Lupin Limited announced that the company has entered into a License, Supply, and Technology Sharing agreement with Axantia Holding (Axantia). Under the said agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim Drug products in certain GCC Countries including Jordan, Lebanon, Iraq, Sudan, Algeria, and Libya, and some territories including Saudi Arabia.
Lupin had earlier also bagged the US FDA approval for review of Biologics License Application (BLA) for its proposed biosimilar to Neulasta® (pegfilgrastim) through a filing using the 351(k) pathway.
Pegfilgrastim is directed to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company manufactures and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs targeting over 100 markets in the U.S., India, South Africa, and across the Europe, Asia Pacific (APAC), Middle East regions and Latin America (LATAM).
Lupin operates 15 manufacturing sites, 7 research centers, and engages more than 20,000 talent heads globally.
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