Delhi HC strikes down breast cancer biosimilars' approval for Roche drug

The high court here has said government approval of breast cancer drug Canmab/Bmab 200 and Hertraz, biosimilars for Roche's patented drug and made in India by Biocon and Mylan, respectively, has not been in line with either international guidelines on similar biologics of of the Drugs and Cosmetics Act.

Roche was original marketer of innovator molecule Trastuzumab in India. Trastuzumab is a biological drug used primarily for the treatment of HER 2 positive breast cancer.  Biocon and Mylan, now selling the biosimilar version of this drug as Canmab/Bmab 200 and Hertraz, respectively, got the government approval in October 2013.

The court has permitted both Biocon and Mylan to manufacture and sell this drug but, as an interim measure, to not call their drugs “biosimilar” and/or “biosimilar to Herceptin, Herclon, Biceltis” or in any way ascribing any biosimilarity with Roche’s drugs.  In India, Trastuzumab is sold by Roche under the brand names Herceptin, Herclon and Biceltis.

It was Roche’s contention that the Canmab/Bmab 200 and Hertraz are being misrepresented as “Trastuzumab”, “biosimilar Trastuzumab” and a “biosimilar version of Herceptin”, without following due process (doing required tests, etc) in accordance with the Guidelines on Similar Biologics.  

“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,” Roche told this newspaper.

Roche told the court both the companies had conducted a very limited clinical trial and so, must not be permitted to use Roche’s data and information on Trastuzumab, which is publicly available.

“In view of prima facie findings, that the use of the data by Biocon and Mylan in the product insert without undergoing the entire process of the trials is misleading, the two companies are also restrained from using the data relating to manufacturing process, safety, efficacy and tests conducted for the safety of the drugs by Roche,” said the court.

This ruling will remain in effect till the time the final decision on the issue of biosimilarity is taken by the court. The court also told Biocon and Mylan to not use the name Trastuzumab as a standalone on the carton or package insert as a brand name.

Biological drugs are synthesized by cells or living organisms, as opposed to chemical drugs which are produced by chemical synthesis.