Indian court issues injunction on Biocon, Mylan's Herceptin biosimilars after challenge by Roche

The Delhi High Court issued an injunction preventing Biocon and Mylan from comparing their biosimilar versions of Roche's breast cancer drug Herceptin (trastuzumab) to the originator product after the Swiss company filed a lawsuit against the drugmakers and the Drugs Controller General of India (DCGI). The DCGI approved the drugs under the name CANMAb by Biocon and as Hertraz by co-development partner Mylan in November last year.

Biocon recently said that it planned to launch CANMAb around the first week of February, with the product being priced at about a 25-percent discount to the cost of Herceptin in the country. However, Roche argued that Biocon and Mylan's drugs are being misrepresented as "biosimilar trastuzumab" and a "biosimilar version of Herceptin." The Swiss drugmaker claimed that Biocon could not have followed the "due process" defined in India's 2012 guidelines on the approval of biosimilar drugs, as "approvals could not have been granted in such a short period in view of the long procedure."

According to Roche, there is no public record available in India's clinical trial registry or elsewhere to show that Biocon and Mylan conducted Phase I or II studies for the compounds. As a result, the Delhi High Court issued an injunction, ruling that Biocon and Mylan were "not entitled to introduce or launch the drug without the requisite approvals." Roche's lawsuit was also launched against the DCGI for granting permission to Biocon and Mylan to launch their CANMAb and Hertraz products. The next hearing on the matter is scheduled for February 28.

In a statement provided to FirstWord, Roche noted that the legal action is "not a patent litigation," but seeks to determine whether CANMAb and Hertraz "have demonstrated comparable efficacy and safety to [Herceptin], and have been approved as biosimilar products." The company said that "as far as we are aware, the Indian regulatory authorities have approved [the] products as trastuzumab, as per their regulatory process, but it is unclear if the products meet the criteria for biosimilar products." Roche added that while the DCGI is named in the lawsuit, it has "not sought to challenge the approvals."

In response, Biocon said "it is an extremely shocking, but not unexpected development especially as Roche had decided not to pursue Indian patents" for Herceptin. The Indian drugmaker suggested that the lawsuit "is an attempt by Roche to protect their market monopoly," adding that CANMAb and Hertraz "adhere to stringent quality standards and have been developed on the basis of applicable biosimilar guidelines." Biocon indicated that "we are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand."

In a separate statement provided to FirstWord, Mylan argued that Roche's proceedings are "aimed at hindering access to trastuzumab," adding "we do not believe that the injunction will prevent us from manufacturing and selling Hertraz."

For related analysis, see ViewPoints: Biosimilar Herceptin approved in India, but regulatory requirements someway below bar set by Europe.

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