Patient groups urge Centre to remove access barriers to biosimilars

Patient groups have urged the Centre to remove barriers in accessing biosimilar medicines.

“The Indian Biosimilar Guidelines, necessitate that the marketing approval of biosimilars requires mandatory animal studies and comparative safety and efficacy studies,” said a letter addressed to the Departments of Health and Biotechnology.

“These two requirements acted as a major barrier for the approval of biosimilars since they are resource intensive and time consuming,” it said.

“The presence of these barriers limits the number of players entering the market, thus decreasing competition. Consequently, the steep price decline that is evident in case of generic drugs is not visible in the biosimilar medicines,” they added.

Over the last two years, several regulatory bodies across the globe had reduced these barriers to bring down the prices of biosimilars, they pointed out.

Global waivers

In 2021, the UK’s regulator (MHRA) waived both animal studies and comparative efficacy trials for the approval of biosimilars.

In 2022, the World Health Organization replaced SBP (Similar Biotherapeutic Products) Guidelines with revised Biosimilar Guidelines, the letter said.

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Outlining some of the important developments in 2022, they said that the Biosimilar Guidelines issued by the WHO included a revised approach to clinical comparability requirements, obviating the need for animal studies.

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, they said.

Exorbitant cost 

“Biologics are the fastest-growing class of medications and account for a substantial and growing portion of health care costs. However, the price of some of the biological therapies like oncology monoclonal antibodies range from ₹2 lakh to ₹3.39 lakh per cycle and the cost for gene therapies is exorbitantly high,” they said.

The Health Ministry’s National Policy for Rare Diseases, 2021 also recognises the high cost of medicines for rare diseases, and the “severely limited” access to them.

The incorporation of the new revised WHO Biosimilar Guidelines in the Indian regulatory framework presents tremendous opportunities for manufacturing to introduce affordable, safe and efficacious biosimilars, they said.

“The waving of comparative efficacy studies and in-vivo animal toxicity studies will drive down the cost of production of biosimilars. Significant savings from streamlined biosimilar development can be achieved while maintaining the safety and efficacy of the biosimilar product. This will facilitate affordability and access of biotherapeutic products to patients in need of such treatments,“ the group said.

The letter urged the Centre to take steps to revise the Biosimilar Guidelines, 2016 and facilitate access to quality biosimilars at an affordable price.

The group has also urged the government to form a committee “free from the influence of innovator biologic manufacturers who have a clear conflict of interest promoting the originator products which are exorbitantly priced and clearly out of reach of most Indian people”.

The letter was signed by the All India Drug Action Network, All India Peoples Science Network, CureSma Foundation, Delhi Network of Positive People, Drug Action Forum (Karnataka), Initiative for Health & Equity in Society, Jan Swasthya Abhiyan, Working Group on Access to Medicines and Treatments and World Without GeneMyopathy.