At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals. The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals. Here are some of the points that Dr. Corrigan-Curay discussed:
- The FDA has approved a total of forty-five biosimilar products for fourteen reference products. Of these forty-five approvals, thirty-eight have gone to market. Other regulatory, patent, or exclusivity issues have kept the other seven off the market (for now).
- Of the biosimilar products that the Agency has approved, seven are designated as interchangeable. For four of the interchangeable products, the Agency did not consider comparative clinical immunogenicity studies necessary, and, for two of the products, no additional clinical data was required. Two of the interchangeable products required clinical switching studies, and one of the products will have its review package available in mid- to late February and we will see what was or was not required for that product then.
- The number of biosimilar biologic programs brought forth to the Agency has steadily increased since FY 2018, from about 78, to 120 in FY 2023.
- Dr. Corrigan-Curay discussed the Regulatory Science Pilot Program deliverables as its goals drive the development of the composition of the 351(k) data package that will be required for biosimilar applications.
While the FDA is having success in approving biosimilars, it is interesting to note that, during the CEO unplugged session at the AAM meeting, one of the major concerns that the four CEOs on the panel expressed was the problem with uptake of the approved biosimilars and the fact that insurance plans, PBMs, and government programs are hindering that access. They worry that if these barriers are not broken down, firms will be reticent to allocate the 100 million dollar plus investment that it takes to bring a biosimilar to market. One of the CEOs mentioned that this concern is not speculative as there are at least a few firms that heavily invested in biosimilars that have either sold or scrapped their biosimilar development programs, proof that this concern is valid.
The FDA does not define markets nor is its mission focused on the pricing aspects of the market. However, the Agency is concerned about education of the marketplace regarding the value of biosimilars as well as dispelling the misinformation that swirls around about them. The Agency has invested in multiple educational initiatives through digital campaigns as well as social media outreach programs. Because of the high price of biologic treatments, biosimilars have the potential to provide substantial savings to insurance companies, and, most importantly, to patients, and the FDA knows that the educational component is essential in bringing that message forward.
AAM provides a visible and influential role in supporting generic and biosimilar programs, and it is focused on helping to ensure access to affordable medicines to the American public. Programs like the AAM annual meeting provide platforms for sharing and exchanging information about various perspectives that are needed to further advance both the generic and biosimilar markets. If you have not previously attended the AAM annual meeting, maybe it’s a good time to consider sharing your insight along with other attendees at next year’s meeting in Amelia Island, Florida. Hopefully we will see you there!