Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.
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- US generics launch and approval for Dr Reddy’s and Lupin
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- South Korean companies to make generic Bridion and COVID-19 drugs
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Biosimilars
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- EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
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- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
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