South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.
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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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Biosimilars
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- 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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