On March 1, 2023, Biogen Canada Inc. announced that BYOOVIZTM (ranibizumab injection), a biosimilar to Genentech’s LUCENTIS, is now available in Canada. BYOOVIZ is an anti-VEGF (vascular endothelial growth factor) therapy approved for the treatment of various eye disorders, including neovascular age-related macular degeneration (AMD). According to Biogen, AMD accounts…
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) has granted marketing authorization for XIMLUCI (ranibizumab), a biosimilar of LUCENTIS. XIMLUCI is an anti-VEGF (vascular…
On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved…
On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for XIMLUCI®. XIMLUCI® is a biosimilar candidate referencing LUCENTIS® (ranibizumab), which is an anti-VEGF (vascular endothelial…
On August 2, 2022, Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity. Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion…
In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments and recommendations in a General Advice letter received from FDA, “Xbrane plans to resubmit the [ranibizumab] BLA during 2022,” and that…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products. On June 23, 2022, CHMP recommended the grant of a marketing authorization for RANIVISIO (ranibizumab) to Midas Pharma GmbH. RANIVISIO references LUCENTIS® and, if approved, would be used to…
Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations. According to the press release, the reported revenues were mainly a result…
Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The United Kingdom is…
On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab). According to the press release, Formycon has acquired 100% of the rights in FYB202, a biosimilar candidate for STELARA®, and ATHOS’s 50% stake…