Biosimilar Development News

1. FDA Approves First Interchangeable Biosimilar Insulin Product For Treatment Of Diabetes 7/29/2021

   Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

2. Viatris Inc. And Biocon Biologics Receive Historic Approval For First Interchangeable Biosimilar Semglee® (Insulin Glargine-yfgn) Injection For The Treatment Of Diabetes 7/28/2021

   Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

3. Abzena And BioXpress Therapeutics Announce Partnership To Support The Development And Manufacture Of Biosimilars For Global Customers 7/27/2021

   Abzena, a Global Partner Research Organization for integrated bench to patient solutions for biologics and bioconjugates, and BioXpress Therapeutics, a world-class leading developer of high quality, monoclonal antibody (mAb) biosimilar therapeutics have announced their partnership to support biosimilar development for third party customers.

4. Intas Enters Into An Exclusive License Agreement With Meiji And Dong-A ST To commercialize DMB-3115 (Proposed Biosimilar To Ustekinumab) 7/22/2021

   Intas Pharmaceuticals Ltd continues to pledge their commitment to increasing access to high quality medicines by entering into an exclusive license agreement with Meiji and Dong-A Socio Holdings (a parent company of Dong-A ST) to commercialize DMB-3115, a proposed biosimilar to ustekinumab, a recombinant monoclonal antibody for the treatment of autoimmune and inflammatory diseases such as plaque psoriasis, Crohn's disease and ulcerative colitis.

5. Samsung Bioepis Begins Phase 3 Clinical Trial For Stellara Biosimilar (SB17) 7/20/2021

   According to the information published on the global clinical trial information website 'clinicaltrials.gov' on the 19th, Samsung Bioepis has been offering 464 patients with moderate and high severity levels in 8 countries, including Poland, the Czech Republic, and Korea, since July this year.

6. First Patient Dosed in Phase 1 Clinical Trial Of Henlius Bevacizumab HLX04-O 7/19/2021

   Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient was dosed in a Phase 1 clinical trial in China for HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody injection jointly developed by the Company and Essex, for the treatment of wet age-related macular degeneration (wAMD).

7. Bio-Thera Solutions Announces The First Patient Dosed In Phase III Clinical Trial For BAT2206, A Proposed Biosimilar Of Stelara (Ustekinumab) 7/15/2021

   Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara (ustekinumab).

8. Food & Drug Administration Takes Strong Enforcement Action Against Biosimilar Misinformation 7/15/2021

   The Biosimilars Forum applauds the Food & Drug Administration’s (FDA) enforcement action this week against a company for misleading communications about biosimilars.

9. Menagen-MiddleEast Announces Commercializing Agreement With CKD For Biosimilar Darbepotein Alfa 7/12/2021

   Menagen Pharmaceutical Industries (“Menagen”) and Chong Kun Dang Pharmaceutical Corp (“CKD”) Korea announced today that they have entered into a strategic partnership in the GCC market for the technology transfer and commercialization for the first biosimilar Darbepoetin alpha, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. The CKD biosimilar is currently approved in South Korea.

10. President Biden’s Executive Order To Support Biosimilar Drugs Will Provide Lower Cost Options For Patients 7/9/2021

    The Biosimilars Forum applauds President Biden’s directions to the U.S. Department of Health and Human Services “to increase support for generic and biosimilar drugs, which provide low-cost options for patients” in his Executive Order Promoting Competition in the American Economy.