In a Federal Register notice published on 15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeability of biosimilars with their reference biologicals. This change came after the agency received requests for an extension.
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Generics
News
- 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
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- FDA approves Hadlima and Otulfi as interchangeable biosimilars
- EC approves three biosimilars, 14 more await final authorization
- FDA approves denosumab biosimilars Stoboclo and Osenvelt
- EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
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