begin to drift down before entry. Sometimes there are
factors other than biosimilars (here: in-class competition by non-biosimilar
drugs), also including public pressure over insulin prices for one of the
examples, insulin glargine. List prices stagnated after competition, but net
prices decreased due to discounts. Unclear whether decreases related to number of
biosimilars or only number of years post-biosimilar entry.
What about rebates for
drugs covered under Medicaid managed care organizations, collected by states pursuant
to ACA? Market share of Basaglar (biosimilar to initial version of insulin
glargine) is basically zero unless states have MCOs with no preferred drug lists
(there are several other possible models). Preferred drug lists prevented
uptake by listing it as non-preferred; results reflect strong financial
incentives of rebates. More states are implementing preferred drug lists, so
this is a timely result. Competition is
happening in discount, not in list price.
Comment by someone:
seeing very different behavior for reference products in biologics space v.
responses to generics in small molecules.
Aitken: we should
get beyond saying they’re different from small molecules and say that fee for
service Medicaid is different from managed care Medicaid and so on.
Alex Brill, Resident
Fellow, American Enterprise Institute: Barriers to competition can be good and
bad, big and small. Barriers to biosimilar entry: some are appropriate to
protect innovator/producers and consumers (patents, exclusivity periods, approval
process); others thwart healthy competition. Barriers to biosimilar utilization
once entry occurs are uniformly bad. Bad barriers: myopic contracting practices
by payors that discourage maturing of biosimilar marketplace; rebate traps;
frivolous late-stage patents; inadequate physician and patient education not
comparable to education that has taken place for small molecule generics.
Undue barriers to
biosimilar entry/utilization: extends excessive monopoly rents; higher patient cost;
less biosimilar discounting; fewer biosimilar competitors. Uncertainty
associated w/ the viability of the market is a barrier: uncertainty of
reference product price; legislative/legal/regulatory uncertainty; competitor
biosimilar behavior—many of these are natural in a free market and will resolve
over time w/experience, but we can strive to mitigate them. Exclusivity periods
are specific and clear w/clear duration; patent thickets lack predictability. Regulators
should try to minimize costs related to approval. Should be willing to incentivize
participants to stop waiting—manufacturers, prescribers waiting for more
information. Worth considering goosing the system to get over initial hurdle.
Stakeholder Engagement: Education and
Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars,
FDA has health care
provider materials/fact sheets. Biosimilar basics for patients. Working on
additional materials. Highlights similarities of biosimilars and reference biologics,
benefits of increased access; urges patients to find out more from doctors/FDA.
Going to create fact sheet for health care providers to address misconceptions,
as well as teaching resources for medical/pharmacy/nursing schools.
Attorney Advisor, Office of Policy Planning, FTC
• Cheryl Koehn,
Founder & President, Arthritis Consumer Experts: emphasizes importance of
disclosure of material connections. Patients have seen white noise about
safety/efficacy/lack of identicality/lack of interchangeability from
originators: contributes to nocebo effect. Nocebo effect is real. Negative
words, body language, subtle or not-so-subtle words are import and
strategically deployed. Canada is ahead in switching: several provinces have switched
most patients to biosimilars, with about 1% requesting exemptions and 1%
granted. Can buy a lot of health care for $2 billion Canadian.
• Sameer Awsare,
Associate Executive Director, The Permanente Medical Group: 12 million
patients, $8 billion on pharma. Business model for drug use management is
predicated on ability to move market share. Leverage exists b/c KP can deliver
more than 90% of given market in short time; 12.2 million members are aout 4%
of covered lives. Physician & pharmacist driven drug selection allows KP to
promise & deliver, moving market w/99% physician compliance. Education of
physicians & pharmacists with general biosimilar education; biosimilar
data; then were able to show that KP patients did well. 80% of KP patients
using Remicade successfully switched to biosimilar Inflectra; used medical
records to guide the switch and to show outcomes. Found no increased risk of
disease worsening in IBD patients switched to Inflectra. Similar experiences
w/two other biosimilars. Once doctors were comfortable with the first biosimilar
they were more willing to switch to others.
• Michele Andwele,
Editorial Director for Health Content, Arthritis Foundation: key concerns:
effectiveness? Could switching from reference product make me flare up? Are they
safe? Will I pay less? Can a pharmacist substitute w/o doctor’s approval? One patient: I pay $35/month; don’t have a
financial incentive to switch if it’s working for me. Language matters: inconsistent terminology
use/unconscious bias in communication w/patients. Need provider
consensus/patient advocacy group consensus on how products are described.
