New Delhi: An appeal against an approval granted by the Drug Controller General of India (DCGI) in case of a biosimilar drug would lie before the Central government, the Centre told the Delhi high court on Monday.
The court was hearing the issue of maintainability of a case brought by Swiss drug maker Roche over an approval of a biosimilar version of a breast cancer drug being marketed by Ahmedabad based pharmaceutical company, Cadilla Healthcare under the name Vivitra.
“Any decision which the Centre takes for granting permission has to be construed as an order and an appeal against it may be heard by the Centre itself," Sanjay Jain, additional solicitor general appearing for the Centre told Justice Rajiv Sahai Endlaw who was hearing the aspect of maintainability of the matter.
Roche had objected to an approval granted by the Centre to Cadila on the basis of which they had launched a biosimilar version of the formers’ drug, Trastuzumab which was being sold under the name Vivitra. The Swiss giant had claimed that Cadilla’s drug had been launched without conducting adequate clinical trials and in ignorance of the provisions under Drugs and Cosmetics Act, 1940.
“Cadilla is wrongfully using my propreitary information and misrepresenting my test results to be theirs...They are seeking to substitute my results of phase II trails as their own," said Sandeep Sethi, counsel for RocheB.
On a similar issue, Roche had dragged Biocon Ltd and its partner Mylan Pharmaceuticals Pvt. Ltd to court which on 28 May allowed them to continue marketing their breast cancer drug by making changes in their package insert and without ascribing biosimilarity to Roche’s trastuzumab.
A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs.
Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
Roche’s subsidiary Genentech Inc. is the innovator of monoclonal antibody trastuzumab, which is used primarily in the treatment of HER 2 positive breast cancer.
Roche and its licensed partners market trastuzumab in India under brand names such as Herceptin, Herclon and Biceltis.
The court will hear the matter next on 26 September.