New Delhi: The Delhi high court on Friday gave a green signal to pharmaceutical companies Biocon and Mylan to manufacture and sell its biosimilar drug Trastuzumab for early breast cancer and metastatic gastric cancer.
The court had earlier allowed them to sell its biosimilar drug for metastatic breast cancer.
As a result, Biocon and Mylan, which were facing a challenge from Roche for sale of the biosimilar drug for three indications—metastatic breast cancer, early breast cancer and gastric cancer—would now be free to sell these drugs.
“Till further orders, Biocon and Mylan are permitted to manufacture and sell Trastuzumab under their brand names for all the three indications on the basis of the product inserts which have been approved by the competent authority," said a bench headed by Justice Badar Durrez Ahmed.
The court, through an interim order, quashed Roche’s challenge to the sale of drugs by Biocon and Mylan as the requisite approvals for both biosimilarity and product inserts had been granted by the Drug Controller General of India (DCGI).
Roche had opposed certain paragraphs in the product inserts for the additional indications, and claimed that Biocon and Mylan were passing off clinical tests conducted by them as theirs.
“Biocon and Mylan have not conducted any tests for biosimilarity of the addition indications for metastatic gastric cancer and breast cancer. The limited information to the extent where Biocon and Mylan have used our information regarding the tests for drugs ought not to be used." Rajiv Nayyar, counsel for Roche, told the court.
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.
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.
“We are disappointed by today’s decision because it denies patients and physicians the right to make informed decisions about the treatment of breast cancer. It means critical information about the clinical studies of our product Herceptin, will be included on the packaging for these products even though there continues to be no evidence in the public domain that the companies producing these products have conducted the studies required for biosimilars." Roche said in a statement after the court’s order.
“As the holder of the Herceptin trademark and the innovator of Trastuzumab, Roche has a duty to its patients to ensure that a company that claims its products are comparable to ours have really followed and been assessed in relation to the rigorous clinical and regulatory standards outlined in the Indian Biosimilar Framework. The safety of patients will always remain a priority for Roche and we will continue to challenge companies that fail to present the data outlined in the Indian biosimilar framework," it added.
The court in its prima-facie view had 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 was 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, had said that Biocon could 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.