Provider concerns: time constraints in discussing biosimilars in short time w/patients
who may have many issues. Insurance coverage/patient assistance programs are
issues; liability exposure in absence of interchangeability designation. Educational initiatives shouldn’t be
influenced by industry; learn from partners in Canada and Europe.
• Hillel P. Cohen,
Executive Director, Scientific Affairs, Sandoz (trade group rep for Biosimilars
Forum): has seen several types of disparagement. Information that is technically
correct but omits info; negative framing of factual statements that matters to
consumers. Sometimes factually incorrect claims. Safety, quality, and
regulatory messages. E.g., efficacy is not fully proven, or may not be as good
as the reference product. Seen comments about extrapolation: some doctors/patients
say extrapolation is inappropriate. Seen safety not fully proven, or potential
for more bad effects. Switching: there are comments that we don’t have enough data
to conclude that switching is safe, implying that it may be unsafe. Doctors can
already prescribe the appropriate product; you don’t need interchangeability
for that. Quality: that it may not be the same as the reference product/it’s
only similar or highly similar, not identical, even though differences aren’t
clinically relevant—that’s difficult to understand. Statements that
interchangeability is a higher standard, implying that biosimilars are of lower
quality than interchangeable biologics, even though they are structurally
identical. Regulatory pathway has created some of the problem: “abbreviated”
pathway. Some people say it’s not as rigorous as pathway for reference products,
truthful & complete information should be required. Positive framing of
benefits; easy to understand messages. Messages should be based on FDA
documents but tailored to their audiences. Large orgs and patient advocacy groups
have done the research and are on board w/biosimilars, but the average patient
is not knowledgeable. Need to educate them, via educating physicians—rheumatologists
know more than gastroenterologists right now.
FDA should prevent disparagement/misinformation. Incorporate biosimilar
education into educational curriculum for doctors, nurses, pharmacists. Patient
groups should disclose funding & conflicts of interests—it’s fine to speak
your positions, but full disclosure is important.
Koehn: on language,
biosimilars are biologics; if you use two different terms people think
they’re not the same thing.
Andwele: Also need
an influencer strategy: patients as peers.
Cohen: highlight the
rigor of the process used to approve the biosimilar. Sound scientific policy.
Doctors are used to clinical trials; it’s a different methodology, but does
assure safety & efficacy. Coordinated effort w/professional societies and
patient groups is necessary.
segmentation. Treatment-naïve patients v. someone stable on a biologic.
Disparagement as an Antitrust or Consumer Protection Cause of Action
• Richard Cleland,
Assistant Director, Advertising Practices, Bureau of Consumer
• Randall Weinsten,
Attorney, Health Care Division, Bureau of Competition, FTC
Michael A. Carrier,
Distinguished Professor, Rutgers Law School: statements like “we need to
proceed cautiously so we don’t end up with another thalidomide, or all the things
that happen when safety isn’t considered”; claims that it would disrupt
continuity of care/could put patient in ER/could bring patient out of
remission. Not appropriate given definition of biosimilars.
More subtle: claims
that the biosimilar is not identical to, or acts differently from, reference
product. Pfizer citizen petition contains many claims: it’s not just apples to
apples; patient may react differently. Genentech says: the FDA requires highly
similar but not identical. FDA is good at taking on these misrepresentations.
interchangeability. There are some intimations that not interchangeable = not
meeting highest standards of safety & efficacy.
Most subtly: company
says the drug acts “similarly.” Jansen says “you may be asked to switch to a drug
that acts similar to Remicade.” FDA’s
guidance addresses that.
Frank Stanton Professor of First Amendment Law, Harvard Law School
Elements of a Lanham
Act claim: key elements are falsity or misleadingness, materiality to a
reasonable consumer’s purchase decision, and likelihood of harm to the
Mostly unique to the
Lanham Act cause of action, compared to an FTC or state consumer protection law
claim: the sharp doctrinal difference between false and misleading claims.
Although both falsity and misleadingness are actionable, the burden on the
challenger is much greater if a claim is misleading than if it is literally
false. That puts a premium on distinguishing falsity from misleadingness. How
does a plaintiff establish a claim is false? Courts ask: What is the explicit
meaning of a claim. Once you know the explicit meaning, you can then determine
whether that factual claim is false. However, sometimes courts are willing to
make general inferences from disparagement. Also important to distinguish lay
audiences and expert audiences: dictionary meaning may not be as important as
what people are likely to understand.
