Global Industry Hails Bioequivalence Progress
ICH Working Group Starts Devising Plan
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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Hanan Sboul, secretary general of the Jordanian Association of Pharmaceutical Manufacturers, has been named as chair of the International Generic and Biosimilar medicines Association. She takes over from Jim Keon, president of the Canadian Generic Pharmaceutical Association.
The ICH has published a reflection paper on harmonizing technical and scientific standards for generics that envisages initially developing guidelines on bioequivalence standards for non-complex oral dosage forms, followed by guidance on more complex dosage forms or products. A discussion group will also be established to identify opportunities to include generics in other ICH guidelines.
Global generics and biosimilars industry representatives have celebrated a “historical moment for our industry” after the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) elected the International Generic and Biosimilar Medicines Association (IGBA) as a member of its management committee.