In a major turn of events, the Indian arm of Swiss pharma major Roche, recently sued Bangalore based Biocon and US based generic giant Mylan in Delhi High Court (HC) for launching world's first biosimilar version of its original breast cancer drug Herceptin (trastuzumab) in India. It is understood that the company has also sued the Drug Controller General of India (DCGI) for giving permission for such a launch.

Roche has told the court that the drugs of Biocon and Mylan are being misrepresented as 'biosimilar Trastuzumab' and 'biosimilar version of Herceptin' without following the 'due process in accordance with the guidelines on similar biologics' for getting approvals in India. The Swiss company also argued that there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

Roche further contests that guidelines on similar biologics were only issued in 2012, which laid down 'a detailed and structured process for comparison of biosimilar with the original product and "all the applications for manufacturing and marketing authorization" of biosimilars have to follow that path before getting an approval. Roche also claims that DCGI has approved Biocon's "protocol and design study for testing" related to the proposed drug even before its own regulatory guidelines were firmed up.

The affordable and convenient biosimilar trastuzumab developed jointly by Biocon and Mylan is the world’s first biosimilar version of Herceptin. CANMAb is manufactured at the biologics facility at the Biocon Park and was supposed to be available to patients in the next few weeks in February. However, following the legal move, the Delhi High Court has restrained Mylan and Biocon from relying upon or referring to Herceptin or any data relating to it for selling or promoting their brands Canmab (Biocon)and Hertaz (Mylan) till the next hearing.

It is understood that Trastumab was being considered for a compulsory license, but Roche pre-empted the move by not renewing the patent here. Interestingly, only last month Biocon had entered into the breast cancer therapy space with the manufacture of an affordable novel biosimilar trastuzumab under the brand name ‘CANMAb’ to treat HER2-positive metastatic breast cancer in India. It recognizes the company as one of the leading Indian oncology companies since it offered BioMAb EGFR for head and neck cancer in 2006 in the county which benefited over 5,500 patients till date.

The targeted therapy for HER2-positive breast cancer acts by interfering with HER2 protein production to impede cancer cells growth. It is easy to administer and given intravenously, once every three weeks or on a weekly basis depending on the patient’s condition. Unlike the product currently available in the market, both 150 and 440 mg formulations of CANMAb can be stored for one month which is an important offering for Indian patients as it ensures there is no under dosing or wastage of drug that is quite common today.

CANMAb is supposed to be available at about 25 per cent discount to the current list price of the reference product in India, which is already significantly lower than its price in developed markets. While its 150 mg is priced at Rs.19,500 per vial, the 440 mg costs Rs.57,500. The 150 mg dosage allows extra savings to patients as they can buy smaller quantities as per their requirement.