Blogs

The European Medicines Agency (EMA) this week published a concept paper on its proposed revisions to the agency’s guideline on biosimilars and is seeking public comment. EMA will accept comments until 31 December 2011, and the final revised guideline is expected to be published in 2012. The EU’s regulatory framework for biosimilars is more advanced than those of many of its global counterparts, such as the US Food and Drug Administration, which is currently in the process of crafting the regulatory pathway for biosimilars.

Read more:

• EMA goes one step forward about biosimilars (Biosimilar News)
• European Medicines Agency invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines (EMA press release)
• Concept paper on the revision of the guideline on similar biological medicinal products (EMA concept paper)