News

Article

FDA Releases Draft Guidance on Biosimilarity

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA has released draft guidance on the use of clinical pharmacology studies to determine if a proposed therapeutic biologic product is biosimilar to its reference product.  The guidance pertains to products that require pharmacokinetic and pharmacodynamics data to demonstrate biosimilarity. The guidance addresses clinical pharmacology testing for biosimilar products, developing an appropriate clinical pharmacology database, and designing clinical trials.  

The draft guidance is one in a series by FDA for the implementation of the Biologics Price Competition Act of 2009. FDA intends the guidance to “assist sponsors in designing clinical pharmacology studies that can support an application submitted under section 351(k) of the Public Health Service Act (PHS Act).” According to FDA, the guidance may also be helpful for the development of certain products under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Source: FDA.gov

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner