Biocon arm gets Japanese regulatory nod for pegfilgrastim biosimilar

OrangeNews9

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.

“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 in a statement.

Biocon is India’s leading biopharma company. It is fully integrated and delivers biopharma solutions ranging from discovery to development and commercialisation. It has diversified revenue streams covering biosimilars, contract research, small molecules and APIs.

The company had reported 355% jump in consolidated net profit to Rs 141 crore in Q1 FY27 from Rs 31 crore in Q1 FY26. Revenue from operations rose by 10% year-on-year (YoY) to Rs 4,336 crore during the period under review.

The scrip shed 0.28% to currently trade at Rs 408.85 on the BSE.

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