Tag: EMA
GENERAL Biocon Arm Secures Positive EMA Opinion For Pertuzumab Biosimilar

Biocon Biologics Ltd, a wholly-owned subsidiary of Biocon Ltd, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation for its Pertuzumab biosimilar, Pebrilzo, for the treatment of HER2-positive breast cancer. The product, available as a 420 mg concentrate solution for […]

CW Bureau · Sep 21, 2026
GENERAL Shilpa Biologicals Commissions ADC Drug Substance Manufacturing Unit

Shilpa Biologicals Ltd, a material subsidiary of Shilpa Medicare Ltd, has commissioned a Good Manufacturing Practice (GMP)-compliant Antibody-Drug Conjugate (ADC) manufacturing facility designed to meet global regulatory standards. The facility is fully operational, with GMP qualification protocols currently underway, paving the way for commercial-scale operations. Integrated ADC capabilities With the commissioning of the facility, Shilpa […]

CW Bureau · Jun 24, 2026