Challenges in the Adoption of Biosimilars in India

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Jayachandran , Jayalakshmi Punchaparamban
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The main aim of this research was to identify the main challenges faced by the pharmaceutical companies of India for the adoption of biosimilar drugs in the most recent scenario. Although there are several factors affecting the wide development and usage of biosimilars, in this study it was found that the lack of consumer or patient awareness followed by concerns on the safety and efficacy of biosimilars and lastly the lack of physician education and the inadequate regulatory framework for their development and approval. It was also noted that most of the study participants believe that India has a promising future for biosimilar drugs and the market is attractive for investment. The primary methodology of the study was quantitative survey which was carried out among 158 random pharmaceutical professionals of India to get their insights on the factors hindering on biosimilars. In addition, market analysis was carried out to provide comprehensive understanding of biosimilar landscape in India and a case study on a safety incident of biosimilar product approved in India showed how a more streamlined regulatory network could help in raising the quality of biosimilar drugs to other international standards. The multiple linear regression was carried out on the collected survey data and the findings showed there is no significant relationship between the experience of pharmaceutical professionals to the knowledge on biosimilar products and to the willingness to adopt a biosimilar product. Inorder to overcome the barriers, public education initiatives, trainings for healthcare professionals and conducting thorough pharmaceutical surveillance for analyzing the safety and efficacy of biosimilars can be carried out. Overall, by identifying and examining the key challenges, this research adds to the ongoing discussions about the adoption of biosimilars in India. The outcomes can guide future policy choices and strategic actions aimed at encouraging the widespread use of biosimilars, which will ultimately result in improved access to reasonably priced and high-quality biologic therapies in India.

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