The division bench of the Delhi High Court, of Badar Durrez Ahmed and Sanjiv Sachdeva, has permitted Biocon and Mylan to use Roche’s product data for Trastuzumab. Roche had challenged the approval mechanism adopted by the central drug standards controller (CDSCO) in giving Biocon and Mylan approval for its biosimilar drug and their product inserts containing product data before the single judge.
Earlier, the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.
Roche has been successful in obtaining a temporary injunction from the Delhi High Court to block the expected launch of a biosimilar of breast cancer drug Herceptin (trastuzumab) by Reliance Life Sciences.
The order dated 2nd November 2015 of Justice Manmohan Singh of Delhi High Court restrains Reliance from launching the drug in the market till the next date of hearing.
Reliance Life Sciences has recently obtained approval for its biosimilar version of Herceptin named TrastuRel. According to Roche, Reliance Life Sciences has incorrectly been granted an approval by the Drug Controller General Office for TrastuRel. Roche argued that Reliance was supposed to conduct the clinical trials of all phases (I, II and III) to obtain an approval, however the approval has been granted without the clinical trials of Phase I and Phase II.
The Counsel’s for Roche argued that the result of clinical trial of Phase III is dependent upon the results of trials of Phase I and Phase II. Thus, on the basis of clinical trial of Phase III even if valid the product of Reliance Life Sciences cannot be treated as “biosimilar product of Roche”.
Justice Manmohan Singh held that serious issues are raised in the matter which would be decided after considering the explanation and reply of the defendants and till the next hearing Reliance has been restrained from launching the product.