Biocon Gets CDSCO Panel Nod to Market Trastuzumab PGS in India
New Delhi: The Subject Expert Committee (SEC) on Oncology and Hematology, functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended granting permission to Biocon Biologics Ltd to manufacture and market Trastuzumab lyophilized powder for injection (PGS formulation) in India, subject to a post-marketing surveillance (PMS) study.
The recommendation was made during the committee’s 15th meeting held on 6th May 2025 at CDSCO headquarters in New Delhi.
Biocon presented its proposal seeking approval for Trastuzumab lyophilized powder for injection 150 mg and 440 mg vials (PGS formulation) for the treatment of Adjuvant Breast Cancer, Metastatic Breast Cancer, and Metastatic Gastric Cancer. The application was backed by results from a global clinical trial including Indian patients.
The SEC took note that the formulation is already approved internationally:
“The committee noted that Trastuzumab lyophilized powder for injection 150mg vial and 440 mg vial (PGS formulation) is approved in 90 countries including USA, EU, Canada, Australia, Singapore etc.”
It also acknowledged that while Trastuzumab 150 mg/440 mg (RPF formulation) is currently approved in India for domestic use, the PGS formulation was previously approved only for export.
Following detailed deliberation, the SEC recommended approval for the Indian market, but with a specific regulatory requirement:
“The committee recommended for grant of permission to manufacture and market Trastuzumab lyophilized powder for injection 150mg vial and 440 mg vial (PGS formulation) with the condition to conduct PMS study in India.”
“Accordingly, the firm shall submit the protocol to conduct PMS study within 03 months of approval.”
Trastuzumab, also known by the brand name Herceptin, is a targeted monoclonal antibody therapy used to treat HER2-positive breast and gastric cancers. It works by binding to the HER2 protein on cancer cells, thereby inhibiting growth signals and marking the cells for destruction by the immune system. It is commonly administered in combination with chemotherapy.
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