Approval Alert: Intas Pharmaceutical Receives Approval to Manufacture and Market Biosimilar Pertuzumab in India

India’s Medical Dialogues reports that Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug pertuzumab, biosimilar to Roche’s Perjeta®, for HER2-positive metastatic breast cancer.  This approval is subject to Intas conducting Phase IV studies in India and submitting the Phase IV study protocol within three months of the grant of marketing authorisation of the drug.