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).
In 2002, Roche launched trastuzumab under the brand name Herceptin in India marketing each 440 mg vial at INR 120,000. The Campaign for Affordable Trastuzumab, launched in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women’s rights activists and eminent jurists – demanded that the Government of India intervene to enable the production of biosimilars and ensure that the drug is made available to all those who can benefit from it.
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 at Rs.75,000/- per 440 mg vial which was still out of reach of most patients.
In 2013, after facing challenges to its evergreening patent claims and its granted patent listed as a candidate for a compulsory license by a inter ministerial expert committee formed by the Health Ministry, Roche chose to withdraw its patent in India in August 2013.
For more information, read here
After having obtained the requisite approvals in late 2013 from the Indian Regulatory Authority, Indian manufacturer Biocon and its partner – Mylan started to market biosimilar Trastuzumab under the brand names CANMAb and Hertraz in Feb 2014.. Immediately, Roche launched a court case against the Indian regulatory authority challenging approval of drugs given to the companies in an effort to prevent the marketing of potentially affordable versions of trastuzumab, and also argued that that it had data exclusivity and copyright on the clinical studies published in its package insert accompanying the pharmaceutical product. Roche has also filed similar suits against later generic entrants – Reliance Lifesciences and Cadila Healthcare Ltd.
More recently, the Delhi High Court’s Division bench in March 2017 upheld the Indian drug regulator’s approval given to Biocon and Mylanto market the cancer drug during the pendency of the civil suit for all indications.
Trastuzumab is now included in by National List of Essential Medicines and a number of public sector entities such as CGHS, Indian Railways either re-imburse or procure the drug. 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 after competition has dropped to Rs, 29,500 – 33,000 per 440 mg vial and distributors are offering one vial free after a patient purchases 3 vials.