New Delhi, Biocon Ltd on Tuesday said its arm Biocon Biologics has received marketing approval for its pegfilgrastim biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW).The pegfilgrastim biosimilar is a cancer supportive care medicine used to prevent infections after chemotherapy.The product, a biosimilar to Neulasta, is developed and manufactured by Biocon Biologics Ltd, parent entity of Biocon Biologics UK PLC, with Global Regulatory Partners Japan serving as the marketing authorisation holder on behalf of Biocon, the company said in a regulatory filing.Sandoz KK will exclusively promote, sell, and distribute the product in Japan, it added.This approval further strengthens Biocon's portfolio of biosimilar products in Japan and reaffirms the company's commitment to increasing patient access to high-quality and affordable medications globally, the company said.
Biocon arm gets Japan nod for cancer drug pegfilgrastim biosimilar
In a significant advancement, Biocon Biologics has gained marketing approval for its pegfilgrastim biosimilar in Japan. This vital cancer supportive care drug is designed to mitigate infection risks following chemotherapy. Developed as a rival to Neulasta, Sandoz KK will handle its exclusive promotion and distribution. This approval marks a pivotal step in expanding Biocon's biosimilar range and improving patient accessibility worldwide.
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