Indian drugmaker Lupin Limited (BSE: 500257) today revealed it has entered into a license, supply and technology sharing agreement with Axantia Holding for the distribution of its Pegfilgrastim, a biosimilar of Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim).
Axantia is a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries - Pharma International Company and Med City Pharmaceutical Industries. 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.
Lupin had earlier received the US Food and Drug Administration acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta through a filing using the 351(k) pathway.
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