How does a plaintiff
establish a claim is misleading? Relevant when the claim is ambiguous and has
potentially true and potentially false meanings; the question is what message
reasonable consumers receive. Usually through surveys of the relevant
consumers. If 15% or more of consumers, net of control, receive a false message,
then P is likely to prevail.
When is empirical
evidence of consumer reaction necessary? Not in literal falsity cases; literal
falsity is presumed to reach a substantial number of reasonable consumers. Basically
always required in misleadingness cases. [Intent, direct testimony from
deceived consumers as possible but unlikely substitutes] 7th Circuit case, Eli
Lilly v. Arla Foods (2018): Eli Lilly sued over images portraying rBST, a
hormone given to cows to increase milk production, as a scary toothed monster
with electric fur. The 7th Circuit finds there’s no literal falsity, but still
affirms an injunction: “The use of monster imagery, ‘weird stuff’ language, and
child actors combine to colorfully communicate the message that responsible
consumers should be concerned about rbST-derived dairy products.”
Impact of First
Amendment: Courts have generally said that the Lanham Act false advertising
cause of action raises no constitutional issues because by definition it
targets only false or misleading commercial speech, which can constitutionally
According to Supreme
Court doctrine, when it comes to direct gov’t regulation of speech, there is a
distinction between inherently or actually misleading v. potentially
misleading: Whether the speech can just be banned or whether instead a
disclosure must be added to try to draw the sting of the misleadingness. This
isn’t well worked out and has largely been done by courts guessing, or worse,
about what’s inherently or actually misleading versus correctable and only
potentially misleading. Much room for presenting courts with facts about
misleadingness. Not the same distinction
as is made in Lanham Act cases, where misleadingness is grouped into one
category distinct from falsity.
private and public enforcement: Courts in private litigation often defer to the
FDA’s factual findings about what is true but without a lot of explanation
about why they’re deferring.
First Amendment may
also bear on the question of de novo review of agency determinations: what are
the medical facts versus what are consumers’ perceptions of the messages they
receive? The former—the facts of safety
and efficacy—may as a practical matter receive more deference than agency determinations
about misleadingness, even though both are subject to ordinary mechanisms of
Q: role of consumer
RT: likely to be
limited b/c of barriers to class actions.
Cleland: POM case:
DC Circuit said deceptive = no First Amendment protection. Should go into
relief ordered, not into whether it is actionable.
RT: agree, but
courts are often not great at signaling their order of operations.
RT: to consumers,
which then affects competitors when consumers’ decisions are affected. [in
response to Q] Could be patients or doctors; both have substantial influence on
what drugs are prescribed.
monopolization claims: these are highly concentrated markets, w/few
substitutes. Liability requires monopoly power + exclusionary conduct. Some courts
have rejected any liability for disparagement; others have made it very hard/impossible
to find liability; others say it’s case by case. In the first bucket, 5th &
7th circuits say that false advertising is pro-competitive by increasing
competition in the market for advertising. This is nonsense. It’s at least
possible to get/maintain monopoly power by disparaging rivals. Rivals can’t fix
it; can have significant effect on overall market.
Second approach: de
minimis rule: assumes disparagement is de minimis without a showing of lots of
things: clearly false, clearly material, clearly likely to induce reasonable
reliance, made to buyers w/o knowledge, continued for prolonged periods, not
subject to neutralization. The bar is just too high—taken from leading
Areeda/Hovenkamp treatise. Was adopted at a time when the standards for false
advertsing weren’t clear. There are a lot of instances of false advertising that
aren’t monopolization, but false advertising in a monopoly context can harm
Clearly false: you
can have deceptive statements even if they aren’t clearly false, as has been
delineated here. That standard is too high.
Clearly material: yes, deals with safety/health; would induce reasonable
reliance for that reason. Knowledge of subject matter: the drug companies have
better knowledge. These drug monopolies go on for years. It’s hard to
neutralize: biologic company says “you could go to the ER” and that’s tough to
Third bucket: case
by case approach of 3d, 8th, and DC. False statements can be so unfair as to
constitute an unreasonable restraint: e.g., does it lock in decisionmaking? Does
it make it harder for competitor to get financing? Hard to get financing if you’re
subject to claims about safety/efficacy. Relevant also: the regulatory setting.
