New Delhi: The Delhi High Court on Wednesday directed the Centre to inform the court whether it had granted an approval to Biocon Ltd’s package inserts for two indications of its biosimilar drug, Trastuzumab for treatment of early breast cancer and gastric cancer. Biocon had earlier made certain changes in accordance with the courts order for the package insert for breast cancer and had subsequently applied for approval for a fresh package insert for additional two indications of the drug—which was under dispute. “We have removed details with regards to certain clinical trials which were exclusive to Roche in the second package insert,” said Prathiba Singh, counsel for Biocon. Datar added that Roche was agreeable to Biocon agreeing to prefix its company name and sell the drug as Biocon’s trastuzumab. A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs.

Source: Mint February 22, 2017 17:33 UTC