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Lupin application for Pegfilgrastim biosimilar accepted by USFDA
Mumbai: Global pharma major, Lupin Limited, has recently announced that the USFDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.
Read also: Lupin gets USD 50 million milestone payment from Boehringer Ingelheim for anti-cancer drug
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
Read also: Eli Lilly ink licensing pact with Sun Pharma, Cipla, Lupin to expedite COVID drug Baricitinib
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751