NGOs want biosimilar norms changed to lower drug prices

The cost of the new class of anti-cancer medicines fall in the range of Rs 2 lakh to nearly Rs 4 lakh for one dose or vial.

With prices of several new anti-cancer drugs in the range of tens of lakhs, nine non-governmental organisations have written to the Union government to revise the existing guidelines on biosimilars for better availability of such medicines in the Indian market at an affordable price.

The existing rules require the manufacturers of biosimilars—off-patent drugs that are nearly identical to the original medicine—to carry out animal testing and clinical trials, leading to an increase in cost and the time taken for these medicines to enter India.

Against this backdrop, nine NGOs that work on public health and patient rights wrote to the Union Health Secretary Rajesh Bhushan and Department of Biotechnology Secretary Rajesh Gokhale earlier this week to revise the Biosimilar Guidelines of 2016 and facilitate access to quality biosimilars at an affordable price.”

The cost of the new class of anti-cancer medicines like pertuzumab, pembrolizumab or obinutuzumab fall in the range of Rs 2 lakh to nearly Rs 4 lakh for one dose or vial.

“An 18 month long treatment with pembrolizumab (used for melanoma, lungs and head and neck cancer) will cost around Rs 72 lakhs. A two-year treatment with pertuzumab (breast cancer) will cost around Rs 48 lakh,” said Chetali Rao from Third World Network.

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With cancer treatment often taking months, such pricing is bound keep these medicines out of reach for most common Indians. The same is true for gene therapy, which is available for certain types of neuromuscular disorders.

The activists argued that with rapid advancement of analytical technologies, there are tools available with drug regulators to ensure the quality of biosimilars without compromising on quality. This will substantially reduce the cost of the treatment using such medicines.

“Without such entry barriers, more companies can come forward to make biosimilars, resulting in a drop in the medicine prices,” K M Gopakumar, from Working Group on Access to Medicines and Treatments and one of the signatories to the letter, told DH.

The NGOs cited not only the 2022 WHO biosimilar guidelines that did away with animal tests and simplified trial norms, but also quoted the latest rules from the UK, USA, and Canada that waived off the need to conduct animal studies and simplified procedures to carry out efficacy trials for the approval of biosimilars.

The rights groups observed that waving off comparative efficacy studies and in-vivo animal toxicity studies, would drive down the cost of production of biosimilars and significant savings from streamlined biosimilar development could be achieved while maintaining the safety and efficacy of the biosimilar product. This will facilitate affordability and access of bio-therapeutic products to patients in need of such treatments.

Top sources within the government told DH that an expert committee had been reviewing the existing biosimilar guidelines and a new set of guidelines might come up soon.