OPPI seeks new product status for biosimilars in India

Monday, May 12, 2008 08:00 IST
Gireesh Babu, Mumbai

The Organisation of Pharmaceutical Producers of India (OPPI) has sought the Union Health Ministry to consider classifying all biosimilar products as new products enforcing all the procedures needed for the approval of a new product in the market.

The OPPI in its recent representation to the Union Health Ministry pointed out that the biosimilars vary from the innovators due to their nature and complexity of manufacturing process, though the sameness of molecular structure in chemistry based generic medicines is very much defined. Any alteration to the manufacturing process of biological drugs may result in a completely different product and it should not be considered as a similar product to the original biopharmaceutical product from the innovator company.

Further, the biogeneric product cannot be defined with the same criteria of chemistry based drugs, as the post-translational modifications are dependent on the host cell and process. "Moreover, as bioequivalence approach is not scientifically appropriate for biogenerics, all applications in India should be submitted in the Appendix 1 format rather than the 1A format requiring complete data submission like a new drug," averred Tapan Ray, director general, OPPI.

"We have submitted our views on the issue to the Drugs Controller General of India, who has given us a clear positive sign on the proposal, very recently. This step will ensure better patient safety on biosimilar products," he said. He also added that the organisation has made a proposal to establish a system for proper enforcement of patent in India. The Patent Enforcement System must ensure that during patent life of a product in India no marketing approval is granted to a generic equivalent of the same product. The OPPI's suggestion came in the wake of a recent patent row between Hoffman La Roche and Cipla Ltd over the marketing of the former's anticancer drug Tarceva and its generic version, Erlocip.

The OPPI has also demanded the Government to set time limit for filing pre-grant patent oppositions in India. The organisation suggested that the patent office should fix a time limit of six months from the date of publication of patent as the duration to file pre-grant opposition. OPPI also suggested that pre-grant opposition must be disposed off within 12 months from commencement of pre-grant proceedings and if not concluded within 12 months, equivalent patent term restoration to be provided. Currently, there is no time limit set for this and it has made the global innovator companies feel uncertain about product launches in India.

The organization has also offered its support for capacity building exercise in Indian Patent Office, as the authority has over one lakh patent applications pending for consideration. "From 2005 to 2008, about 10 pharmaceutical products have been granted patent by the Indian Patent Office. As we understand, there are only around 40 patent examiners in the patent office and the work is moving at a snail's pace. We have expressed our willingness to collaborate with the Department of Industrial Policy and Promotion towards capacity building and sharing best practices with the patent office,"