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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Alvotech has highlighted the significance to its global development strategy of the EU’s recent approval of its AVT02 higher-strength adalimumab biosimilar. However, one month on from approval, European marketing partner Stada has yet to confirm launch plans.
Following delays caused by the COVID pandemic, Róbert Wessman, founder and principal shareholder in the Alvo group of pharmaceutical companies, has formally opened the new London offices of his investment fund Aztiq at a ceremony in Hammersmith.
With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.