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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

Representatives From European, US, Japanese And Saudi Agencies Talk Streamlining

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

A panel of international regulators discussed convergence around biosimilar streamlining (Medicines for Europe) (Medicines for Europe)
Key Takeaways
  • Regulators from around the world shared their thoughts on the need for regulatory convergence when it comes to developing biosimilars.
  • The US FDA’s Sarah Yim said there was a host of products that could have biosimilars but “aren’t getting them because it’s too expensive to develop a biosimilar to them.”
  • The EMA’s René Anour said that 20 years of regulatory experience had shown that clinical trials do not add relevant information regarding comparability to what has been done on the quality and PK analysis.
  • Ryosuke Kuribayashi, of Japan’s PMDA, pledged to “actively share in the global trend of biosimilar development,” and “share the evolving new regulatory approach with various stakeholders in Japan.
  • The Saudi FDA’s Ali Alhomaidan said the SFDA had updated its own guidelines to place more emphasis on analytical data and to clarify when comparative efficacy studies would be required.

Successes are increasingly being seen in the area of regulatory streamlining for biosimilars. Individual markets such as the UK have signalled a willingness to do...

But biosimilars development is a global enterprise, with products developed not just for one individual market, or even a large single region like the EU. This means that while local...

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