GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability
Tue, 22
Oct
2024
Posted by: Biocon Biologics
At the GRx+Biosims 2024 conference, panelists discussed the evolving regulatory landscape for biosimilar interchangeability, highlighting some of the remaining challenges regarding the label in the US and the path forward.1 The conference is taking place October 21 to 23 in Rockville, Maryland.
AI generated syringes | Image credit: Napat - stock.adobe.com
There are currently 13 FDA-approved interchangeable biosimilars: 2 insulin glargine, 3 adalimumab, 2 ranibizumab, 2 aflibercept, 1 ustekinumab, 2 denosumab, and 1 eculizumab. | Image credit: Napat - stock.adobe.com
Mustafa Unlu, PhD, JD, policy staff director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, the FDA, opened the discussion by explaining interchangeability, a US-specific designation rooted in early concerns over the unknown risks of biosimilars.
Author:
Biocon Biologics
Biocon Biologics