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6.6 Defendants No.1 and 2 framed the Biosimilar Guidelines which came into effect on September 15, 2012, in order to provide a legal framework for evaluation and approval of biosimilar drugs in India. The Biosimilar Guidelines have introduced a regime for comparative testing between a purported biosimilar drug and the innovator biological drug. The Biosimilar Guidelines were released publicly at the Biotechnology Industry Association conference in Boston in June, 2012 to show India's compliance with international practices and the applicable regime of the World Health Organisation. At this conference, defendants No.1 and 2 made public statements indicating that they will implement and follow the Biosimilar Guidelines in India.

7. It is averred in the plaint that after the issuance of the Biosimilar Guidelines, all applications for manufacturing and marketing authorisation of similar biologies in India are required to be evaluated on the basis of the standards set forth in the Biosimilar Guidelines read with the Drugs Act and the Drugs Rules. The Drugs Act, the Drugs Rules and the Biosimilar Guidelines ensure that adequate tests are conducted prior to the approval of biosimilars and it is essential that they are followed at all stages of product development, testing and approval of a purported biosimilar drug to ensure the safety of patients. A thorough consideration should be given to the scientific basis of the study design, objectives, study end points, sample size and study duration of the applicant's product before approval is granted to a biosimilar drug and only products which have been approved under the Biosimilar Guidelines read with the Drugs Act and the Drugs Rules should be allowed to be represented as biosimilar products.

c) The letter to defendant No. 1 dated July 12, 2010 reflects that defendant No.3 has also not conducted comparative pre-clinical studies with the plaintiffs' Trastuzumab as required under Clause 7 of the Biosimilar Guidelines. In the absence of comparative pre-clinical studies, TrastuRel cannot be approved by defendant No.1 as a biosimilar version of the plaintiffs' Trastuzumab.

d) Phases I and II of clinical trials: Rule 122DA of the Drugs Rules mandates that all three phases of human clinical trials be conducted for a 'new drug' (as defined under Rule 122E of the Drugs Rules). Paragraph 2(7)(i) of Schedule Y of the Drugs Rules further provides that clinical trials should be conducted in a sequential manner, i.e., the data generated in Phase I clinical trials should form the basis of Phase II clinical trials and similarly, the data generated in Phase I and Phase II of the clinical trials should form the basis of Phase III clinical trials. Also, under paragraph l(l)(iv) of Schedule Y of the Drugs Rules, for new drug substances discovered in India, clinical trials are required to be carried out in India from Phase 1 onwards. Further, Clause 8ofthe Biosimilar Guidelines mandates that all three phases of human clinical trials must be carried out for a biosimilar drug. Therefore a biosimilar drug is required to be subject to the full rigour of all phases of clinical trials, as envisaged under the Drugs Act read with the Drugs Rules and the Biosimilar Guidelines.

75. It is submitted by the plaintiffs that in India, a biosimilar is usually approved with the corresponding INN of the innovator reference product. The practice of approving and marketing biosimilars under the INN of the innovator biological drug is not in accordance of the recommendations of the World Health Organisation regarding use of INNs by biosimilar manufacturers. Such recommendations acknowledge the necessity to distinguish a similar biologic from the innovator biological drug by use of unique biological qualifiers by the biosimilar manufacturers. It is an established biosimilar drug (approved as such after adequate testing under applicable law) may be entitled to use the INN assigned to the innovator biological drug. No biosimilar drug manufacturer is entitled to use the INN without conducting necessary tests and establishing biosimilarity under applicable law. In the absence of such tests, the defendant's drug cannot be approved as 'Trastuzumab' and cannot be marketed as such.