Introduction The World Trade Organization (WTO), via the TRIPS agreement, has set out various governing…
Trastuzumab/Herceptin has been amidst several controversies off lately and this time it is regarding a biosimilar which has jointly been manufactured by Biocon and Mylan.
Roche’s breast cancer drug Herceptin sold under the brand names HERCEPTIN, HERCLONTM and BICELTIS is a biological drug used primarily for the treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer on a worldwide basis and enjoys a global reputation.
Since its the most prevalent cancer among Indian women, with approximately 150,000 new patients getting diagnosed every year in India, the originator drug costing around US$3,000–US$4,500 (INR 1.64–2.45 lakh) for a month’s treatment, making it unaffordable to many of Indian citizens leading to lack of affordable treatment options for HER2+ patients which also lead to a campaign in March 2013 to urge the Govt to take appropriate measures to ensure affordability of Herceptin.
However, after several months of deliberation and debates, the Department of Industrial Policy and Promotion (DIPP) refused a plea for compulsory licensing for Trastuzumab.
Also, last year in a very surprising development Roche decided not to pursue Herceptin patents in India.
Keeping in mind all these factors, the approval by the Drugs Controller General of India (DCGI) and launch of Biocon’s CANMAb December last year the world’s first biosimilar versions of Roche’s blockbuster cancer drug ‘Herceptin’, is highly likely to be an alternative affordable option, being marketed at about 25% discount to the current list price of the reference product in India.
But in spite of all the pricing advantage, ex parte proceedings by Roche at the Delhi High Court last week has led to an injunction stopping two pharmaceutical companies i.e.; Biocon’s Canmab and its partner Mylan’s Hertraz from being launching, introducing, selling, marketing and/or distributing its branded drug Herceptin on the grounds of not being able to satisfy the requirements for a biosimilar drug in accordance with the guidelines. Also, the other issue raised was that of passing off; where Roche contended that the defendants were seeking to pass off their products as being equivalent in quality and class to Herceptin by referring to their products as “biosimilar version of Trastuzumab/Herceptin.
Requirements for Biosimilars in accordance with guidelines
“Biosimilars” are biological products that are similar to the innovator biopharmaceutical product.
In view of the structural and manufacturing complexities involved in the production of biopharmaceuticals, a biosimilar product can only be similar to the innovator biopharmaceutical product; it cannot be a generic equivalent of the innovator biopharmaceutical product.
Also, with the development and growth of the market for biosimilars in India and the international standards for approval of such products, the Guidelines on Similar Biologics were issued in 2012 which lay down specific standards for the development and evaluation of similar biosimilar biologics.
After the issuance of the Guidelines on Similar Biologics, all the applications for manufacturing and marketing authorization of similar biologics in India are required to be evaluated on the basis of the standards set forth on it ie;
the demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic.
However, Roche 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 and 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.
Also, Roche has cast doubts in its submission saying the Indian drug regulator’s approval for biosimilars couldn’t have come about in ‘such a short period’ when its ‘prescribed procedure’ in the guideline is so long.
The Swiss company argues 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.
In my opinion, no matter whether it’s a biosimilar of Herceptin or not, clinical trials should be rigorously practiced according to the new guidelines issued by the Indian Govt.
With respect to human safety, there is a very big question which highlights the negligence of the drug controller who gave approval to Biocon and its partner Mylan without the necessary clinical trials being conducted.
About the Author: Sugandhika Mehta, Patent Intern at Khurana and Khurana and can be reached at [email protected]