NGOs ask govt to revise Biosimilar Guidelines to improve accessibility of quality biosimilars

Wednesday, July 12, 2023

Representatives of various civil society and community organisations related to the healthcare sector and patient groups in the country have come forward requesting the Central government to revise the Biosimilar Guideline of 2016 and address the major barriers for the approval of biosimilars so that quality products at affordable prices will be available to the public.

A letter addressing Rajesh Bhushan, Secretary to the Department of Health and Family Welfare and Rajesh S Gokhale, Secretary, Department of Biotechnology, was released by representatives of nine organisations said, “We would like to urge you to immediately take steps to revise the Biosimilar Guideline of 2016 and facilitate access to quality biosimilars at an affordable price. In this regard we would also request you 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 sent by 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.

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 Rs. 2 lakh to 3.39 lakh per cycle and the cost for gene therapies is exorbitantly high. The National Policy for Rare Diseases, 2021 from the ministry of health also recognizes the high cost of medicines for rare diseases. Hence access to these drugs is severely limited, they said.

For instance, obinutuzumab 1000mg/40ml from Roche has a maximum retail price of Rs. 3.99 lakh, atezolizumab 1200mg/20ml from Roche at Rs. 3.96 lakh and pembrolizumab 100mg/ml from MSD at Rs. 2.36 lakh, according to the non discounted price data available from online pharmacy website Pharmeasy, they said.

The current Indian Biosimilar Guidelines, necessitate that the marketing approval of biosimilar requires mandatory animal studies and comparative safety and efficacy studies. These two requirements are a major barrier for the approval of biosimilars since they are both resource intensive and time consuming. 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,” said the letter.

Since the last two years, several regulatory bodies across the globe have reduced these barriers to bring down the price of biosimilars in the market. In 2021, the UK MHRA waived both animal studies and comparative efficacy trials for the approval of biosimilars. In 2022, the WHO replaced its existing SBP Guidelines with revised Biosimilar Guidelines.

Some of the important developments in the 2022 Biosimilar Guideline issued by the WHO include - a revised approach to clinical comparability requirements, obviating the need for animal studies and a simplified approach to the sourcing of comparator products.
 
In December 2022 US President signed a legislation, which removed the animal studies requirements for biosimilar marketing approval. Similarly, Health Canada also does not require animal studies for biosimilar approval.

“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,” said the organisations.

“We understand that technical advancement in scientific technology and the remarkable improvements in increased knowledge from the elucidation of structure–function relationships, physiochemical and analytical characterization and the experience gained by regulators and developers, pave the way towards waving clinical evaluation, with a greater emphasis on assessment of quality and functional activities in vitro (nonclinical). The waving of comparative efficacy studies and in-vivo animal toxicity studies, will drive down the cost of production of biosimilars and 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,” they added.

PHARMABIZ.com