Rules Roche’s practices prima facie appear to be aimed at blocking affordable biosimilar trastuzumab – a cancer drug – in India
In July 2016, Mylan Pharmaceuticals and Biocon Limited approached the Competition Commission of India regarding Roche’s anti-competitive conduct to protect and maintain its monopoly on the biologic drug Trastuzumab used in the treatment of HER2-positive breast cancer. According to the complaint, the Swiss pharmaceutical corporationhas been denying market access to its competitors through array of activities like influencing regulatory standards, raising unwarranted concerns regarding the safety and efficacy of biosimilars, influencing tender conditions and abusing the legal process to stall approval and marketing of the biosimilar. Roche misused its dominant position to try and block more affordable biosimilars developed in India.
The Competition Commission in a path breaking decision (Case No. 68 of 2016 – Roche – Mylan Biocon CCI Order 68 of 2016) has ruled that the complaint has merit relating to abuse of dominant position by Roche has merit and that the pending Civil Suit in the Hon’ble Delhi High Court does not impede the Commission’s jurisdiction to look into the present matter (para 41).
Highlights of the order
Thus, the practices adopted by Roche Group to create an impression about the propriety of the approvals granted, the safety and efficacy of biosimilars, the risk associated and the outcome of the on-going court proceedings in the medical fraternity, including doctors, hospitals, tender authorities, institutes etc., when seen collectively, prima facie appear to be aimed at adversely affecting the penetration of biosimilars in the market (para 74).
The Commission is of the considered opinion that biological drugs as well as its biosimilars form part of the same relevant product market. In the present case, the relevant product market, thus, would be the “market for biological drugs based on Trastuzumab, including its biosimilars” (para 49)
Even a partial denial of market access that takes away the freedom of a substitute to compete effectively and on merits in the relevant market, may amount to a contravention of Section 4(2)(c) of the Act (Para 77).
Based on the foregoing analysis, 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 detailed investigation into the matter. The DG is, thus, directed to carry out a detailed investigation into the matter, in terms of Section 26(1) of the Act, and submit a report to the Commission, within 60 days (para 81).