Biocon Ltd on Tuesday announced that its subsidiary, Biocon Biologics, has secured marketing authorisation for its pegfilgrastim biosimilar from Japan’s Ministry of Health, Labour and Welfare (MHLW).
The biosimilar is a supportive cancer-care treatment used to reduce the risk of infections in patients undergoing chemotherapy. It is a biosimilar version of Neulasta.
Biocon Biologics developed and manufactured the product, while Global Regulatory Partners Japan will act as the marketing authorisation holder in Japan on behalf of the company, Biocon said in a regulatory filing.