Biocon, Mylan allowed to sell 3 cancer biosimilars

The legal battle involving drugmaker Roche’s breast cancer drug Trastuzumab took a significant turn on Friday with the Delhi High Court allowing drugmakers Biocon and Mylan to sell their version of the biosimilar drug for three treatment indications.

Biocon and Mylan will now be able to sell their version of the drug to treat metastatic breast cancer, gastric cancer and early breast cancer, until further orders from the Court. Counsel for Biocon and Reliance Life Sciences, Pratibha Singh said that the interim order reiterates that India does not recognise data exclusivity and that data of the innovator company can be relied upon by the drug regulator, while approving a biosomilar drug.

Today's development is significant in the biosimilar drugs regulatory landscape, as biological drugs are seen as the next frontier in treatment.

Biosimilars are “highly similar” versions of an approved biological drug.

They are complex, sensitive and difficult to make. And like generic drugs in allopathy, biosimilars are also priced less than the innovator drug.

Expressing its disappointment, Roche said that today’s decision denied patients and doctors the right to make an informed decision. “Today’s decision 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. We believe it is important to ensure physicians and patients are not misled into believing these medicines will provide the same benefit and safety experience as our innovator medicine Herceptin,” Roche said.

Pointing out that they were evaluating their options, the multinational said, “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.”

Welcoming the interim order, Biocon's spokesperson said, “The Division Bench not only has stayed the operation of the order of April 2016, but also pronounced in court that Biocon can use the Package Insert for all three indications including the publicly available data of the reference product therein as it has been approved by the Drugs Controller General of India (DCGI).“ This will pave the way for greater access to affordable biosimilar trastuzumab for cancer patients in India, the spokesperson added.

But the Campaign for Affordable Tratuzumab said that while the decision lifted some of the uncertainty surrounding the sale of the drug here, the battle to make this drug affordable was not over.

“The cost of each 440 mg vial has fallen from over ₹1 lakh to under ₹30,000 for each 440 vial due to competition which is still to high in relation to the actual cost of production. And hospitals treating women with HER2+ breast cancer are charging profit margins of 25-40 per cent on each vial administered .Many of them cannot bear the financial burden of procuring the drug for 17 cycles after paying for surgery and chemotherapy,” said Leena Menghaney, a spokesperson for the campaign.

She called for Government action similar to that seen recently on cardiac stents, where the Government cracked down on distribution margins that were inflating the cost of the stent for patients.

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