Earlier this month, a letter from civil society groups urged the Centre to revise India’s biosimilar guidelines to facilitate access to quality drugs at an affordable price.

Within hours of it becoming public, the letter saw a push back of sorts. Voices emerged in disagreement saying any such attempt at rationalisation could put patients at risk, as it would allow sub-par biosimilar products to get launched.

Industry watchers observe that the earlier battle between innovators and those making generic (similar) versions of the medicine seems to have now shifted to the bio-pharmaceutical landscape. And at its cross-hair sits biosimilar products, or a product that is “highly similar” to the original biological product.

Barriers to approval

Biologics, the US Food and Drug Administration explains, are those isolated from a variety of natural sources — human, animal, or microorganism — and produced by biotechnology and other methods. They are the fastest-growing class of medication in the US and account for a substantial and growing portion of health care costs, the FDA says.

The US has an abbreviated approval pathway to help provide patients with greater access to safe and effective biological products, it said. “This pathway helps reduce the time and cost of development without compromising safety and effectiveness.”

There is much at stake here, and naturally this contentious discussion echoes global trends. Just days ago, reports said Roche had sued Biogen in the US over alleged patent infringement involving biosimilar Tocilizumab, for instance.

Local civil society groups, in their letter to the departments of Health and Biotechnology, separately, called for removal of barriers in accessing biosimilar medicines.

The 2016 guidelines in India “necessitate that the marketing approval of biosimilars requires mandatory animal studies and comparative safety and efficacy studies,” the letter said. And this becomes a barrier for approval, as they are “resource intensive and time consuming,” it added.

This in turn limited the number of players entering the market, thus decreasing competition. Consequently, the steep price decline evident in generic drugs is not visible in biosimilar medicines, it pointed out.

The price of some of the biological therapies like monoclonal antibodies (used in cancer treatment) range from ₹2 lakh to ₹3.39 lakh per cycle and the cost for gene therapies is exorbitantly high, it added.

Global waivers

The letter points out that the last two years saw several global regulatory bodies reduce barriers to bring down the prices of biosimilars.

The examples they cite include, the UK regulator (MHRA) waiving both animal studies and comparative efficacy trials for the approval of biosimilars (2021), the World Health Organization replacing SBP (Similar Biotherapeutic Products) Guidelines with revised Biosimilar Guidelines, (2022), among others. In December 2022, the US President signed a legislation that removed animal studies requirements for biosimilar marketing approval. Similarly, Health Canada also does not require animal studies for biosimilar approval, it said.

Patient safety

Bejon Kumar Misra, Founder and Director of Patient Safety and Access Initiative of India Foundation, however, maintains that clinical trials and safety/efficacy studies are critical to ensure products are safe and efficacious. “The safety of patients cannot be compromised for the sake of affordability,” he says, stressing the need for stringent regulation.

The Indian biopharma industry is “already struggling to keep up with international quality and testing standards, given the existing regulatory inadequacy,” he cautions.

Anurag S Rathore, Professor, Department of Chemical Engineering at IIT Delhi, does not disagree with waiving animal trials, aligning with global regulatory systems. But waiving comparative trials, he says, may not apply for complex products where the impact is not fully understood. Comparative studies safeguard patient interest. While competition can be encouraged to bring down prices, he says, quality and safety requirements should not be diluted.

A comparative study can help map differences on how a product works in a local population, says Dr Amitav Banerjee, Professor Community Medicine at Pune’s Dr DY Patil Medical College and Chair - Institutional Ethical Committee at National Institute of Virology (ICMR,) and Armed Forces Medical College (AFMC- Pune). He calls for strong pharmacovigilance systems, enabling medical practitioners and patients to report adverse events linked to medicines.

Addressing apprehensions, Satyajit Rath, former scientist with the National Institute of Immunology, says, “making biosimilars accessible and affordable has nothing to do with diluting quality norms.” Rath, a Professor emeritus at Pune’s IISER, says that the suggestion to “rationalise” guidelines has been carefully thought-through. He was signatory to a global call by scientists (2019) to the WHO to revise guidelines. The guidelines have since been revised.