Biosimilar Development News

  1. Plantform And Swiftpharma Target Blockbuster Cancer Drug With New Contract Manufacturing Agreement For Plant-Made Biosimilars 11/14/2023

    Canadian biopharmaceutical company PlantForm Corporation and Belgium-based SwiftPharma have signed a contract manufacturing agreement that will see SwiftPharma produce antibodies and proteins for PlantForm’s product pipeline.

  2. Lupin And Amman Pharma Sign Exclusive Licensing And Supply Agreement For Ranibizumab Biosimilar 11/10/2023

    Global Pharma major Lupin Limited (Lupin) has partnered with Amman Pharmaceuticals Industries (Amman Pharma), a leading pharmaceutical manufacturer with operations across the MENA region and other global markets, for exclusive marketing and commercialization of Ranibizumab, a biosimilar of Lucentis, in the Middle East region, including select territories of Jordan, Saudi Arabia, UAE, Iraq, Lebanon, and other GCC countries.

  3. STADA And Alvotech Receive Positive CHMP Opinion For Europe’s First Ustekinumab Biosimilar To Stelara 11/10/2023

    Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab).

  4. Sandoz Inaugurates New Antibiotic Production Plant In Austria And New Biosimilar Development Center In Germany 11/10/2023

    Sandoz, the global leader in generic and biosimilar medicines, has opened two new European facilities, in line with its ongoing plans to strengthen sustainable development and supply of critical medicines in Europe and beyond.

  5. Samsung Bioepis & Organon Announce FDA Acceptance Of Supplemental Biologics License Application (Sbla) For Interchangeability Designation For HADLIMA™ (adalimumab-bwwd), A Biosimilar To Humira® 11/7/2023

    Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for HADLIMA™ (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira® (adalimumab).

  6. Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars 11/3/2023

    Juliana M. Reed, executive director the Biosimilars Forum, released the following statement announcing the Biosimilars Forum’s support for the Senate Finance Committee’s latest legislative discussion draft.

  7. WHO-IGBA Meeting: Working Together To Support Global Access To Generic And Biosimilar Medicines 11/3/2023

    Generic and biosimilar medicines are critical to healthcare systems worldwide, supplying around 80% of medicines globally at about 25% of the cost of reference medicines1.

  8. Biosimilars Forum Announces Support For Bipartisan Interchangeability Legislation 11/2/2023

    Juliana M. Reed, executive director the Biosimilars Forum, released the following statement announcing support of the bipartisan interchangeability legislation. All biosimilars are fully vetted by the U.S. Food and Drug Administration (FDA) for safety and efficacy.

  9. Fresenius Kabi Launches Tyenne*, The First Approved Tocilizumab Biosimilar In The European Union 11/1/2023

    Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today the launch of its tocilizumab biosimilar Tyenne referencing RoActemra** (tocilizumab) in the European Union.

  10. FDA Approves Interchangeable Biosimilar For Multiple Inflammatory Diseases 10/31/2023