Global Biosimilars Market – Growing number of biosimilar approvals

A biosimilar is a biological product that is similar to a reference biologic in terms of potency, purity, and safety, with no clinically significant changes.

Global Biosimilars Market is estimated close to $18 Bn (2020) growing at a double-digit rate. The market growth is driven by increasing number of biosimilar approvals and growing number of biologics going off-patent.

Loss of patent protection for originator brands to drive the biosimilar growth

The number of loss of protection (LoP) events for originator brands will be a major factor in the expansion of the biosimilar market during the next 5-10 years. 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 key therapeutic areas in biosimilars market and by 2023, the patents on nearly 20 oncology biologics will expire, which might drive the entry of more biosimilars into the oncology space and propelling oncology biosimilars market.

Consistent growth in biosimilar approvals in the US 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 (only 3 approvals in 2020 impacted by COVID as shown in figure below). The growth of the US biosimilars market is being driven by the constant and consistent rise in the number of biosimilar approvals and market accessibility in the US. In 2015, only 1 biosimilar product was available for use in market and this number reached to 19 by end of 2020.

“There 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.” – CEO, Leading Biosimilars Company

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Geographic Snapshot: Biosimilars Market

Due to the adoption of more liberal policies that have increased market access, Europe is the largest market for biosimilars. However, the US has taken a more protective approach toward originator brands as a result of lobbying from pharma companies. Because of this, the adoption of biosimilars is somewhat delayed in the US. However, the US biosimilar landscape is now developing quickly. 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 advancements will fuel the US market growth.

Competitive Landscape: Biosimilars Market

Some of the key players in global biosimilars market include Amgen, Roche, Sandoz, Dr. Reddy’s, Teva, Pfizer, Eli Lilly, Samsung, Biocon, Boehringer, and Mylan.

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