Wonderful to see FDA/FTC working on this, but the agencies might not be able to
solve the problem on their own. Drug companies think it’s in their bottom line
interest to get away w/slap on wrist, maintain monopoly power. Role for courts
to police barriers to entry, especially given other barriers to entry like
trade secrets, patent thickets, etc. Bundling existing and new patients makes
it harder for new patients to get the biosimilar.
Weinstein: do we
need private antitrust enforcement?
Carrier: we need all
three: private antitrust, false advertising, and regulatory enforcement. No
matter what agencies can do, bad actors may be able to cross the line and
commit antitrust violations. The benefit is that it focuses on market effects:
increased price, reduced output—antitrust is uniquely able to deal with that.
It has treble damages, attorneys’ fees, injunctions: it can consider all kinds
of anticompetitive conduct in their full context and interactions. Suboxone: an
overall course of conduct can violate the law. The companies aren’t doing just
one thing, they’re pursuing many strategies.
Weinstein: would a consumer
class action work here?
Carrier: courts aren’t
always receptive, especially given the nuanced role of the misinformation here.
FTC uniquely has §5 power to go after unfair/deceptive acts or practices, with
more leeway than private antitrust.
RT: Right now some
courts do a “heads I win, tails you lose” approach: Becton Dickinson in the 5th
Circuit, P lost its antitrust claim because false advertising couldn’t affect
the market in general, then lost its false advertising claim b/c it affected the
market in general and P couldn’t show which of the sales it had lost v. its
forthcoming article (watch this space) lays out how you should think about presuming
anticompetitive effect when false advertising is done by a monopolist. Our test
applies to monopolists, and it doesn’t make all false advertising into an antitrust
problem. We take the learning from false advertising law and apply it to
antitrust: a well developed body of law.
We’d need to figure
out what it takes to have real competition in biologics.
Q: how do you
establish competitive harm? Is deception enough?
Carrier: for a
biologic w/monopoly power, I think that’s enough. Biosimilars are injured;
regulatory scheme is impaired b/c biosimilars are supposed to play a crucial
role in lowering price. Competitor harm = consumer harm.
Q: belief that it
would be hard to deceive prescribing physicians about safety/effectiveness. If
true, is there still a role here for harm to competition?
Carrier: yes, b/c we
have a price disconnect. Not like any other market where price/quality
determination is made by any one party. Doctors, payors/insurers, consumers:
lots of room for anticompetitive conduct w/r/t patients and pharmacy benefit
managers. Pharma gives us whack a mole
all the time: every time you think you’ve figured out what is going on, there’s
something else. Gilead case: new combination of settlements and product hopping
we haven’t seen any more. Transferred patents to Native American tribe to try
to avoid PTO review. This is just the next stage in that process of invention.
Antitrust is well equipped to deal w/variety of shenanigans.
Q: rulemaking as a
possibility. Comm’r Chopra wants more FTC rulemaking.
Carrier: may well be
useful. Yes to rulemaking and yes to enforcement in the courts. Could shed
light on the problem, as does the guidance FDA has offered. Make clear you can’t
hide behind clear falsity: deception/misleadingness is a problem.
Q: gov’t v. private
Carrier: sometimes this conduct is nuanced. Safety intimations; an ideal recipe
for FTC action.
RT: at some point
companies should step up and go to court to defend their own interests if they’re
losing millions. But public harm also matters and can justify gov’t intervention.
Antitrust prides itself on its hard-headed empiricism but the majority tests presently
ignore all the learning we have about false advertising’s effects. That should
Carrier: Pfizer is
suing J&J; it is possible, b/c entering the market w/ a biosimilar requires
lots of resources.
• Sarah Ikenberry,
Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars,
• Eva Temkin, Acting
Director for Policy, Office of Therapeutic Biologics and Biosimilars, CDER,
• Catherine Gray,
Staff Director, Office of Prescription Drug Promotion, CDER, FDA
• Antara Dutta,
Economist, Bureau of Economics, FTC
• Armine Black, Attorney,
Health Care Division, Bureau of Competition, FTC
Juliana Reed, Pfizer/
Biosimilars Forum: continued problems of misleadingness, but that’s not the
U Pitt pharmacy
school professor: Europeans are fine prescribing biosimilars b/c of nearly 2
decades of experience. Physician confidence is high uniformly but uptake varies
by country, which probably reflects other factors including payor practices.
