Biosimilar Development News

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Innovative Business Models Will Help The Oncology Biosimilar Market

    Oncology biosimilars are biologic agents that are highly similar to the originator biologic medicine, which is already approved by the U.S. FDA without clinically meaningful differences in terms of efficacy, safety, and purity with reference agents. Increasing the prevalence of cancer due to an unhealthy lifestyle and the rising number of U.S. FDA approvals of biosimilars are the factors boosting the oncology biosimilars market.

  8. Biocon Biologics & Just - Evotec Biologics Sign Licensing Deal For A Biosimilar Asset

    Biocon Limited (Biocon Ltd) and Evotec SE recently announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just - Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset.

  9. The Biosimilars Forum Applauds Congressmen Paul Tonko (D-NY) And Bob Gibbs (R-OH) For Introducing Legislation Mandating A CMS Star Ratings Program For Biosimilars

    Bipartisan introduction of legislation from Representatives Tonko and Gibbs will direct the U.S. Department of Health & Human Services (HHS) to create a biosimilar access measure in the Centers for Medicare & Medicaid Services’ (CMS) Star Ratings Program.

  10. Samsung Bioepis Presents Real-World Data Of BENEPALI(Etanercept) In Patients With Psoriasis At European Academy Of Dermatology And Venereology (EADV) Congress

    Samsung Bioepis Co., Ltd. recently announced real-world data of BENEPALI in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).