By: IPP Bureau
Last updated : December 05, 2021 3:10 pm
Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar
Lupin has entered into an exclusive distribution and marketing agreement with Biomm SA in Brazil. Under the terms of the agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.
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.