Biosimilar Development News

1. Amneal Announces U.S. FDA Filing Acceptance Of Biologics License Application (BLA) For Bevacizumab 6/17/2021

   Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Bevacizumab, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act).

2. The Biosimilars Forum Applauds SCOTUS Decision To Uphold ACA And US Pathway For Biosimilar Approval 6/17/2021

   Meaghan Rose Smith, Executive Director of the Biosimilars Forum, released the following statement following the Supreme Court’s decision in California v. Texas in which the Court voted to uphold the Affordable Care Act.

3. Alvotech Reaches Primary Completion Date In Its Switching Study For AVT02, A Proposed Interchangeable Biosimilar To AbbVie’s Humira 6/15/2021

   Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the company’s proposed interchangeable biosimilar to Humira.

4. New Report Shows Biosimilars Significantly Lowered Prices Of All Biologics 6/14/2021

   A new report from Xcenda demonstrates how biosimilars are significantly lowering the price of all biologics, or brand name reference biologics.

5. Celltrion Healthcare Presents The First Real-World Data For Truxima (Biosimilar Rituximab) In Patients With Diffuse Large B-Cell Lymphoma At The EHA 2021 Virtual Congress 6/12/2021

   Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.

6. Magellan Rx Management Oncology Biosimilar Solution Delivers $40M+ In Annualized Savings For Early Adopter Health Plans 6/9/2021

   Magellan Rx Management, a division ofMagellan Health, Inc., today announced annualized savings of over $40M for five health plan customers who were early adopters of its oncology biosimilar medical benefit drug management solution.

7. Theramex UK Ltd Announces A License And Supply Agreement With Enzene Biosciences Limited, For The Registration And Commercialisation Of Denosumab, An Antiresorptive Treatment For Osteoporosis, A Biosimilar Of Reference Medicine Prolia 6/9/2021

   Theramex, a leading global speciality pharmaceutical company dedicated to women and their health, announced that it has entered into an agreement to register and commercialise denosumab from Enzene Biosciences Limited, Pune, India, for use in Europe, the UK, Switzerland, and Australia.

8. Bio-Thera Solutions Initiates Phase III Clinical Trial For BAT2506, A Proposed Biosimilar Of Simponi (Golimumab) 6/8/2021

   Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).

9. Cytiva Acquires GoSilico To Strengthen Digital Capabilities In Bioprocessing 6/2/2021

   Global life sciences leader Cytiva has acquired the German scientific software maker GoSilico, in a move that will differentiate Cytiva as a premier partner in bioprocessing.

10. Lupin Announces U.S. FDA Acceptance For Pegfilgrastim Biosimilar Application 6/2/2021

    Global pharma major, Lupin Limited (Lupin) today announced that the U.S. FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.