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4. Defendant No.4, Mylan Pharmaceuticals Private Limited, a company incorporated under the Companies Act, with its registered office at Mumbai, is a subsidiary of defendant No.3 and pursuant to the co-development agreement between defendant No.2 and defendant No.3, has now launched a purported biosimilar version of Trastuzumab in India under the brand name HERTRAZ. Defendants No.1, 2, 3 and 4 are hereinafter (referred to as the "defendants").

5. Originally the suit was filed on account of imminent threat of the introduction of purported biosimilar version of plaintiff No.3's biological drug Trastuzumab, which is claimed to have been jointly developed by defendants No.2 and 3, under the brand names CANMAb (150 mg/440 mg) by defendant No.2 and HERTRAZ (150 mg/440 mg) by defendant No.1. CANMAb and HERTRAZ are together referred as the defendants' drugs. It was the plaintiffs' contention at that time that the defendants' drugs are, inter alia, being misrepresented as "Trastuzumab", "biosimilar Trastuzumab" and a biosimilar version of HERCEPTIN® without following due process in accordance with the Guidelines on Similar Biologics for the purpose of obtaining appropriate approvals.

9. It is averred in the plaint that under the procedure for the approval of new drugs by defendant No.1 in India, after NDAC (NEW DRUGS ADVISORY COMMITTEE ) has reviewed an application for a new drug and given its recommendation, on 18th October, 2013 it refers such application to a Technical Committee (the "TC"), along with its recommendation, for consideration. After the TC has endorsed the recommendation made by NDAC, it refers the application to the Apex Committee, and only after both TC and the Apex Committee have endorsed the recommendation of the NDAC, should defendant No.1 consider granting its approval to such application. This is usually a time consuming process and the consideration by the NDAC, the TC and the Apex Committee is unlikely to be completed in a short span of five days i.e. on 23rd October, 2013. The undue haste with which the approval was granted by defendant No.1 suggests that all factors relevant to the approval of a biosimilar drug under the Guidelines on Similar Biologies and under other internationally recognised standards were not taken into consideration at the time of granting such approval. It is also uncertain whether the TC and the Apex Committee were provided an opportunity to endorse the NDAC's recommendation before approval was granted by defendant No.1. In the European Union, while defendant No.3 started Phase III clinical trials for a purported biosimilar Trastuzumab on November 27, 2012, no approval for such purported biosimilar has been granted as yet. It is stated in the unamended plaint that the plaintiffs reserve their right to challenge the marketing authorisation granted by defendant No.1 to defendant No.2.

i) In the plaint it is mentioned that defendants No.2 to 4 have misrepresented the nature of the defendants' drugs as "biosimilar Trastuzumab", a Trastuzumab" and a "biosimilar version of HERCEPTIN®. Such misrepresentations are likely to deceive the patients using Trastuzumab regarding the efficacy and safety of the defendants' drugs as "Biosimilars"

are biological products that are similar to the innovator biopharmaceutical product can only be similar to the innovator biopharmaceutical product; it cannot be a generic equivalent of the innovator biopharmaceutical product. Although biosimilars are gaining popularity in Indian and international markets, biosimilars are not in the nature of generic drugs. Rather these are unique molecules for which only limited data is available at the time of approval, and as such, the concerns and risks associated with the long term safety, efficacy and immunogenicity of biosimilars are significantly higher compared to those associated with a generic drug.

iv) The defendants' drugs have not been tested against the standards set forth in the Guidelines on Similar Biologies and the marketing authorisation for Bmab-200 is not issued under the Guidelines on Similar Biologies. Defendants No.2 to 4 have falsely and wrongly represented the defendants' drugs as the first biosimilar version of Trastuzumab and a biosimilar version of HERCEPTIN® in various press statements. Further, even the marketing and promotional material for the defendants' drugs by defendant No.2 represent such drugs as "Trastuzumab for Injection" and "biosimilar Trastuzumab".