The US Food and Drug Administration (FDA) is seeking public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication (Program) for original biologics license applications (BLAs). The program is part of the FDA’s commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA).
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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
- 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
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
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Biosimilars
News
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- FDA approves interchangeable adalimumab biosimilar Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Research
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
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