The Current Status and Future Perspectives on Biosimilars in India

The outlook for the use and integration of biosimilars into the Indian market holds promise for reducing treatment costs and improving accessibility, a newly published review indicated.

The paper, published in The Journal of Pharmacy and BioAllied Sciences, outlines the expected potential benefits of biosimilars, as well as the history and trajectory of future trends. The authors noted that modern policy framework for approving biosimilar products began in earnest when the European Union formulated the framework, and upon applying it and approving the first biosimilar (Omnitrope) in 2006. The United States followed nearly a decade later in 2015 with a biosimilar for filgrastim (which the FDA had approved in 1991) and has continued to approve a number of biosimilars for cancer, as well as other conditions. The latest biosimilar approved in the United States was approved in 2018. According to the researchers, there are now “multiple biosimilars developed by biopharmaceutical companies and used across the world for wide range of areas such as diabetes, ophthalmology, and respiratory to cancer and connective tissue diseases.”

The authors singled out India as a particular example of the thriving biosimilar ecosystem, noting that India is home to over 100 biopharmaceutical companies that manufacture and market biosimilars. India approved its first biosimilar in 2000 for hepatitis B at a time when there were no specific guidelines for the development and marketing of biosimilar products. One Indian manufacturer recently received FDA permission for marketing a novel biologic (Herceptin), which is used in the treatment of stomach cancer. It was the first Indian biosimilar approved for marketing in the United States.

There remains, according to the researchers, no specific guidelines for what are called “similar biologics” in India, despite India being on the forefront of manufacturing the products. This has led to delays in the process, as more data are called for biosimilars in some cases than for generic drugs under this system. More recent changes to the system have been implemented, beginning in 2016. A regulatory overhaul improved the process beginning in 2012 and continuing with more changes in 2016. Prior to 2012, it was “essential” for the biosimilar being manufactured for the biosimilar be developed and marketed in India; this has been changed to India or any other international council for harmonization countries.” It also change the requirements for post-marketing studies, and added additional safety and efficacy study requirements.

The researchers also touch on future perspectives. They note that when certain drugs come off patent in coming years, it could present a window of opportunity for India, which has been in the biosimilars business longer than anybody.

“India has the potential to become a global player in similar biologics or biosimilars,” the authors said in their paper. “According to ASSOCHAM-Sathguru report released in 2016, biosimilar presents a $240-billion global opportunity to Indian biopharmaceutical industry and the domestic market is expected to grow $40 billion by 2030.”

Read more at The Journal of Pharmacy and BioAllied Sciences