Delhi High Court order on copies of Roche's cancer drug draws flak

MUMBAI: Makers of biosimilar drugs are unhappy with a Delhi High Court ruling that imposed certain conditions on Biocon and Mylan to sell copies of Roche’s blockbuster biotech-based breast cancer drug, trastuzumab.

The April 25 order, which raised questions on the processes followed by the Indian drug controller in approving such drugs, could also affect the availability and affordability of an expensive cancer treatment, said an industry executive. Based on Roche’s plea, the Delhi High Court in a keenly watched legal tussle said the approvals to Biocon’s brand CANMAb and Mylan’s Hertraz were “not on the basis of the adherence of the guidelines” and “rules framed under the Drug Act.” Roche sells the drug under the brand Herceptin globally. In India, it is sold as Herclon and Biceltis.

While sources said Biocon is preparing for an appeal, the company did not comment on specific questions except saying it will deal with the issue appropriately. Mylan confirmed its plans to file an appeal to challenge certain limitations imposed on the packaging and labelling of its product.

The two companies had strongly contended that due processes had been followed in securing the approvals for their products.

DG Shah, secretary general, Indian Pharmaceutical Alliance strongly opposed the court action and said the court has ruled on a matter that drug regulatory experts are struggling with across the world. “The ruling would mean that a biotech product made by one company in two different plants is not the same … The drug approval will have to be specific to the manufacturing location.

Likewise, a product made in the lab for approval and then scaled up for commercial production is also not the same,” he said.

The order had restrained the biosimilar makers from using data relating to the manufacturing process, safety, efficacy and tests till the time a final decision is made on the issue of biosimilarity. Siding with Roche’s plea, the court noted the products cannot be called a “biosimilar” of Herceptin, Herclon or Biceltis, or in any way ascribe any biosimilarity with that of the innovator’s products.

The order also required the biosimilar companies to use international nonproprietary name trastuzumab as Biocon’s Trastuzumab or Mylan’s Trastuzumab.