Biosimilars Regulatory Roundup for November 2022—Podcast Edition

An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.

On this episode of Not So Different, we review all the big biosimilar policy news from July, including discussions regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.