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Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Hukyndra And Libmyris Biosimilar Rivals To Humira Endorsed By EMA’s CHMP

 
• By Dave Wallace

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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The EMA’s CHMP Has Endorsed Alvotech’s biosimilar • Source: Alamy

Alvotech and Stada look set to win the second ever approval for a higher-strength biosimilar version of Humira (adalimumab), after the Committee for Medicinal Products for Human Use within the European Medicines Agency adopted a positive opinion on Alvotech’s AVT02 candidate recommending granting a pan-European marketing authorization under the names Hukyndra and Libmyris.

Available as a 40mg solution for injection in a pre-filled syringe and pre-filled pen, as well as an 80mg solution for injection in a pre-filled syringe, Hukyndra and Libmyris – filed via Stada – were both recommended for approval with the same indications: rheumatoid arthritis; juvenile idiopathic arthritis; axial spondyloarthritis; psoriatic arthritis; psoriasis; pediatric plaque psoriasis; hidradenitis

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