The Center for Biosimilars

A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation. https://bit.ly/3BIIEU9

Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product. https://bit.ly/4iSM2Nh

Elie M. Bahou, Pharm.D., M.B.A., senior vice president and system chief pharmacy officer at Providence, discussed barriers to biosimilar adoption and highlighted strategies such as physician education, streamlined implementation, payer collaboration, and patient engagement to improve access, reduce costs, and enhance adherence to biologic therapies. https://bit.ly/3ZWZ059

Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications. https://bit.ly/3VyGJZi

The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD. https://bit.ly/41xysIJ

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar. Read all the details: https://bit.ly/3ZRovEH

Biosimilars Weekly Recap! Check out the full video, including all of these articles, in the link below: https://bit.ly/3ZPV1ao

The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes. https://bit.ly/3VAdTYy

Steve Pickette, PharmD, BCPS, emphasizes that AI can streamline prescribing and formulary management for biosimilars and generics, enhance provider engagement, and improve pharmacovigilance by tracking adoption rates and identifying potential issues. https://bit.ly/3BuLHPG

The #340B program, with its lack of oversight and transparency, allows #hospitals and #contractpharmacies to profit—while the patients it was designed to help are left behind. In RealClearHealth, William Smith, PhD, and I discuss how #IRA price controls could worsen these abuses. #Healthcare #PatientAccess #Pharma https://bit.ly/IRA340B Global Healthy Living Foundation Progressive Policy Institute