Have not challenged DCGI approvals: Roche

Swiss pharma firm Roche's Indian arm on Friday said it has not challenged Drug Controller General of India's (DCGI) approval in a case where it has sought an injunction against two pharma companies - the Bangalore based Biocon and US-based Mylan. The two companies have co-developed biosimilar of the drug Herceptin, which treats certain types of breast cancers. Formerly, Roche held the patent for Herceptin, but unexpectedly gave it up last year.
 
"We have named the Drug Controller General of India (DCGI) as a party but our actions have not sought to challenge the approvals," a spokesperson of the Swiss pharma major Roche has clarified in response to an email from Business Today.
 
Business Today had written to Roche seeking to know the grounds on which the company was reportedly suing the regulator.
 
"Roche has filed and secured an injunction against Biocon and Mylan. The injunction prevents the companies from comparing their products to Herceptin," the Roche spokesperson said.
 
"This legal action is not a patent litigation," the Roche spokesperson clarified. "Rather, in taking this action we are seeking to clarify if Biocon and Mylan products have demonstrated comparable efficacy and safety to our innovator product trastuzumab (currently marketed in India as Herclon), and have been approved as biosimilar products. We have taken this action because, 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." This, the spokesperson says, "is particularly important in the case of Biocon and Mylan Inc.'s products, as there is very limited information in the public domain and we believe it is important to ensure that patients and physicians can make informed decisions."
 
On the regulatory approvals:  "As far as we are aware, the Indian regulatory authorities have approved Biocon and Mylan Inc.'s products as trastuzumab, as per their regulatory process, but it is unclear if the products meet the criteria for biosimilar products. We have taken this action because we would like to get clarity on this point."
 
Earlier, DCGI G N Singh said the regulator is so far unaware of any move against it by Swiss pharma major Roche's Indian arm.
 
The DCGI has always done things as per the regulations prevailing in the country and keeping in mind the best interests of the people of India , says Singh. But he adds that since the matter appears to be sub-judice, he would not comment on it specifically. In addition, he noted that the DCGI also follows the World Health Organisation (WHO)'s principle that risks and benefits relating to the launch of new medicines have to be viewed keeping in mind the issues of affordability of essential medicines. "We want to see that essential medicines are made available to the Indian people at the appropriate and affordable price," he said.

Meanwhile, a spokesperson for Biocon says: "It is an extremely shocking, but not unexpected development especially as Roche had decided not to pursue Indian patents for their breast cancer drug. 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 & 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. "

*The story has been updated with responses from Roche and Biocon and the headline changed.