The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.
A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide); Celltrion completed its biologic license application for its omalizumab biosimilar candidate.
Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.