The Indian Ministry of Health is planning to revise its guidelines for approving ‘similar biologics’. The ministry aims to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars.
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Generics
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- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Research
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- Generic medications in the Lebanese community: understanding and public perception
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Biosimilars
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- EC approves eight biosimilars, six more await final authorization
- EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma
- FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo
- Canada approves pegfilgrastim biosimilar Pexegra
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