Biosimilar Development News

  1. WHO Signs MoU With International Generic And Biosimilar Medicines Association To Promote Access

    Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market.

  2. Alvogen Announces Exclusive Commercialization Agreements In South Korea, Israel And Canada For Teriparatide (PF708)

    Alvogen, recently announced new exclusive commercialization agreements with PharmBio in South Korea, Kamada in Israel and Jamp in Canada for Teriparatide (PF708) Forteo, the therapeutic equivalent for the treatment of osteoporosis.

  3. Biogen And Samsung Bioepis To Present Data For Infliximab And Adalimumab Biosimilars At United European Gastroenterology Week

    Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis today announced that they will present new real-world data from the companies’ anti-TNF biosimilar portfolio, which includes FLIXABI™ (infliximab) and IMRALDI™ (adalimumab).

  4. New Subcutaneous Formulation Of Celltrion Healthcare’s CT-P13 (Biosimilar Infliximab) Shows Positive Phase 1 Results For The Treatment Of IBD In Data Presented At UEG Week Barcelona 2019

    Celltrion Healthcare recently announced new data from a Phase 1 pivotal study to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 SC compared to the CT-P13 IV formulation in people with inflammatory bowel disease (IBD). Results presented at UEG Week 2019 in Barcelona, Spain demonstrated non-inferiority of CT-P13 SC compared to CT-P13 IV in the PK primary endpoint at pre-dose level (Ctrough) at week 22, and in the secondary endpoints efficacy and safety up to week 30.

  5. The Biosimilars Forum Applauds Launch Of New FDA Performance Dashboard

    We applaud the FDA for launching its new Biosimilar User Fee Act (BsUFA) performance dashboard that provides transparent information on the development and performance of biosimilars.

  6. NeuClone Announces First Human Dose Of Stelara (Ustekinumab) Biosimilar Candidate In Phase I Clinical Trial

    NeuClone, a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, recently announced it has commenced dosing of Stelara® (ustekinumab) biosimilar candidate, NeuLara, in a Phase I clinical trial.

  7. Pfenex Reports Positive Results For PF708 Comparative Use Human Factors Study

    Pfenex Inc. (NYSE American: PFNX) announced today it has successfully completed the PF708 comparative use human factors (HF) study and submitted the final study report to the FDA. The study found that the user interface of the FDA-approved PF708 product was noninferior to that of Forteo® for each critical user task evaluated in the study.

  8. Pfenex Provides Update For PF708 Outside The United States

    Pfenex Inc. (NYSE American: PFNX) today announced that its partner Alvogen has entered into exclusive commercialization agreements for PF708 with PharmBio Korea in South Korea, JAMP Pharma in Canada and Kamada Ltd. in Israel.

  9. Brindisi Provides Bipartisan Solution To Bring Down Drug Costs For Americans

    Congressman Anthony Brindisi continued his efforts to bring down drug costs by joining Reps. Scott Peters (CA-52) and Pete King (NY-02) to introduce the bipartisan Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act.

  10. ISOPP Global Position On The Use Of Biosimilars In Cancer Treatment And Supportive Care

    Although biosimilars lack clinically meaningful differences in therapeutic activity as compared to the originator product, these complex biological molecules are not considered identical chemical copies, unlike generics, and minor differences in molecular structure and inactive compounds may exist.