Biocon And Viatris Scoop EU Insulin Aspart Approval
Analyst Expects Biosimilar Penetration To Be ‘Slow And Minimal’
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.
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Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.
India’s Biocon has issued a response after a local English-language daily reported allegations that the company and one of its officials was involved in bribing the Joint Drugs Controller to waive Phase III clinical trial data for its proposed NovoLog (insulin aspart) biosimilar.
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.