Biocon Biologics, a wholly-owned subsidiary of Biocon, has received marketing approval for its pegfilgrastim biosimilar from Japan’s Ministry of Health, Labour and Welfare (MHLW).
The product, a biosimilar of Amgen’s Neulasta (pegfilgrastim), was developed and manufactured by Biocon Biologics, with Global Regulatory Partners Japan (GRP Japan) serving as the Marketing Authorisation Holder on behalf of Biocon Biologics. Sandoz K.K. will exclusively promote, sell and distribute the product in Japan.
Pegfilgrastim is used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a high risk of febrile neutropenia.
Neulasta and its biosimilar versions are administered by subcutaneous injection and supplied as single-dose prefilled syringes containing 6 mg/0.6 mL. Some versions are also available as autoinjectors or single-dose vials.
Biocon said the approval further strengthens its portfolio of biosimilar products in Japan and reaffirms the company’s commitment to increasing patient access to high-quality and affordable medications globally.
Biocon Biologics has a broad pipeline of 20 biosimilar molecules spanning insulins, monoclonal antibodies and conjugated recombinant proteins, of which 10 are commercialised products.
Its commercialized products include trastuzumab, adalimumab, rh-insulin, pegfilgrastim, etanercept, insulin glargine, bevacizumab, ustekinumab, insulin aspart and aflibercept.
