Generic drugmaker Mylan and its partner Biocon have been successfully sued by Roche for failing to carry out sufficient clinical trials on 'similar biologics’ of the breast cancer blockbuster Herceptin (trastuzumab). Mylan and Biocon had recently announced plans to launch their 'similar biologics’ in India.
Trastuzumab, a monoclonal antibody that interferes with the HER2/neu receptor, is marketed by Roche as Herceptin. It is used to treat certain breast cancers. In 2012, Herceptin made worldwide sales of US$6.4 billion for the Switzerland-based pharma giant.
In 2013, Roche abandoned its patent for Herceptin in India, opening the market to 'similar biologics’. The move may have been in response to the Indian Government reportedly planning to issue a compulsory licence for Herceptin once a 'similar biologics’ version of the drug was available. The price of the originator blockbuster had put it out of reach for most of the population of India.
Bangalore-based Biocon was expected to start selling its 'similar biologics’, Canmab, for between 25% and 35% of the price of Herceptin. Mylan launched its 'similar biologics’, Hertraz, on 3 February 2014.
The Delhi High Court has now restrained Biocon and Mylan from claiming that their cheaper breast cancer drugs are 'biosimilar’ versions of the originator.
'As the holder of the Herceptin trademark we have a duty to ensure that if a company claims its product is a biosimilar of or similar to our innovator product trastuzumab, that this really is the case,’ a Roche spokesperson told the Indian business paperLiveMint.
Roche is also suing the Drug Controller General of India (DCGI), alleging that the regulator had not followed due diligence and potentially used Roche data when considering the application. The case is due in court on 28 February 2014.
Biocon and Mylan may appeal the decision in a higher court, since the cost of conducting a full set of clinical trials will be expensive and could delay market entry.
'It is an extremely shocking, but not unexpected development,’ reads a statement on the Biocon website. 'This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab. Canmab and Hertraz co-developed by Biocon and Mylan are world-class products that adhere to stringent quality standards and have been developed on the basis of applicable biosimilar guidelines. Biocon and Mylan are committed to affordability and access and are driven by their purpose of expanding the pool of patients that can afford trastuzumab. We are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand.’
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