India’s Supreme Court has refused to ban domestic company Zydus Lifesciences from manufacturing and selling a biosimilar of the anticancer drug nivolumab, developed by American pharmaceutical company Bristol Myers Squibb (BMS), reports The Economic Times.
The judicial authority ordered BMS to conduct a comparison of the Zydus Lifesciences product against its patent and only thereafter seek interim legal protection based on the results of this examination. Since a biosimilar is not an exact copy but rather a biological product “similar” to the original, proving their complete identity at the molecular level is rather challenging. This provides grounds for the Indian company to assert that its formula differs and that the BMS patent does not apply to it.
Bristol Myers Squibb approached the Supreme Court in an attempt to overturn the Delhi High Court ruling, which on January 12 authorized Zydus to commence production of its nivolumab biosimilar. During the proceedings, Zydus stated that its treatment would be approximately 70% cheaper than the patented version. “If the product in question is life-saving, the decision must be made in favor of public interest. Withholding such therapy could cause immense and irreparable harm to hundreds of thousands of lives,” the Delhi High Court noted in its ruling.
Furthermore, the court stated that the BMS patent expires in just a few months, on May 2, and therefore this decision “will protect the interests of both parties and ensure the product’s availability to the public.”
