Biosimilar Development News

  1. Richter Launched Terrosa®, Its Biosimilar Teriparatide Across Europe
    8/20/2019

    Gedeon Richter Plc. ("Richter") today announced that it has launched its biosimilar teriparatide, Terrosa® in Europe. The product is approved in adults for the same indications as Eli Lilly's Forsteo®, i.e. used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

  2. U.S. Biosimilars Market To Expand At 54.7% CAGR; Increasing Demand From The Unmet Populace To Create Growth Opportunities, Says Fortune Business Insights
    8/16/2019

    The U.S. Biosimilars Market will gain momentum from the increasing government support to adopt biosimilars in the healthcare sectors.

  3. Amgen Wins Patent Case On Enbrel® (etanercept)
    8/9/2019

    Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it.

  4. Sandoz Will Appeal District Court Of New Jersey Ruling In Biosimilar Erelzi® (etanercept-szzs) US Patent Case
    8/9/2019

    Sandoz, a Novartis division and a global leader in biosimilars, today announced that the United States District Court of New Jersey ruled against Sandoz in patent litigation concerning the Sandoz biosimilar, Erelzi® (etanercept-szzs) for reference medicine Enbrel®* (etanercept).

  5. OneOncology Is Early Adopter Of Biosimilars In U.S.
    8/8/2019

    OneOncology announced today that its partner practices have already begun administering two biosimilars from Amgen, MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), which were recently made commercially available in the United States.

  6. Biocon, Mylan Launch Ogivri In Australia
    8/2/2019

    Biocon Ltd. and Mylan N.V. have announced the launch in Australia of Ogivri (trastuzumab), a biosimilar to Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

  7. Coherus BioSciences Reports Victory In Pegfilgrastim Patent Dispute
    7/29/2019

    Coherus BioSciences, Inc. (“Coherus” or “the Company”, Nasdaq: CHRS), today announced that the United States Court of Appeals for the Federal Circuit has affirmed the decision of the United States District Court for the District of Delaware that Coherus’ UDENYCA® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar, does not infringe Amgen’s asserted patent.

  8. Alvotech And Cipla Gulf Enter Into A Partnership For The Commercialization Of Key Biosimilar In Select Emerging Markets
    7/29/2019

    Biopharmaceutical company Alvotech and Cipla Gulf FZ LLC ("Cipla Gulf"), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087) (NSE: CIPLA EQ; hereafter referred to as "Cipla"), today announced that Alvotech and Cipla Gulf have entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets.

  9. First Patient Dosed In A Clinical Trial Of Sintilimab And Anti-VEGF Monoclonal Antibody IBI305 In Combination With Chemotherapy In Patients With EGFR-Mutant Non-Squamous NSCLC Who Have Progressed From Prior EGFR-TKI Treatment
    7/25/2019

    Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, recently announced that the first patient has been dosed in ORIENT-31, a trial that evaluates Tyvyt (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody co-developed with Eli Lilly and Company, and IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, in combination with chemotherapy backbone in patients with EGFR-mutant non-squamous non-small cell lung cancer(NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

  10. First Patient Dosed In Sintilimab And Anti-VEGF Monoclonal Antibody IBI305 With Chemotherapy In Patients With EGFR-Mutant Non-Squamous NSCLC Who Have Progressed From Prior EGFR-TKI Treatment
    7/24/2019

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, today announced that the first patient has been dosed in ORIENT-31, a trial that evaluates Tyvyt® (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody co-developed with Eli Lilly and Company, and IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, in combination with chemotherapy backbone in patients with EGFR-mutant non-squamous non-small cell lung cancer(NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).