On February 1, 2022 Global pharma major, Lupin Limited (Lupin) reported that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries; Pharma International Company and Med City Pharmaceutical Industries (Press release, Lupin, FEB 1, 2022, View Source [SID1234607548]). Under the terms of Agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim Drug Product in certain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

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Lupin had earlier received the U.S. FDA acceptance for review 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.