Tagged as: ranibizumab

Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

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STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

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…

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Genentech Voluntarily Recalls SUSVIMO (ranibizumab)

This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool.  SUSVIMO, which provides continuous administration of the anti-VEGF (vascular endothelial growth factor A) monoclonal antibody fragment ranibizumab, is approved by the FDA for treatment of wet age-related macular degeneration.  According to Genentech,…

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EMA Adopts Positive Opinion for STADA and Xbrane’s Ranibuzumab Biosimilar Candidate XIMLUCI®

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…

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EMA CHMP Recommends Three Biosimilars - Big Molecule Watch

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…

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Formycon Q1 2022 Financial Results - Big Molecule Watch

First Quarter Earnings Graphic

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…

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Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo.  Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and…

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FDA Approvals and Applications Update

On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in…

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Coherus and Xbrane Announce Acceptance of Regulatory Submissions for Ranibizumab Biosimilars

On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular degeneration (nAMD) and several other ophthalmic conditions. The BLA was originally submitted by Coherus’ partner, BioeqAG.  On October 4, 2021,…

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