WebPegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. This product is the first biosimilar application to be filed by Lupin in the US. WebFeb 1, 2024 · Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy. Lupin had earlier received the USFDA acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim).
Biosimilar Pipeline Quarterly Update: June 2024 - Prime …
WebJun 4, 2024 · The FDA has accepted the biologics license application (BLA) for a proposed biosimilar for pegfilgrastim (Neulasta), which had been developed by Lupin Limited. 1 … WebNov 2, 2024 · Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing. famous people in peru\u0027s history
Lupin announces U.S. FDA acceptance for Pegfilgrastim Biosimilar
WebPegfilgrastim has estimated annual sales of $3.66 billion in the U.S. (IQVIA MAT December 2024). Commenting on the development, Vinita Gupta, CEO of Lupin said, "FDA's acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need. WebNov 29, 2024 · Lupin has now announced plans to take the drug to the US market, alongside a biosimilar of pegfilgrastim, which stimulates the production of white blood … WebMar 20, 2024 · Drug: Lupin's Pegfilgrastim Drug: Neulasta® Detailed Description An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupin's Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in … famous people in pakistan