Biosimilars continue to be the focus of policymaker and public attention, and the Biosimilars Council has been active on the regulatory, legislative and educational fronts.
Earlier this year, the Council worked with IQVIA to show how PBM schemes to control biosimilar Humira cost patients and employers $6 billion in potential savings last year. Last week, we built on that work with a new report showing how leading PBMs continue to manipulate biosimilar competition to their own profit, and at the expense of patients. In short, the major PBMs continue to prefer the high-priced brand despite biosimilar alternatives with discounts of more than 80 percent. To make things worse, the analysis shows that PBM rebate strategies not only delay patient adoption of lower-price biosimilars, but also shift patients to new, higher-priced medicines. The Council continues to call on Congress to enact legislation to rein in such PBM abuses—unchecked, these PBM strategies to profit from fees and rebates based on high list prices will continue to drive coverage decisions to the detriment of patients, health plans and community pharmacies.
But the Council is also working to get biosimilars to the market faster. Earlier this summer, we released an important paper calling for more efficient, streamlined regulatory pathways for biosimilars. Streamlining the approval process for biosimilars will improve the process for patients, drug manufacturers, and the FDA. In particular, eliminating unnecessary clinical efficacy studies and establishing global regulatory comparators to support demonstration of biosimilarity would allow for the elimination of unnecessary regulatory requirements when data demonstrates no clinical meaningful difference between the biosimilar and its biologic reference product. Keep an eye out for additional updates on this critical issue.
Speaking of the FDA, the Council applauds the Agency for its continued work to fight misinformation about the safety and efficacy of biosimilars. Indeed, misinformation has been a significant impediment to use of safe and effective lower-priced biosimilars, and we believe that revised guidance will help ensure that sponsors engage in truthful and non-misleading communications regarding biosimilars, including interchangeable biosimilars and their reference products. Combatting misinformation about biosimilars has long been a priority for the Council, and we recently released a blog speaking to the harm that such misinformation causes patients, undermining the FDA by sowing unnecessary doubt around their gold-standard approval process. You can read that full blog here.
To help providers better understand biosimilars and interchangeable biologics, the Council is proud to have partnered with the American Pharmacists Association to develop two new resources—an FAQ and an explainer paper called “Focus On: Interchangeable Biosimilars”. These resources will help educate pharmacists and pharmacy students about interchangeable biosimilars and promote increased access and availability for patients. Equipping pharmacists with accurate information about biosimilars ensures that pharmacists can help patients benefit from lower-cost biosimilars, and the Council is committed to amplifying these important educational resources to ensure that pharmacists can excel in educating consumers about biosimilar medicines.
Further underscoring the need to for reliable biosimilars education, the FDA released an important resource highlighting nine important facts around biosimilars and interchangeable biosimilars. This easy-to-access tool is essential for those wanting to learn more about this important topic, and it follows a draft FDA guidance describing considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. The Biosimilars Council applauded the FDA for the updated draft guidance, highlighting that biosimilars – with and without an interchangeability designation – are safe and effective, and lower-price options for patients.
Finally, just before breaking for the summer recess, the Senate unanimously passed the Affordable Prescriptions for Patients Act led by Senator Cornyn (R-TX) and Senator Blumenthal (D-CT). This important legislation is a critical step in curbing patent abuse and will help increase competition and access for biosimilars. We encourage the House to take up this legislation and for Congress to continue working to help lower costs for patients.
As the legislative session takes back up in the Fall, the Council will continue to promote the value of and challenges facing biosimilars so that patients can benefit more from these lower-cost medicines. Stay tuned for our preview of the fall legislative session in our next Biosimilar Bulletin, as well as exciting speaker updates and panel previews for our upcoming GRx+Biosims conference, taking place October 20–23 in Rockville, MD. Don’t forget to register before you head out on your summer vacation!
