Biocon, Mylan Likely to Appeal HC Ruling on Roche’s Cancer Drug
The court order imposed conditions on the drugmakers over selling copies of breast cancer drug trastuzumab
Vikas Dandekar 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
A Bitter Pill
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 that 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 non-proprietary name trastuzumab as Biocon’s Trastuzumab or Mylan’s Trastuzumab. The court came down heavily on Indi- a’s drug regulatory body for approving the products. As part of its 227-page decision, it said the “process followed is flawed and suffers from the vice of the non-application of mind and non-adherence of the statutory provisions of the Act and Rules as well as Biosimilar Guidelines…” Roche welcomed the order. The company said it is not against biosimilars, but maintained that it will continue to challenge those that fail to present the data outlined in the Indian biosimilar framework. “The ruling sends a strong, positive signal that the development, manufacture and approval of biosimilars in India must be subject to rigorous clinical and regulatory standards as per the applicable law,” it said.
Reliance Life Sciences, which has also been approved by the Indian regulator for introduction of its versions of trastuzumab and has been dragged to the court by Roche, said it has yet to receive a copy of the order. The company said it received inputs from its lawyers on the operative part of the judgment. “There is no impediment on launching of the product. Reliance Life Sciences is working on an appropriate date for the commercial launch of the product, within the framework of the judgment and based on legal advice,” it said.