A biosimilar is a biological product that is similar to a reference biologic with no clinically meaningful differences in terms of potency, purity, and safety.
Loss of patent protection for originator brands to drive the growth of the global biosimilar market
The key driver of biosimilar market growth over the next 5-10 years is the number of losses of protection (LoP) events for originator brands. In the US alone, 66 biologic U.S. patents are expiring between 2020 and 2025, owing to which the biosimilar market is on the cusp of a significant boost. Oncology is one of the major therapeutic areas in biosimilars market and by 2023, patents on nearly 20 oncology biologics will expire, which could lead to more biosimilars to enter in oncology space and propelling oncology biosimilars market.
Consistent growth in the biosimilar approvals in the US biosimilars market
The US biosimilars market is growing across multiple therapeutic areas. From 1 approval in 2015, the number of FDA approvals have increased to 10 in 2019. The steady and consistent increase in number of biosimilar approvals and market availability in US is driving the growth in the US biosimilars market. In 2015, only 1 biosimilar product was available for use in market and this number reached to 19 by end of 2020.
â€œThere is a huge potential for biosimilar market growth as they deliver significant benefits to the healthcare community. Biosimilars help augment overall treatment options, positively impact patients suffering from life-threatening conditions, whilst contributing to the quality and financial sustainability of healthcare systems.â€ â€“ CEO, Leading Biosimilars Company
Geographic Assessment: Global Biosimilars Market
Europe is the largest market for biosimilars owing to adoption of more liberal policies which has enabled greater market access. On the other hand, US has taken a more protective approach towards originator brands, further influenced by lobbying from pharma companies. Owing to this, the biosimilar adoption is relatively slower in US. However, the US biosimilar landscape is now evolving rapidly. There were 29 biosimilars approved in US compared to 11 in EU in the initial six years. Also, in April 2021, the US signed two bipartisan bills to reduce prescription drug prices by supporting generics/biosimilars. Such developments will fuel the US market growth.
The key players operating in the global biosimilars market are Amgen, Roche, Sandoz, Dr. Reddyâ€™s, Teva, Pfizer, Eli Lilly, Samsung, Biocon, Boehringer, and Mylan.
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