Imagine a world where cutting-edge medicines developed to treat complex conditions like cancer and autoimmune diseases reach patients faster and at a lower cost. That’s the promise of biosimilar streamlining, an effort to modernize the U.S. development paradigm for biosimilars, the affordable alternative to expensive biologic drugs.
The U.S. Food and Drug Administration (FDA) approved its first biosimilar medicine in 2015, and since then, biosimilars have generated about $36 billion in savings. They have also resulted in over 495 million days of patient therapy that would not have occurred otherwise – making biosimilars a key tool in expanding access to life-saving medicines for Americans. Moreover, increased use of biosimilars allows health systems to redirect resources to other areas, such as improving infrastructure, enhancing healthcare services, and funding the development of additional therapies.
But there’s a problem! The development and regulatory process for biosimilars hasn’t kept pace with scientific advancements, which harms patients and the healthcare system. Thanks to advances in analytical methods, manufacturers and regulators can now more quickly and accurately confirm that biosimilars are just as safe and effective as the brand-name products. Yet, often, biosimilar developers are still required to conduct duplicative, costly, and time-consuming studies that don’t add real value.
The Biosimilars Council has proposed several ideas around how to achieve streamlined development of biosimilars. One such idea is to eliminate, in most cases, outdated requirements for regulatory approval without removing the FDA’s authority to require additional evidence when justified. One such outdated and usually unnecessary requirement is the need for a comparative clinical efficacy study, or a type of clinical trial that compares a proposed biosimilar product to its already-approved reference product in order to demonstrate clinical equivalence. In general, comparative clinical efficacy studies are not sensitive enough to detect differences between a biosimilar and reference product. Differences, if any, would have already been identified in earlier analytical testing prior to subjecting patients to an unnecessary clinical trial. And more, these unnecessary comparative clinical efficacy studies cost around half of the total estimated cost to develop a biosimilar, which lands between $100-300 million. Comparative clinical efficacy studies demand critical resources, delay competition, and deter investment in lower cost biosimilar alternatives without improving the quality, safety, or efficacy.
The result? Less competition and fewer biosimilars. High development costs associated with these products may reduce the number of biosimilars any given company will develop, leaving many reference biologics to dominate the market with no competition. And the stakes are high – a recent IQVIA report found that of 118 biologic patent expiries over the next decade, only 10% have biosimilar competition in development.That’s a missed opportunity for patients and for our healthcare system.
Biosimilar streamlining is about applying today’s science to meet today’s challenges. Embracing biosimilar streamlining means smarter, more targeted testing that harnesses modern scientific tools to ensure biosimilars remain just as safe and effective for patients as the reference biologic product. Biosimilar streamlining isn’t just a bureaucratic fix or a regulatory refinement, it is a critical solution to address the “biosimilar void,” bringing high-quality, affordable medicines to market more quickly and giving patients better, faster access to the treatments they need.
