Biosimilar Development News

  1. NeuClone Announces Positive Results From Phase I Study Of Stelara (ustekinumab) Biosimilar Candidate 10/20/2020

    NeuClone Pharmaceuticals Ltd (NeuClone) today announced its biosimilar candidate of Stelara (ustekinumab), NeuLara, has successfully met all primary and secondary endpoints in a Phase I clinical trial.

  2. ICER Publishes Final Report And Policy Recommendations For Targeted Immune Modulator Therapies For Ulcerative Colitis 10/16/2020

    ICER’s report on these therapies was reviewed at the September 2020 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees.

  3. Henlius And Essex Enter Into A Global Co-Development And Exclusive License Agreement, To Jointly Develop Bevacizumab To Treat Ophthalmic Diseases 10/15/2020

    Shanghai Henlius Biotech, Inc. announced that the company entered into a co-development and exclusive license agreement with Essex Bio-Investment and Zhuhai Essex (collectively called Essex), two wholly-owned subsidiaries of Essex Bio-Technology Limited (Essex Bio-Technology, 1061.HK). Pursuant to the agreement, Henlius agreed to co-develop its bevacizumab HLX04 indicated for ophthalmic diseases such as wet age-related macular degeneration (wAMD) with Essex and to grant an exclusive license to Essex to develop, manufacture and commercialize HLX04 in the field of human ophthalmic therapies globally.

  4. Global Pegfilgrastim Biosimilars Market Grows With Increased Prevalence Of Cancer 10/14/2020

    The rising prevalence of chronic diseases is expected to be a major driver of the pegfilgrastim biosimilars market. Long working hours, limited physical activity, unhealthy eating and drinking habits contribute people suffering from these to be more vulnerable to chronic diseases, thus driving the need for pegfilgrastim biosimilars.

  5. Humira Manufacturer’s Efforts To Block Generic Options Challenged In Court 10/12/2020

    The maker of Humira, the world's best-selling drug, faces a new legal challenge over alleged anticompetitive tactics. Monday, the U.S. Public Interest Research Group (U.S. PIRG) filed an amicus brief in the 7th Circuit Court of Appeals arguing that AbbVie’s strategies of reverse payment settlements and creating “patent thickets” have delayed the entry of biologically similar generic drugs (biosimilars) onto the market, costing Americans billions of dollars.

  6. New Data Presented At UEG Week Virtual 2020 Show Positive Association Between Remsima SC Pre-Dose Level With Efficacy Outcomes 10/10/2020

    Celltrion Healthcare today announced two new data sets relating to the use of the subcutaneous formulation of infliximab, Remsima SC (CT-P13 SC), in inflammatory bowel disease (IBD) at a poster presentation at UEG Week Virtual 2020.

  7. Cytiva’s Fibro PrismA Technology Accelerates mAb Purification In LifeArc’s Covid-19 Research 10/8/2020

    Cytiva, a global life sciences leader, made Fibro PrismA, the first product based on its new protein A fiber chromatography technology, available commercially earlier this year. The new technology is already accelerating research for customers and collaborators, such as LifeArc.

  8. Samsung Bioepis And Biogen Announce EMA Filing Acceptance Of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab) 10/6/2020

    Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).

  9. IQVIA Institute For Human Data Science Study: Biosimilars Reach Inflection Point – On Track To Reduce Drug Costs By $100B Over Next Five Years 10/6/2020

    Biosimilar medicine availability and use are growing and on track to reduce drug costs by $100B over the next five years, according to a new report from the IQVIA Institute for Human Data Science.

  10. Biosimilars Could Generate $100B In Savings Over Next Five Years, New Report Finds 10/6/2020

    A new report from the IQVIA Institute for Human Data Science has determined that biosimilars are on track to reduce drug costs by $100B over the next five years if their use rises. The future of this lower-cost drug market, however, is still uncertain.