The Delhi High Court on Monday gave approval to Indian biopharma companies Biocon and Reliance Life Sciences for the manufacture and sale of breast cancer drug trastuzumab, which is originally made by the Swiss drug-maker Roche.
The Delhi High Court's approval has however come with instructions asking the companies to follow stringent regulatory guidelines that were issued in 2012 for the manufacture of biosmiliars (non-original biological drugs), the Times of India reported.
Reliance Life Sciences was earlier prohibited from manufacturing the anti-cancer drug although similar drugs from two Indian companies — Biocon and Mylan — were already available in the market.
Roche had reportedly sued Biocon and Mylan alleging that the two companies had used product inserts that compare their products with Roche's brand.
Even as the Indian biopharma companies have now been allowed to manufacture and sell the cancer drug, restrictions have been imposed on the drug packaging and labelling.
"This is the first judgment on biosimilars in India. The country's strength in generics should also be replicated in biosimilars. This judgement questions the regulatory process of approvals of biosimilars in India, and could be a challenge for the government and the industry. The time has come for the government to take a policy decision for approval of biosimilars in the country," Prathiba M Singh, senior advocate representing Biocon, was quoted as saying by TOI.
Meanwhile, Reliance Life Sciences was quoted by TOI as saying that the company would soon launch its anti-cancer drug after the Delhi High Court approval.
Trastuzumab is an off-patent anti-cancer drug marketed by Roche under the brand name herceptin. Biocon introduced a cheaper version of herceptin in 2014 called CANMAb.
Roche sells the breast cancer drug for Rs. 75,000 per 440mg, whereas Biocon's sells the same drug at Rs. 57,500.