Biosimilar Development News

1. Organon Secures US Food And Drug Administration Approval Expanding Indications For TOFIDENCE (tocilizumab-bavi) In Cytokine Release Syndrome (CRS) And Pediatric COVID-19 6/10/2026

   Organon today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab).

2. Bio Techne And Refeyn Close Critical Gap In Bispecific Antibody And Biosimilar Characterization 6/4/2026

   Bio‑Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents and diagnostic products, and Refeyn, the pioneer in mass photometry technology, today announced a first‑of‑its‑kind integrated workflow for the characterization of charge and size variants in bispecific antibodies and biosimilars.

3. Alvotech Announces Resubmission Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria®, And AVT06, A Proposed Biosimilar To Eylea® 6/4/2026

   Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the resubmission to the U.S. Food and Drug Administration (FDA) of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab), and AVT06, a proposed biosimilar to Eylea® (aflibercept) 2 mg.

4. AEON Biopharma To Present Data Demonstrating Structural And Functional Comparability Of ABP-450 To BOTOX® At The 68^th Annual Scientific Meeting Of The American Headache Society 6/4/2026

   AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced the presentation of new analytical and functional data supporting biosimilarity of ABP-450 to BOTOX® at the 68^th Annual Scientific Meeting of the American Headache Society (“AHS”), being held June 4-7, 2026 in Orlando, Florida. 

5. Kashiv BioSciences Announces Validation And Acceptance Of Market Authorization Application By Health Canada For ADL-018, A Proposed Biosimilar To XOLAIR (omalizumab) 6/4/2026

   Kashiv BioSciences, LLC (“Kashiv”), a vertically integrated biopharmaceutical company, today announced that Health Canada has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company’s proposed biosimilar for XOLAIR (omalizumab).

6. PBIRx Hosts Webinar: Biosimilars - The New Savings Frontier For Prescription Drug Benefits 6/4/2026

   While biosimilars offer up to 90% savings over their specialty drug counterparts, uptake in the U.S. has been slow. PBIRx, a national leader in pharmacy benefit consulting and auditing, hosted an insightful webinar today, Biosimilars: The New Savings Frontier, providing actionable insights into the biosimilar market landscape, regulatory influences, and PBM strategies for plan sponsors.

7. Lupin Receives Approval From U.S. FDA For Ranluspec™ (ranibizumab) Injection 6/4/2026

   Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).

8. Teva Expands European Biosimilars Portfolio With Launch Of AHZANTIVE® (aflibercept) Biosimilar To Eylea® 6/4/2026

   Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of AHZANTIVE (aflibercept), a biosimilar to Eylea®, in Europe further strengthening the Company’s growing biosimilars portfolio and expanding its presence in ophthalmology.

9. Rezon Bio Appoints Dr. Ralf Otto As Chief Operating Officer To Support Next Phase Of Growth And Operational Expansion 6/3/2026

   Rezon Bio, a science-driven European biologics contract development and manufacturing organization (CDMO), today announced the appointment of Dr. Ralf Otto, as Chief Operating Officer (COO) effective June 1, 2026.

10. Chime Biologics And Daewoong Pharmaceutical Enter Strategic Partnership To Advance Dupilumab Biosimilar Development And Commercialization In Global Markets 6/2/2026

    Chime Biologics, a global biologics CDMO dedicated to enabling partners’ success, and Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, today announced the signing of a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Dupixent.