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Biosimilars

Henlius Builds Profitability Streak With Second Year In The Black

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.

Dr Reddy’s Bags Rights To Two More Biosimilars In Deal With Bio-Thera

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.

Kabi Lines Up Denosumab Biosimilar Launch As FDA Says Yes To Filings

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.

Alvotech And Advanz Make First Omalizumab Filing

Alvotech and Advanz have announced a UK MHRA filing acceptance for their partnered AVT23 proposed biosimilar to Xolair (omalizumab).

AEON Eyeing FDA Meeting On Botox Biosimilar By The End Of 2025

With an ambitious goal to file a biosimilar to the world-renowned Botox brand via the US FDA’s 351(k) regulatory pathway, AEON Biopharma has revealed the latest steps in its plan.

‘Our Commitment Is Serious’: Fresenius Kabi’s CEO Pierluigi Antonelli On Biosimilars And Beyond

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

Regulatory Recap: Proposed FDA Head Makary To Advocate For Generics And Biosimilars

Generics Bulletin reviews global regulatory developments across the globe.

Alvotech Snaps Up Xbrane’s R&D And Cimzia Rival For $27m

Sweden’s Xbrane has struck a deal to transfer its R&D operations in Sweden and its Cimzia (certolizumab pegol) biosimilar candidate to Alvotech, in a transaction worth around $27m. However, Xbrane told Generics Bulletin that it was not getting out of biosimilar development altogether.

Alvotech And Reddy’s Await US Denosumab Decision As Launch Date Closes In

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

IGBA’s Susana Almeida On Consensus Building, Harmonization, And Policy Built On Science – Not Politics

IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.