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Biosimilars Report Bolsters IGBA’s Calls To Streamline Development Process

IPRP Biosimilars Working Group Urges Reassessment Of Comparative Efficacy Studies

 
• By Dave Wallace

The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

IGBA logo
The IGBA wants a more streamlined approach to biosimilar development • Source: IGBA

A fresh call to international regulators urging the streamlining of biosimilar development and registration processes has been voiced by the International Generic and Biosimilar Medicines Association, in the wake of recent recommendations from the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

In a report summarizing a workshop on increasing the efficiency of biosimilar development programs and re-evaluating the need for comparative clinical efficacy studies for biosimilars, the IPRP’s BWG highlighted...

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