Lupin yesterday entered into a licence-, supply- and technology-sharing agreement with Axantia Holding. Under the terms of the 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, a company statement notified.
Lupin had earlier received the US Food and Drug Administration (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, added the statement.