Health care practitioners in the US are also not skeptical; they are enthusiastic
Marilyn Feldman, Alliance
for Safe Biologic Medicines: rheumatologists were willing to prescribe, but
clinicians are often hesitant to change b/c it can take years to stabilize a
patient. And they’ve become sensitized to non-medical changes based on
formularies that have changed patients’ medicines every 6 months in order to
make higher profits. They even switch patients to completely different
biologics. So doctors are leery of a great switching experiment. Biosimilars
are behind the 8-ball because of financial incentives. Incentives that benefit
the physician can undermine trust in doctors. Considering the perception that
US lags behind Europe, 5 years out there were 11 products but we have 26: FDA
deserves thanks for building out approval so quickly.
Sundar Raman [sp],
biosimilar company: Data for biosimilarity should also suffice for interchangeability;
no more is required and practically they are already interchangeable. But the
difference allows anticompetitive behavior by originators, including misrepresentations
and payment practices.
Andrew Spiegel, GCCA,
Alliance for Safe Biologic Medicines: Unaware of any attempt to undermine
confidence of patients & doctors in biosimilars. Patients & providers
have accepted biosimilars as part of health care.
pharmacist, PCMA (pharm benefit manager ass’n): 270 million Americans in
covered plans. Patent thickets are bad; product substitution is good—should lower
barriers to substitutions. Patients & clinicians may be uncertain about switching/substitution.
Jansen Pharm./J&J: patients should have data on alternating before that
happens; implying that alteration/interchangeability is fine for a biosimilar
is misleading w/o data. Some molecules are more immunogenic than others; patients
may face switching every 6 months and need good info.
Ad compliance guy:
Dr. Google is often the driver of patients to particular sites. FDA Warning
letter last month specific to search ads on Google: request that final guidance
documents specifically get into how biosimilar guidance applies to marketing
platforms w/character space limits, and to brand-connected ads: ads that don’t
mention a brand themselves and then link directly to a brand website.
seen disparagement in educational materials, offices, etc. Don’t believe that’s
responsible for impaired patient access. The access problem, which exists, lies
elsewhere. Manipulations designed to maximize profits from fees, rebates, and
other schemes. Don’t address those and access won’t happen; far outweigh the
effects of deceptive marketing. Formulary decisions are rarely if ever based on
medical outcomes. Overly consolidated industry of unregulated middlemen with
unfettered power demanding ever increasing tolls from patients and pharmacos.
Major driver of rising costs. Should not be allowed to continue. Insurers,
large pharmacies, and PBM conglomerates are main barriers to access for biosimilars
and indeed all pharmaceuticals.
Laura Brandt (sp),
Amgen: US market is emerging but robust; the current market structure is good.
Andre Barlow (sp) on
behalf of Coalition to Protect Patient Choice: highlights the role of rebate walls:
agencies should prohibit rebate policies that block biosimilar competition.
Such policies raise the cost of drugs overall. Go to PBMs rather than
consumers; perverse incentives to negotiate higher list prices, requiring
higher coinsurance payments from patients b/c of higher list costs. Rebate
wall/trap: use existing market power to secure formulary access w/volume based
rebates on condition that they deny formulary access to rival drugs, bundled across
drugs for many conditions that can’t be matched by new entrants—even if the
biosimilar is offered at greater discount or for free. Most PBMs require
patients to fail first on the more expensive branded drugs, instead of the
historical fail first on generic requirements. Step therapy rules used to
PhRMA rep: Physician
education is good. Meaningful rebate reform would promote access and competition.
(sp) Global Health & Living Foundation: nonprofit for chronically ill
patients. Pricing is the key. Nonmedical switching needs to be defined;
patients/doctors should be able to nonmedically switch when it benefits them,
not when it benefits the PBM. Forced nonmedical switching only profits PBMs/insurers.
Patient is the only one who shows up w/a checkbook and no power. You can change
this by strictly regulating insurance practices & creating market
incentives for uptake.
Pfizer: Should be able to extrapolate for additional indications even in the
absence of clinical data, speed up approvals. Biosimilar exclusion contracts withholding
rebates for both current and future patients exclude biosimilars. Prevents doctors/patients
from trying biosimilars.
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