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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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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Denosumab Biosimilar

Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.  According to Alvotech, the results from this trial will be…

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FDA Workshop on Sept. 19, 2022: Increasing the Efficiency of Biosimilar Development Programs

The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.”  The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.”  The workshop will include detailed discussion on the statistical methods…

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Sandoz & Polpharma Announce FDA and EMA Acceptance of Applications for Natalizumab Biosimilar

Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®.  The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS).  The application is for an intravenous…

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Alvotech Debuted on Nasdaq - Big Molecule Watch

Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively.  The debut on Nasdaq follows completion of the company’s business…

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Organon and Henlius license agreement - Big Molecule Watch

Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab).  According to the press release, Henlius independently developed both biosimilar products.  Organon will acquire exclusive global commercialization rights except for China.  The agreement…

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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

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Henlius and Eurofarma Entered into a License Agreement for Henlius' 3 Products in Latin America

Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company, for the development, manufacturing and commercialization of three biosimilar products in 16 Latin American countries. The three products are HANLIKANG® (rituximab), HANQUYOU®…

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