On December 3, 2021 Global pharma major, Lupin Limited (Lupin) reported that they have entered into an exclusive distribution and marketing agreement with Biomm SA in Brazil (Press release, Lupin, DEC 3, 2021, View Source [SID1234596434]). Under the terms of agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.

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Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.