New Delhi|HL Correspondent
The manufacture and sale of ‘Trastuzumab’ is allowed by High Court of Delhi on Monday with certain constraints.
Trastuzumab is a drug used in the treatment of breast cancer and a product by Biocon and Reliance Life Sciences.
While delivering the order on the case of Swiss pharmaceutical firm Roche against Biocon and Reliance, Justice Manmohan Singh said that there may be need to follow tough guidelines framed in 2012 for getting regulatory approvals by biosimilars (non-originator biological products).
The judgement allows sale and manufacture of the drug in terms of packaging and labeling and for the regulatory process. Even as the full implication of the order is still being studied, It could prove to be a challenge for the biosimilar industry, industry experts say.
Trastuzumab is an off-patent, anti-cancer drug marketed by Roche as herceptin. Biocon introduced a biosimilar of herceptin, CANMAb in 2014, at a fraction of the global price. The innovator Roche’s MRP is around Rs 75,000 per 440mg, while Biocon’s is around 25% lower at Rs 57,500, and Zydus launched the product recently at Rs 65,000.
