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Korea BioMed reported that Celltrion has submitted its application in EMA for CT-P39 (omalizumab), a biosimilar to Genentech/Novartis’ Xolair®.  The reference product Xolair® is approved in Europe for the treatment of asthma, chronic spontaneous urticaria and severe chronic...

Formycon AG announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara® (ustekinumab).  This follows Formycon’s report in August 2022 that its Phase III studies demonstrated the comparab...

STADA and Xbrane announced they are supplying  Ximluci® (a biosimilar to Roche/Genentech’s Lucentis® (ranibizumab)) in England under a NHS England Framework Agreement.   Ximluci® is indicated for the treatment of retinal vascular disorders, including wet age-related macular...

Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 (biosimilar to Eylea® aflibercept) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.  Samsung Bioepis reported that the safety, immunogenicity and PK profiles of SB15...

Xbrane has announced it has resubmitted its BLA for its investigational biosimilar to Genentech’s Lucentis® (ranibizumab) with FDA.  Xbrane expects that there will be a ten-month review process and its candidate could be approved during the first half of 2024.  In July 2022...

Samsung Bioepis announced that it will present new data on its SB15 (proposed aflibercept biosimilar) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on 23 and 24 April 2023, including 56-week results from its Ph III trials.

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Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® (dupilumab) as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies ...

The US District Court of West Virginia has issued a claim construction order pertaining to seven claims of the four patents asserted in Regeneron’s BPCIA case against Mylan.  The four patents in suit (US Patent Nos. 10,888,601, 11,084,865, 11,253,572, and 11,104,715) are di...