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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)

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 away with the need for comparative efficacy trials for biosimilars in most cases, and more recently the European Medicines Agency has published a landmark draft reflection paper on streamlining development and assessment.

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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