It is that time of year when everyone starts reflecting on learned lessons and achieved goals – including us at Generics Bulletin and the wider off-patent drug sector. In this end-of-year review, we look at biosimilars, which surely have made their presence known throughout 2024.
Biosimilar Year In Review: Regulatory Achievements And Future Aspirations
Industry Stakeholders Share Their Most Notable Biosimilar Regulatory Developments In 2024
This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.
More from Biosimilars
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.
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With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.
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India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.
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Fresenius Kabi has met its end of the bargain to launch biosimilars to Prolia/Xgeva in the middle of this year, after bagging FDA approvals. The German firm is also set to hear back on its filings in Europe imminently.
More from Generics Bulletin Perspectives
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GLP-1 drugs like Ozempic and Mounjaro have shaken up pharma, crossing firmly over into the mainstream while netting fortunate suppliers billions of dollars in the process. As patent expiry approaches for first- and second-generation products, generics manufacturers are gearing up to take a share of the spoils.
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This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.
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Generics Bulletin's editorial team discusses key topics from the year, including the latest rankings of the Generics Bulletin Top 50, Amgen’s surprise launch of a US Eylea biosimilar, the EU’s Urban Waste Water Treatment Directive and supply-chain issues for the off-patent sector.