Biocon Gets CDSCO Panel Nod to Market Trastuzumab PGS in India

“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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