Biosimilar Development News

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. Amgen And Allergan's MVASI™ (bevacizumab-awwb) And KANJINTI™ (trastuzumab-anns) Now Available In The United States
    7/18/2019

    Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.).

  9. Uptake Of Biosimilars In The EU5 Blunts Share Of AbbVie's Humira And Merck's Remicade In The Crohn's Disease And Ulcerative Colitis Markets, While A Black Cloud Of Safety Concerns Still Follows Pfizer's Xeljanz
    7/16/2019

    According to the latest report published as part of Spherix's RealTime Dynamix™: Inflammatory Bowel Disease (EU) service, EU5 gastroenterologists (n=255) report rapid uptake of adalimumab biosimilars for the treatment of both Crohn's disease and ulcerative colitis (UC), with the biosimilar brands accounting for roughly one-tenth of biologic/JAK share for each market.

  10. New Issue Brief: Increased Use Of Biosimilars Could Bring Billions In Savings For Patients, Providers, Taxpayers
    7/11/2019

    Biosimilars have the potential to realize billions in savings for the health care system if reforms are enacted to incent their market share to grow, according to a new issue brief issued today by the Center for Medical Economics and Innovation at the California-based, free-market think tank, the Pacific Research Institute.