Global Industry Hails Bioequivalence Progress

ICH Working Group Starts Devising Plan

 
• By Aidan Fry
  
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For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.

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Global development of immediate-release oral solid generics could be aided by bioequivalence guidance being developed by the ICH • Source: Shutterstock

The formal adoption by the International Council for Harmonization’s general assembly of a new topic on bioequivalence for immediate-release solid oral dosage forms has been welcomed by the International Generic and Biosimilar Medicines Association. During its most recent meeting held in Singapore last month, the ICH assembly agreed a concept paper outline for the M13 bioequivalence topic and decided to establish “without delay” a new working group to work on finalizing the concept paper and devise a business plan.

“This is the first topic since the ICH reorganization in 2016 that is specifically focused on the generic medicines industry,”...

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