Biosimilar Development News

  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. FDA Approves Samsung Bioepis' HADLIMA (adalimumab-bwwd)
    7/24/2019

    Samsung Bioepis Co., Ltd. recently announced that the US Food and Drug Administration (FDA) has approved HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the full indications and Boxed Warning for HADLIMA.

  7. FDA Approves Pfizer’s Biosimilar, RUXIENCE (rituximab-pvvr), For Certain Cancers And Autoimmune Conditions
    7/23/2019

    Pfizer Inc. recently announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

  8. Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis
    7/23/2019

    Sandoz, a Novartis division and a global leader in biosimilars, today announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar denosumab.

  9. Baxter Announces U.S. FDA Approval Of Myxredlin, The First And Only Ready-To-Use Insulin For IV Infusion
    7/22/2019

    Baxter International Inc., a global leader in sterile medication production and delivery, recently announced the U.S. Food and Drug Administration (FDA) approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection).

  10. Celltrion And Nan Fung Group To Establish Vcell Healthcare Limited To Develop And Commercialize Biosimilars In China
    7/18/2019

    Celltrion and Nan Fung Group announced today the establishment of Vcell Healthcare Limited, a Joint Venture company between both parties.