Last Friday, The Biosimilars Council hosted a congressional briefing titled “Biosimilars: The Challenges and Promise of Patient Access.” AAM’s Craig Burton moderated a discussion with Molly Burich (Boehringer Ingelheim), Mark Fleury (American Cancer Society’s Cancer Action Network), Greg Gierer (America’s Health Insurance Plans) and Patrick Vallano (Mylan).
Although the speakers represented a variety of backgrounds and interests, they identified a few key principles as the U.S. biosimilars industry continues to mature:
- Biosimilars are safe and effective. Biosimilar medicines offer comparable safety and efficacy as their reference biologic counterparts. They do not have any clinically meaningful differences from their biologic counterparts and use the same mechanism of action. They go through the same rigorous FDA testing and review. (See “90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?”)
- A truly competitive biosimilars market will drive down drug prices and increase patient access to lifesaving medications. Just as generic pharmaceuticals make health care more accessible for patients, biosimilars promise substantial savings—over $54 billion over the next ten years – if the right policies are put in place to ensure a robust market, according to RAND Corporation.The policy and legal pathways for creating a robust market are realistic and achievable.
- Europe is far ahead of the U.S. In Europe, approximately 45 biosimilars have been approved across at least eight therapeutic classes. Although there are more than 60 biosimilar medicines in development in the U.S., only 9 have been approved to date, and only three are commercially available). According to IQVIA, patient access to both biosimilars and biologics has increased by as much as 100 percent in Europe as the result of biosimilar availability.
- Recent updates to biosimilars reimbursement in the Medicare Program are a step in the right direction, but threats remain. In recent months, the Centers for Medicare & Medicaid Services (CMS) and Congress have taken steps to place biosimilars on a level competitive playing field with their brand biologic counterparts in the Medicare program. These updates provide consistent and competitive reimbursement for biosimilars and are crucial in ensuring the creation of a strong market for these products. However, recent attempts to strip biosimilars of their “pass-through” status threaten this emerging market.
- Better education of patients and providers is needed. The promise of biosimilars will increasingly be realized as doctors, pharmacists and patients gain confidence in this relatively new concept. Insurance companies and patient advocate groups can also play a part in spreading information—and debunking misinformation. When generic medications entered the market in the 1980s, similar education was needed, and patients have saved nearly $1.7 trillion over the last ten years as a result of a safe, affordable generic alternative.
Events like the “Biosimilars: The Challenges and Promise of Patient Access” briefing will continue to shape perceptions about this exciting new pharmaceutical prospect. Please stay tuned for additional materials and briefings on this topic.