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IGBA Calls For ‘Streamlining’ Of Global Biosimilars Process

Points To ‘Limited Value’ Of Efficacy Data; Urges Renewed Education Efforts

 
• By Dave Wallace

The International Generic and Biosimilar medicines Association has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating health care professionals.

Efficacy_Sign
Comparative efficacy clinical data is largely surplus to requirements, the IGBA says • Source: Shutterstock

Global biosimilars development should be streamlined to take into account the latest science and years of market experience, the International Generic and Biosimilar medicines Association (IGBA) has urged in a new policy paper that advocates “changing the biosimilar development paradigm.”

In particular, the global off-patent body has pointed to the limited value of comparative efficacy clinical data, urging a greater emphasis on analytical data over clinical studies but acknowledging that...

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