Alvotech is set to face a long-awaited US Food and Drug Administration reinspection of its Reykjavik facility in January, in a key milestone for the Icelandic firm that could pave the way finally to a US approval for its Teva-partnered AVT02 adalimumab high-concentration interchangeable biosimilar to Humira.
What’s Next? Five Things To Look Out For In January
Alvotech Waits On Pivotal FDA Inspection; JP Morgan Conference Hits San Francisco
Generics Bulletin previews the most noteworthy and anticipated events for January 2024.
More from Manufacturing
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.
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Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.
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Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.
More from Business
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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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The Chinese player reported its second profitable year in a row, with growth in sales reported across its marketed portfolio and further milestones in the near future.