Viatris’ Insulin Aspart Endorsed By EMA
Kixelle Biosimilar Rival To NovoRapid Receives CHMP Positive Opinion
Viatris has received a positive opinion from the EMA’s CHMP recommending granting a pan-European marketing authorization for the firm’s insulin aspart biosimilar rival to NovoRapid.
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Viatris and partner Biocon have suffered a setback over their proposed insulin aspart biosimilar rival to NovoLog in the US, after the FDA issued a CRL relating to the filing.
Biocon and Viatris have landed their second biosimilar insulin approval in Europe, for a rival to Novo Nordisk’s NovoRapid (insulin aspart). Analyst reaction was lukewarm considering the “disappointing” launch of insulin glargine in Europe more than two years ago.
Biocon has secured the latest in a series of investments in its Biocon Biologics subsidiary, from Abu Dhabi based ADQ. The transaction, worth around $75m, values the biosimilars unit at $4.17bn.