Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
Hukyndra And Libmyris Biosimilar Rivals To Humira Endorsed By EMA’s CHMP
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.
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Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.
One part of a multi-pronged attack launched by AbbVie against Alvotech over the company’s proposed Humira (adalimumab) biosimilar has fallen, with a US district court stating that AbbVie’s US trade secrets lawsuit should be dismissed because it lacks a form of jurisdiction.
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.