Last week, the Senate Committee on Health, Education, Labor & Pensions Subcommittee on Primary Health and Retirement Security held a hearing to discuss biosimilar implementation. Specifically, this panel focused on receiving insight from the U.S. Food and Drug Administration on the implementation of the Biologics Price Competition and Innovation Act of 2009 – the legislation driving biosimilars adoption in the United States. While this hearing is a positive step in the lengthy timeline of BPCIA implementation, the tone of the meeting was reflective of the current frustrations with biosimilar adoption – this pace is much too slow. With developed geographies including Europe and Australia reaping the benefits of biosimilars for years at this point, why is the U.S. trailing behind?
Most notable is the need for clear guidance on interchangeability. This pillar is essential to creating a supportive market for biosimilars growth, delivering greater access to patients, spurring system-wide innovation, and providing cost-savings for the healthcare system. Further, clear guidance(s) will encourage a greater number of players to enter the market, driving needed development and competition. But until we have a clear framework from the FDA, there will continue to be significant confusion, limiting development and threatening patient access to cost-effective life-saving drugs. As Sen. Elizabeth Warren (D-Mass.) noted, “I’m concerned misunderstandings over biosimilars will hamper uptake in the market.”
We must establish clear parameters demonstrating to physicians, pharmacists and patients, as articulated by FDA, that “avoid inaccurate perceptions of safety and effectiveness of biological products based on their licensure pathway”, viz. there are no clinical meaningful differences between biosimilars and a given reference product. Biosimilars developed to have a fingerprint-like identity to a reference product are an initial step in interchangeability; prompt guidance is needed to create a clear and achievable pathway toward interchangeable biosimilars supporting timely uptake of these medicines.
As stated by Subcommittee Chairman Sen. Bill Cassidy (R-La.) (a physician himself), a biosimilar and a reference product are akin to identical twins with different freckles – interchangeable for an indication. While there is some value in the FDA’s position that interchangeability may be established through clinical trials, it is also worth noting that between batches of the same biologic there may be minor differences, resulting in small discrepancies within the same reference product – no clinical “bridging” clinical studies are required. Moreover, formulation changes by reference product sponsors do not typically require clinical studies. By being inconsistent and insisting on clinical studies for biosimilar interchangeability, and not recognizing these formulation differences within a reference product are a similar milieu (notwithstanding a decade of experience in the EU with biosimilars) the FDA is creating confusion about biosimilars, impeding patient access, and limiting the adoption of these drugs in favor of more costly reference products.
The challenge today is for both FDA and biosimilar developers to work together to establish guidelines that drive biosimilar market growth. Our counterparts around the world have already seen first-hand the dramatic effects biosimilars can have on patients and systems when nurtured and supported. The longer the process of guidance development in interchangeability drags on, the more we stifle innovation in therapeutic development of these important medicines. Patients across the country deserve better.
Dr. Bert Liang is the founding and current CEO of Pfenex Inc., a biologics company focused on biodefense and providing access to biosimilars. He is formerly a practicing oncologist and neurologist.