Biosimilar Development News

  1. US Supreme Court denies Sandoz Petition To Review Biosimilar Erelzi® (Etanercept-szzs) Case 5/17/2021

    Sandoz, a global leader in biosimilar and generic medicines, today announced that the US Supreme Court has denied its petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi® (etanercept-szzs) for reference medicine Enbrel®* (etanercept). The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen’s patents.

  2. Xbrane Announces Ambition To Generate Positive Operating Cash Flow Monthly By Late 2023/Early 2024 And To Initiate One New Biosimilar Development Program Per Annum 5/16/2021

    Xbrane, Taking the next step in becoming a world-leading biosimilar developer, the company today announces its ambition to generate positive operating cash flow monthly on the back of expected Xlucane net-income by late 2023/early 2024 and to initiate one new development program annually.

  3. Alvotech Seeks To End Abbvie’s Wrongful Monopoly On Humira And Bring Affordable Arthritis Treatment To U.S. 5/11/2021

    Alvotech today filed a federal lawsuit (Case 1:21-cv-00589) seeking to end the monopoly that pharmaceutical giant AbbVie has long-maintained on the adalimumab market, sold as Humira. Humira is the highest grossing prescription drug in the United States with over $16B in sales in 2020 (nearly $20B globally).

  4. AMGEVITA®, A Biosimilar To HUMIRA®* (Adalimumab), Is Now Available In Canada For The Treatment Of Multiple Chronic Inflammatory Diseases 5/4/2021

    Amgen Canada today announced that AMGEVITA® (adalimumab, reference biologic drug: Humira®), is now available in Canada for the treatment of 11 chronic inflammatory conditions.

  5. Alberta Adds Humira Adalimumab To Biosimilar Switching Program 5/3/2021

    Biosimilars Canada today congratulated the Province of Alberta and Health Minister Tyler Shandro on the expansion of the province’s biosimilar switching program to include Humira adalimumab.

  6. Sandoz Confirms Late-Stage Clinical Development Plans For Proposed Biosimilar Aflibercept, A Key Ophthalmology Medicine 5/3/2021

    Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly.

  7. Samsung Bioepis Announces Analytical Similarity Data On SB11 (Ranibizumab) At The ARVO Annual Meeting 2021 5/1/2021

    Samsung Bioepis Co., Ltd. today announced results from a study analyzing structural and functional similarity between SB11, a proposed ranibizumab biosimilar, and Lucentis (ranibizumab). The study results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2021.

  8. Senators Cornyn And Bennet Introduce Bipartisan Legislation To Incentivize Biosimilars, Lower Cost For Seniors 4/30/2021

    Senators John Cornyn (R-TX) and Michael Bennet (D-CO) this week introduced the Increasing Access to Biosimilars Act (S. 1427) to enhance physician reimbursement when prescribing biosimilars, realigning incentives to increase utilization of lower-cost biosimilars in Medicare Part B and generate significant health care savings.

  9. President Biden Signs The Advancing Education On Biosimilars Act Into Law 4/30/2021

    The Biosimilars Forum thanks President Biden for his swift action in signing the Advancing Education on Biosimilars Act into law and looks forward to continuing to work with the administration to ensure that patients and providers have all of the educational resources and materials they need to be assured of the safety and efficacy of biosimilars.

  10. Valeo Pharma's Redesca® and Redesca HP® To Be Covered Under The Ontario Public Drug Benefit Program 4/28/2021

    Valeo Pharma Inc. (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, today announced that it has entered into a Product Listing Agreement ("PLA") with the Executive Officer of the Ontario Public Drug Program for the listing of Redesca® and Redesca HP®, its low molecular weight heparin ("LMWH") biosimilar, on the Ontario Drug Benefit Formulary effective April 30, 2021.