As drug manufacturers await guidance on a biosimilar approval pathway in the US, the debate goes on as to how high the bar will be set for the FDA to designate a biosimilar as interchangeable. In one critical area of the law that outlines biosimilar regulations, Congress outlines the difference between biosimilarity and interchangeability with respect to biosimilars and innovative biologicals, but the FDA has yet to define the difference.
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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
- 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
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
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Biosimilars
News
- FDA approves third ustekinumab biosimilar Pyzchiva
- FDA approves first eculizumab biosimilar Bkemv for two rare diseases
- EMA recommends approval of biosimilar bevacizumab Avzivi
- EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva
Research
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
- Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma
- Tocilizumab and pembrolizumab biosimilar advances for Korean firms
- Unveiling key clinical findings for denosumab biosimilar candidates
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