CCI rules in favour of Biocon in case against Roche over breast cancer drug

Biocon and Mylan started marketing biosimilars of Roche's Trastuzumab drug in 2014

The Competition Commission of India (CCI) has given directions for carrying out a detailed investigation to ascertain if Roche used its dominant position to maintain its monopoly over the breast cancer drug Trastuzumab.  

The order comes as a response to a joint complaint filed by the Mylan and Biocon in 2016 alleging that the Roche Group indulged in "abusive conduct".

"The Commission is of the considered view that, prima facie, the contravention with regard to Section 4(2)(c) of the Act is made out against Roche Group, which warrants a detailed investigation into the matter. The DG is, thus, directed to carry out a detailed investigation into the matter", said the order.

Both Mylan and Biocon further alleged that the group tried to influence regulatory authorities to deny the sale of biosimilars of Trastuzumab by them. Roche had allegedly informed the regulators that biosimilars of Mylan and Biocon were hazardous to patients.

The group was further accused of affecting the entry of market players who sought the approval of requisite authorities for the launch of such biosimilars in the Indian market.

In 2002, Roche launched Trastuzumab under the brand name Herceptin in India marketing each 440 mg vial at Rs 1,20,000.

A campaign for Affordable Trastuzumab was launched in November 2012 and it demanded that the Government of India intervene to enable the production of biosimilars and ensure that the drug is made available to all.

Roche, subsequently, withdrew its Herceptin and launched the drug under the brand name Herclon and Biceltis (marketed by Emcure who distributed it) at a slightly lower price of Rs 75,000 for a 440 mg vial, which was still out of reach for most patients.

In 2013, after facing challenges to its patent claims, Roche chose to withdraw its patent in India in August 2013.

After obtaining requisite approvals from the regulators in 2013, Biocon and Mylan started marketing biosimilars of Trastuzumab under the brand names CANMAb and Hertraz in 2014. Roche filed a case against the regulators for issuing licenses to these companies for the said drug.

More recently, the Delhi High Court's Division bench in March upheld the Indian drug regulator's approval given to Biocon and Mylan to market their cancer drug during the pendency of the civil suit for all indications.

Trastuzumab is now included in the National List of Essential Medicines and a number of public sector entities such as the CGHS, Indian Railways either reimburse or procure the drug.

A majority of patients in India have to pay for Trastuzumab themselves and some have been seeking financial assistance from the PM's National Relief Fund to access the drug.

The price of Trastuzumab has dropped to range between Rs, 29,500 and Rs 33,000 per 440 mg vial and distributors are offering one vial free after a patient purchases three vials.