This webinar on ‘INTERCHANGEABILITY DESIGNATION FOR BIOSIMILARS’ is particularly relevant in light of the November 6th proposed rule by Centers for Medicare and Medicaid Services (CMS) to permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biological medicines now used to treat many chronic conditions, such as rheumatoid arthritis, Crohn’s disease, and cancer. The policy change represents a stark departure from the perspectives of the US medical community and patient advocacy organizations. It marks a shift from a decade of state-level policymaking and contradicts CMS’ recent assurances.

In the ever-evolving landscape of biopharmaceuticals, biosimilars play a pivotal role in expanding patient access to high-quality, cost-effective treatments. Achieving interchangeability status is a crucial milestone for enhancing uptake whilst safeguarding patient safety.

Patients often try different products for years before finding the most effective one to stabilize their condition. Both doctors and patients are reluctant to change medication unnecessarily, as it risks compromising the progress made. 

US state laws allow pharmacies to substitute ‘interchangeable biosimilars’, provided the manufacturer has submitted additional safety and efficacy data to the US Food and Drug Administration (FDA). These laws, enacted over the past decade with support from physician societies and patient advocacy organizations, require assurances that only ‘interchangeable biosimilars’ can be substituted without physician approval.

The additional data that the ‘interchangeable biosimilar’ carries boosts physician and patient confidence. Any change in the interchangeability designation of a biosimilar will undermine the level of confidence built up over the past years, the efforts made in passing state laws, damage the education spent in the community of healthcare providers, and distort the concept of interchangeability.

In this webinar, we will explore key scientific factors essential to secure interchangeability designation in biosimilars. Expert speakers will discuss challenges, opportunities, and implications surrounding the ongoing development involving interchangeable biosimilars, covering topics like the CMS Part D proposed rule, the HELP and Lee bill, and the rationale for pursuing interchangeable designation. The webinar will address challenges and patient concerns, emphasizing patient engagement to safeguard interchangeability status and improve patient protection.  

Moderator: Steven Stranne, MD, JD, Partner, Foley Hoag LLP, USA

SPEAKERS/PANELISTS:

Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines
Ralph McKibbin, MD, FACP, FACG, AGAF, Past President of the Pennsylvania Society of Gastroenterology and the Digestive Disease National Coalition, USA
Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Ohio State University, USA
Andrew Spiegel, Esq, Executive Director, Global Colon Cancer Association 

Download the full programme!

Online event hosted by the Alliance for Safe Biologic Medicines in collaboration with GENERICS AND BIOSIMILARS INITIATIVE.