Lupin signs agreement for biosimilar Pegfilgrastim in Brazil

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Lupin Limited has signed an exclusive distribution and marketing agreement with for biosimilar in Brazil.

The Indian pharma company had earlier secured the US Food and Drugs Administration (FDA) acceptance of the biologics license application (BLA) for its proposed biosimilar to (pegfilgrastim) via a filing using the 3Sl(k) pathway.

See also  FDA concludes inspection at Lupin Bioresearch Centre in Pune

Pegfilgrastim is approved for the reduction of the duration of neutropenia as well as the incidents of in patients undergoing chemotherapy.


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