HONG KONG – The High Court of Delhi has forbidden Biocon Ltd. and Mylan Inc. from comparing Canmab and Hertraz to Roche AG’s breast cancer drug Herceptin (trastuzumab), even though they were approved as biosimilar versions of the drug.

The injunction, sought by Roche, doesn’t prevent them from promoting Canmab and Hertraz but without the comparison to the original drug – and if the injunction is allowed to stand – it could make a mockery of India’s biosimilar pathway.

On Jan. 18, Biocon launched Canmab, which was co-developed with its U.S.-based partner Mylan Inc. (NASDAQ:MYL) as Canmab in India. Mylan is using the brand name Hertraz.

The Herceptin patent will expire this year in Europe and in 2019 in the U.S. Global sales for Herceptin were $6.4 billion in 2012, but just $21 million in India.

Roche claims there is a lack of proof of Canmab’s equivalence to the innovator trastuzumab in efficacy and safety. Biocon has been banned from referring to any data linked to Herceptin in its promotional material at least until the next hearing on Feb. 28.

“Roche has filed and secured an injunction against Biocon and Mylan. The injunction prevents the companies from comparing their products to Herceptin,” Roche spokeswoman Silvia Dobry told Reuters. (BioWorld’s parent company is Thomson Reuters.) She said Roche had taken this action to make sure Biocon and Mylan’s products really had demonstrated comparable efficacy and safety to Roche’s drug. “It is unclear if the products meet the criteria for biosimilar products.”

“It is an extremely shocking, but not unexpected development especially as Roche had decided not to pursue Indian patents for their breast cancer drug,” Biocon said in a statement. “This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab. Canmab and Hertraz co-developed by Biocon and Mylan are world-class products that adhere to stringent quality standards and have been developed on the basis of applicable biosimilar guidelines.”

Biocon said the court will not support the injunction.

Breast and cervical cancer are the most prevalent cancers for women in India. Biocon said there are about 150,000 new patients diagnosed with breast cancer every year.

Canmab can be used to treat as many as a quarter of cases that are HER2-positive.

Most of the patients in India cannot afford the innovator drug, which has in turn limited the extent of HER2 testing across the country, so there many be even more cases than are reported.

“Biocon intends to make a significant difference in the treatment paradigm for HER2-positive breast cancer in India by enhancing access to more affordable treatment with Canmab (biosimilar trastuzumab), which offers the same level of safety and efficacy as the reference product,” said Mazumdar-Shaw in the company’s announcement. “The launch of Canmab in India is an important milestone for our biosimilars program and demonstrates our ability to deliver on our promise of affordable innovation with a high quality, world-class product.”

Trastuzumab interferes with HER2 protein production and stops the growth of cancer cells. It is given to the patients every three weeks or on a weekly basis depending on the condition. The drug has a relatively long storage period of one month, which limits under-dosing or waste.

Manufactured at Biocon’s biologics facility in Bangalore, Canmab was originally intended to hit the market during the first week of February. The company priced Canmab at INR19,500 (US$313) per vial of 150 mg and INR57,500 (US$925) for 440 mg.

“The drug will be available at about 25 percent discount to the current list price of the reference product in India, which is already significantly lower than its price in developed markets,” said Biocon in announcing the launch.

Biocon hopes that the introduction of this cheaper alternative for breast cancer patients in India will enlarge its patient pool.

Biocon’s third quarter report acknowledged that the launch of Canmab was the most important event of the quarter.

“Q3 FY14 has been a very eventful quarter for us, with several research milestones across our novel molecules and biosimilars portfolio. The key highlight was the DCGI approval for our biosimilar Trastuzumab, which paved the way for its commercial launch in India as Canmab,” said Kiran Mazumdar-Shaw.

Biocon’s revenue from biopharmaceuticals grew 14 percent year-over- year in Q3 FY2014, which means biopharmaceuticals earned the company INR5.17 billion (US$83 million).

Biocon’s biosimilar insulin portfolio is growing. In partnership with Mylan again, Biocon is working to initiate a Phase III global clinical trial for its generic insulin, Glargine.