Biosimilar Development News

1. BD And Mitsubishi Gas Chemical Have Signed A Letter Of Intent (LOI) To Discuss A Partnership Agreement To Explore New Ways To Advance Biologic Drug Delivery 5/19/2022

   BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Mitsubishi Gas Chemical Company, Inc. (MGC), a R&D-oriented chemical manufacturer based in Tokyo, Japan, today announced that they have entered into an agreement to investigate further development of OXYCAPT™ - an innovation from MGC that integrates the best of plastic and glass for plastic syringes.

2. Viatris And Biocon Biologics Launch Abevmy® (Bevacizumab), Their Third Oncology Biosimilar, In Canada 5/19/2022

   Viatris Inc. and Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced today that Abevmy® (bevacizumab) is now available in Canada. Abevmy, co-developed by Viatris and Biocon Biologics, is a biosimilar to Roche's Avastin® (bevacizumab) and has been approved by Health Canada across four oncology indications.

3. United Kingdom First To Grant Licence For Teva’s Ophthalmology Biosimilar Ongavia (ranibizumab) 5/17/2022

   Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab ), an eye injection.

4. Alvotech Announces Positive Results From A Pharmacokinetic Similarity Study For AVT04, A Proposed Biosimilar To Stelara 5/16/2022

   Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab).

5. JSR Life Sciences Launches 'Similis Bio' To Help Partners Accelerate Biosimilar Development 5/10/2022

   JSR Life Sciences, LLC (JSR) today announced the launch of a new business division, Similis Bio (Similis), which will operate a partnering program designed to help biopharmaceutical companies improve the efficiency and cost of biosimilar development. 

6. Formycon AG AND ATHOS KG Announce Closing Of Transaction To Acquire Biosimilar Assets FYB201 And FYB202 As Well As Bioeq GmbH 5/10/2022

   Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announce the closing of the acquisition of the biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH ("Bioeq") with the registration of the implementation of the non-cash capital increase in the commercial register after the occurrence of all necessary conditions and the approval of the required authorities.

7. FDA Approves Alymsys® (bevacizumab-maly), A Bevacizumab Biosimilar Developed By mAbxience 5/2/2022

   Brand Institute is proud to announce its successful partnership with mAbxience in the development of the ALYMSYS® brand, under which the Food and Drug Administration (FDA)-approved biosimilar on 13 April 2022 will be marketed by Amneal Pharmaceuticals LLC.

8. First Subject Dosed In Phase 3 Clinical Trial Of Pertuzumab Biosimilar HLX11 4/28/2022

   Shanghai Henlius Biotech, Inc. announced that the first subject has been dosed in phase 3 clinical trial of the company’s pertuzumab biosimilar HLX11, a recombinant anti-human epidermal growth factor receptor 2 (HER2) subdomain II humanized monoclonal antibody injection, for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer.

9. Biosimilar Drugs - BIOJAMP(MC) And Accessa Join Forces To Simplify Access To Simlandi(MC) 4/27/2022

   BIOJAMPMC, the new biosimilars division of Canadian pharmaceutical company JAMP Pharma Group, is proud to partner with Accessa, an initiative of the Association québécoise des pharmaciens propriétaires, to facilitate access to SimlandiMC, which is used to treat certain inflammatory diseases affecting the joints, skin, digestive tract, intestines or eyes.

10. IND Application For Phase 2 Clinical Trial Of Serplulimab In Combination With Bevacizumab And Anti-EGFR mAb For The First-Line Treatment Of HCC Was Approved By The NMPA 4/20/2022

    Shanghai Henlius Biotech, Inc. announced that the investigational new drug application (IND) for a phase 2 clinical trial of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the Company, in combination with HANBEITAI (bevacizumab biosimilar) and HLX07 (innovative anti-EGFR mAb) for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). Previously, 9 immuno-oncology trials have been conducted on serplulimab.