Biosimilar Development News

1. FDA Works To Ensure Smooth Regulatory Transition Of Insulin And Other Biological Products 2/20/2020

   Today, the U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March.

2. Celltrion Healthcare Showcases Positive 1-Year Results For Novel Subcutaneous Formulation Of Infliximab In Patients With Active Crohn’s Disease And Ulcerative Colitis Presented At The European Crohn's And Colitis Organisation (ECCO) Annual Congress 2/14/2020

   Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC).

3. Dr Andrew Ellis Appointed New BBA Chair 2/10/2020

   The British Biosimilars Association (BBA), the trade body representing the interests of biosimilar manufacturers, has welcomed Dr Andrew Ellis as its new Chair.

4. White House Budget Proposal Recognizes Urgent Need To Increase Patient Access To Lower-Cost Biosimilars 2/10/2020

   We are pleased that the president’s budget proposal again explicitly acknowledges that legislative changes to bolster the biosimilars market ‘would increase competition, reduce drug prices, and lower out-of-pocket costs for patients at the pharmacy counter.’

5. Merck To Focus On Key Growth Pillars Through Spinoff Of Women’s Health, Trusted Legacy Brands and Biosimilars Products Into New Company (‘NewCo’) 2/5/2020

   Merck, known as MSD outside the United States and Canada, today announced its intention to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company

6. Formycon Informs About The Current Status Of The BLA Review Process Of The Lucentis Biosimilar Candidate FYB201 2/5/2020

   Formycon AG and its licensing partner Bioeq AG ("Bioeq") announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the Biologics License Application (BLA) for the Lucentis(R) biosimilar candidate FYB201, submitted by Bioeq in December 2019.

7. President Trump Can Look To Biosimilars To Keep Promise Of Saving Americans Billions In Health Care Costs 2/4/2020
8. FDA And FTC Announce New Efforts To Further Deter Anti-Competitive Business Practices, Support Competitive Market For Biological Products To Help Americans 2/4/2020

   The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.

9. Bio-Thera Solutions Announces Positive Top-Line Results For BAT1706, A Proposed Biosimilar To Avastin 2/3/2020

   Bio-Thera Solutions, a commercial-stage biopharmaceutical company, today announced that the Phase III clinical trial comparing the safety and efficacy of BAT1706 versus Avastin1 (bevacizumab) met its primary endpoint.

10. Pfizer Receives Positive CHMP Opinion For Oncology Biosimilar, RUXIENCE (rituximab) 1/31/2020

    Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE (rituximab),¹ a potential biosimilar to MabThera (rituximab).2,3 RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).