Remarks at FDA Public Hearing on Biosimilars

Association for Accessible Medicines’ Biosimilars Council Remarks at FDA Biosimilars Public Hearing, “Facilitating Competition and Innovation in the Biological Products Marketplace”

As delivered by Christine Simmon, Biosimilars Council Executive Director and AAM Senior Vice President of Policy and Strategic Alliances

Thank you and good afternoon. On behalf of AAM and its Biosimilars Council, I thank the Agency for its leadership on biosimilars, especially in partnering with industry, patient, provider, and payor stakeholders that want to improve patient access to biosimilars.

As policymakers from the president to state governors grapple with high drug prices, biosimilars represent new savings and access for patients and payors. Unfortunately, biosimilars face challenges getting into and then staying on the market. While the FDA has approved 12 biosimilars, only 4 of these are currently on the market. Dr. Gottlieb recently remarked that, if all of the FDA-approved biosimilars in 2017 were successfully marketed Americans could have saved more than $4.5 billion last year alone.

This illustrates the unfortunate truth that FDA approval of a more affordable version of a medicine does not guarantee the medicines get into the hands of patients and it doesn’t guarantee the health care system accrues the savings.

You’ve heard more than a dozen speakers give you their views on how FDA can advance biosimilar competition, per your questions.

But I want to start with this: FDA is more than a regulator of biosimilars. FDA is the most credible federal resource on biosimilars. Which makes the agency a key influencer – well-positioned to collaborate within HHS, with CMS and other agencies such as USTR and PTO, as well as Congress, to advance biosimilar competition.

We know that much of what is holding back biosimilars from patients requires policymakers to build on actions the FDA already has taken or will take under the Biosimilars Action Plan. As the Administration continues to implement its Blueprint and tout its progress, FDA is the engine that can drive policymakers on biosimilars opportunities.

So let’s start with those issues where FDA’s credibility can drive policy wins for patients.

Reimbursement in Medicare

A sustainable biosimilars market depends on well-designed FDA regulations combined with market incentives created by CMS payment and formulary review policy.

Predictable reimbursement and market access is critically important. Would-be biosimilar manufacturers can’t justify allocating significant capital into development programs without a reasonable potential for commercial success. CMS has taken important steps to support biosimilars, but rebate traps, exclusionary contracting and a lack of reimbursement incentives remain barriers.

We encourage FDA to work with HHS and CMS to ensure that Medicare reimbursement and formulary design prioritize utilization of these lower-cost, life-saving medicines.

Combatting Patent Shenanigans

AAM and the Biosimilars Council strongly support innovation.  That said, efforts by some brand-name pharmaceutical manufacturers to manipulate the patent system through “patent thickets” that extend their market exclusivity beyond Congressional intent are a primary reason FDA-approved biosimilars cannot timely enter the marketplace and get into the hands of patients. These patent thickets not only delay entry, but chill competition overall because of the exorbitant cost of litigating meritless patents.

We urge FDA to work with the Patent and Trademark Office to stem the issuance of non-innovative patents and support the use of inter-partes review (IPR). IPRs provide biosimilar manufacturers an earlier and more accurate picture of the patent landscape in a timely and less expensive manner.

We are also deeply concerned that the recently announced U.S.-Mexico trade understanding to extend brand name biologic data protection to 10 years will harm patients and the nascent biosimilar industry. We believe that USTR’s efforts actually undermine both the President’s blueprint and the Biosimilar Action Plan and we encourage FDA to work with USTR and advocate for the rejection of these provisions.

Access to Reference Product

Finally, we appreciate the FDA’s commitment to naming the companies seeking to block competitor acquisition of reference product samples via restricted distribution schemes to try to deter such conduct.

However, a study released today by Matrix Global Advisors reveals the growing cost of these abuses with annual lost savings exceeding $13 billion. This is nearly triple the annual lost savings number of just four years ago.

The bipartisan CREATES Act would prohibit brand pharmaceutical companies from restricting access to samples to delay biosimilar competition. We are not aware of any companies who have changed their practices as a result of FDA’s naming & shaming –– Congress needs to act and we urge FDA to work with Congress and help pass this important legislation.

I will now touch on some of the questions in the hearing notice.

Education

We applaud FDA’s introduction of provider educational materials about biosimilar products. FDA is the single-most credible resource for stakeholders—especially patients and their health care providers— seeking information about biosimilars.

We urge the agency to expand its efforts to promote and instill confidence in biosimilar safety, efficacy and quality. This should include using understandable terminology and prioritizing stakeholders who stand to benefit most from these resources.

We also agree with those urging FDA via the citizen petition process to address misinformation campaigns that are damaging market confidence in biosimilars.

We believe this includes making clear that so-called “non-medical switching” is a red herring and that it does not apply to FDA-approved biosimilars. In fact, patients are routinely switched from one biologic to another if the treating physician deems such a change the appropriate course of treatment.

In Europe, physician-led switching from a brand biologic to a biosimilar is common, and extensive data shows that a one-time switch from a brand biologic to a biosimilar does not carry increased risk of an adverse event. This is but one way in which false and misleading information undermines public confidence in the safety and effectiveness of biosimilars. FDA should address all forms of these tactics by highlighting the evidence around the safety of biosimilars and by vigorously addressing permissable communication by sponsors.

Also, it is important for the FDA to continue to make clear that an interchangeability designation does not indicate a “better” biosimilar than one approved absent that designation. We believe this misperception is gaining traction among payors and delaying biosimilar uptake.

Purple Book

We ask FDA to update the Purple Book to list which products have been determined not to have exclusivity and those that are still subject to pending decisions. as well as by adding the same guidance about interchangeability as it does in the Orange Book.

Carve Out

Currently, FDA allows biosimilars manufacturers to “carve out” specific indications protected by patents from their label. When those patents expire, FDA expects developers will seek licensure of their product for those “carved out” conditions.  As biosimilars developers battle through “patent thickets”, this practice is increasingly important. If a biosimilar label cannot exclude these indications, the manufacturer might not be able to launch without risking infringement of that later expiring patent. This causes lost savings and harms patient access.

AAM supports FDA continuation of its current policy.

Facilitating Development

AAM strongly supports eliminating the requirement for sponsors to conduct expensive and unnecessary bridging studies when using non-US-licensed reference product.

But we are concerned that several aspects of the Draft Guidance on Interchangeability “Considerations in Demonstrating Interchangeability with a Reference Product” impose unnecessarily burdensome scientific standards on interchangeability determinations and/or are inconsistent with statutory requirements. If finalized, these requirements not only will create significant disincentives for sponsors to develop interchangeable biologics but, more importantly, will also significantly affect patient access.

We look forward to submitting written comments responding more fully to the agency’s request for feedback. Thank you.