ALC - BioAgil

Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing costs while providing patients with broader access to critical medicines. The recent boom in the biosimilars market seen following a wave of blockbuster molecules coming off patent between 2015 and 2020 demonstrates the powerful allure of the potential of biosimilars¹. During this time, the market rapidly expanded at a compound annual growth rate (CAGR) of 78%¹.

3 key challenges facing the biosimilars space in 2023

In 2010, the biopharma industry saw an abrupt patent cliff: a significant number of top-selling drugs lost exclusivity. Once these originator products came off patent, the race was on between competing developers to gain approval first and reap the market share advantage. In the next eight years, 69 blockbuster drugs will lose exclusivity, setting the scene for yet another patent cliff and ensuing fight to be the first biosimilar to market.[1]