Have you approved Biocon’s package inserts for Trastuzumab, Court asks Centre

The Delhi High court was hearing an appeal by Biocon and its partner Mylan which had challenged a single judge interim order restricting them from marketing Trastuzumab


The Biocon case will be next heard on 2 March. Photo: Hemant Mishra/Mint
The Biocon case will be next heard on 2 March. Photo: Hemant Mishra/Mint

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.

A bench comprising of justices Badar Ahmed Durrez and Sanjeev Sachdeva observed that the case would proceed on whether the approval for the new package insert by the Drug Controller General of India (DCGI) had been given or not.

The court was hearing an appeal by Biocon and its partner Mylan Pharmaceuticals Pvt. Ltd which had challenged a single judge interim order restricting them from marketing the drug, an innovation of Roche Holding AG’s unit Genentech Inc.

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Roche submitted that Biocon had failed to follow protocol and not conducted tests and was selling its drug under the name Trastuzumab—of which they claimed to be the innovator.

“Unless Biocon follows the steps, they are not entitled to sell it under the name, trastuzumab under common right law. All the tests have been conducted by me and they are passing if off as theirs.” said Arvind Datar, counsel for Roche.

Datar added that Roche was agreeable to Biocon agreeing to prefix its company name and sell the drug as Biocon’s trastuzumab. He added that Reliance Life Sciences, who had been dragged to court on the same issue was doing so.

The court in its prima facie view held that Roche did not have any right to claim ownership over Trastuzumab and its use by Biocon would not amount to dilution or passing off. It also observed that in such a case a challenge could be brought before the licensing authority (Centre) and that this may not be the appropriate forum.

In its interim order on 25 April, the court allowed sale and manufacture of Trastuzumab by Biocon and Mylan with certain restrictions on packaging and on use of Roche’s data in the product insert for the drug.

Justice Manmohan Singh, in a 227-page interim order, said that Biocon can continue to sell and manufacture the drug, without calling their product a “biosimilar” and/or “biosimilar to Herceptin, Herclon and Biceltis”, or in any way ascribing any bio-similarity with that of the Roche products in any form of communication.

A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs.

Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

The case will be next heard on 2 March.

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