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8. The Appellant‟s biosimilar drug, on the other hand, is called „TrastuRel‟, which is stated to be biosimilar version of the respondent nos. 1-3 (Roche) „Trastuzumab‟. The appellant obtained approval for research, examination and analysis in relation to the said Biosimilar drug Trastuzumab in 2009. Subsequently on 18.11.2010, the Review Committee for Genetic Manipulation (RCGM) had granted the appellant the license to conduct pre-clinical toxicological studies and directed the appellant to approach respondent no. 4 (DCGI) for conduct of clinical trials on 28.07.2011. Thereafter, on 29th October, 2012, respondent no. 4 after being satisfied with the data so submitted, granted permission to the appellant herein to conduct Phase-III clinical trials. Finally, based on the data so generated from the trials, the permission to manufacture the bio similar drug was granted to the appellant on 2nd June, 2015. The grant of approval for manufacture was followed by the discussions and considerations of the data by the expert committees such as NDAC (New Drug Approval Committee)/ SEC(Subject Expert Committee),Technical Committee and Apex Committee.

12. The case of the respondents (plaintiffs/ Roche) was that the appellant‟s drug „TrastuRel‟ could not establish biosimilarity at each stage of product development and testing, specifically in product characterization, pre-clinical (i.e., animal) trials and clinical (i.e., human) trials, due to non testing of the same as mandated under the D&C Rules and the Biosimilar Guidelines. It was further contended that the defendant no. 3 (appellant herein) also failed to fulfill the safety criteria mandated under the aforesaid rules and guidelines, as adequate data to establish safety, efficacy and immunogenicity had not been generated. Thus, appellant‟s could not claim their drug to be biosimilar for any of the indications.

39. Mr. Lall further submits that the appellant, like the other two manufacturers of biosimilar Trastuzumab viz. Biocon Limited and Mylan, Inc., had extrapolated data from the tests conducted by respondent (Roche), for the 1st indication (Metastatic breast Cancer), for obtaining approvals as specified under the Biosimilar Guidelines, 2012. He submits that the appellant‟s drug „TrastuRel‟ has been in the market for the last three years as on date, while the other two appellants/ defendants Biocon and Mylan have had their product for the last five years. Thus, the appellant should not be deprived of similar relief. The only reason that the Division Bench did not pass a similar order in the appeal of the appellant - as passed by the Division Bench in the appeals of Biocon and Mylan, was that the appellant had not launched its biosimilar drug by the time the interim stay applications in those other connected appeals by Biocon Limited and Mylan Inc., were heard and decided.

44. Mr. Wadhwa submits that under paragraph 7.2 and 7.3 of the Biosimilar Guidelines, a mandatory comparative pre clinical trial is to be conducted, which comprises of: (a) animal toxicology, (b) animal pharmacology and (c) study of immune responses in animals. Further this is also mandated under Rule 122 B and also under paragraph 1(1) (ii) and (iii) of Schedule Y of the D&C Rules. Learned senior counsel submits that only animal toxicology studies were conducted for the indication of Metastatic Breast Cancer, while animal pharmacology studies were not conducted as per Rules by the appellant. Further, the animals on which the appellant had conducted the preclinical studies, were of a different species as compared to the respondents „Trastuzumab‟, thus, in contravention of the biosimilar guidelines as animal trials for a purported biosimilar must be conducted on the same species as conducted by the innovator drug.