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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Viatris has provided an update on its biosimilar pipeline, covering assets including insulin glargine, insulin aspart, aflibercept and bevacizumab, as part of its second quarter strategic update.
Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.
Celebrating a “major milestone in the biosimilar clinical development programs,” Gan & Lee has just presented positive data at the recent at the Scientific Sessions of the American Diabetes Association.