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Latest From Formycon AG
Cimerli Interchangeable Biosimilar Approved Without Switching Data
Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.
Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis
Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.
Who’s Hired? Former Hikma Chief Olafsson Takes Lead At Mallinckrodt
Siggi Olafsson has taken the reins at Mallinckrodt after stepping down as Hikma’s CEO. At the same time, Teva has named a new global R&D and chief medical officer while Piramal Pharma Solutions has appointed a fresh COO and Formycon has added to its supervisory board.
BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
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