Generics & Biosimilars
In the US, the launch of competition to Humira was a pivotal event in the biosimilars sector in 2023, accompanied by key developments such as settlements on Stelara and the first approvals for biosimilars of ustekinumab, natalizumab and tocilizumab.
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In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.
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The launch of competition to Humira was the main event for US biosimilars this year – but a number of other key developments also took place in 2023, including settlements on Stelara that set up a series of launches in 2025, as well as first approvals for ustekinumab, natalizumab and tocilizumab biosimilars.
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“A lot of companies are hurting because of the higher interest rates,” one major CEO observed recently, summing up a year which saw little headline-grabbing news on the M&A front for generic and biosimilar sponsors.
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Repurposing licensed drugs can be an affordable and effective way to bring new treatments to market, but initial efforts tend to lack funding from big pharma. In Vivo takes a closer look at repurposing projects across the central nervous system space, what it is that drives the work forward and how innovative trial design is changing the game.