AMCP Partnership Forum: Biosimilars-policy, practice, and postmarketing surveillance to support treatment and coverage decisions.

Abstract

With the dual goals of identifying key actions that can support the further development and use of biosimilars in the United States and providing consistent and accurate messages about the value of biosimilars, AMCP held a virtual multidisciplinary stakeholder forum December 15-16, 2020. The participants, including payers, pharmacists, integrated delivery system leaders, health economists and analysts, academicians, patient advocates, pharmaceutical manufacturers, and other key decision makers, spent the 2 days (1) identifying challenges with biosimilar adoption within the US health care system; (2) determining clear and unbiased scientific messaging to support broader acceptance of biologics as valid therapeutic options and to facilitate faster time to biosimilar adoption; and (3) discussing needs and opportunities related to real-world evidence to help with adoption of biosimilars. Participants identified various challenges, including approval-related nuances and other regulatory considerations; general information about biosimilars and lack of consistent, positive messaging; clinical and administrative barriers; and economic complexities and variation. They also highlighted areas of opportunity, such as demystifying information and developing strong, positive messaging around biologics and biosimilars, and improving confidence in biosimilars by using tools such as education and real-world evidence, organizational strategies to ease biosimilar adoption, and updates to legislation and regulation to reduce barriers related to biosimilars. DISCLOSURES: This forum was sponsored by Amgen, the Association for Accessible Medicines, Boehringer Ingelheim, Fresenius Kabi, Johnson & Johnson, Novo Nordisk, Pfizer, Sandoz, and Takeda. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees, nor should they be construed as reflecting group consensus.