The petition states the approval of Cadila’s drug as a biosimilar has caused Roche “irreparable damage” in violation of applicable law for testing and approval of biosimilar drugs.NEW DELHI: Swiss biotech giant Roche has sued Ahmedabad-based Zydus Cadila and India's central drug regulator at the Delhi High Court over the approval and launch of breast cancer drug Vivitra (trastuzumab). Roche is planning to block the product from the market.
Roche, according to the petition, has taken objection over the approval and launch of a purported biosimilar version of its own trastuzumab without adequate tests in line with the provisions of the country's Drugs and Cosmetics Act as well as the biosimilar guidelines. Biosimilars are copies of complex biotech drugs.
The petition states the approval of Cadila's drug as a biosimilar has caused Roche "irreparable damage" in violation of applicable law for testing and approval of biosimilar drugs.
Roche declined to comment on the subject while Cadila did not respond to ET's queries.
Cadila launched Vivitra in January this year, joining Biocon and Mylan, which had launched their own copies of trastuzumab in 2014.
Cadila had already filed a petition in the Bombay High Court in anticipation of an injunction from Roche after the Swiss company took Biocon, Mylan and Reliance Lifesciences to court.
Roche and its Indian partner, Emcure, market trastuzumab as Herclon or Biceltis in India.
In an earlier decision, the Delhi High Court had directed Biocon and Mylan to make label changes and market their drugs without ascribing biosimilarity to Roche's trastuzmab brands.
Published by: News
Source: ETHealthworld
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