The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.

14 小时之前 · FDA Reviews Golimumab Biosimilar. The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech’s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and Simponi Aria), which treats inflammatory conditions like rheumatoid arthritis. 1 This is the first BLA for golimumab biosimilar to be accepted by the FDA.

Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes.

10 小时之前 · Psoriasis is a chronic immune-mediated inflammatory disease that impacts the skin, joints, and other organs that is estimated to affect over 60 million people of all ages worldwide. 2 Managing psoriasis requires long-term treatment, which can have a significant impact quality of life and pose a considerable social and economic burden. Reference adalimumab (Humira) is a widely used biologic for ...

2025年1月13日 · The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.

2 天之前 · The open-label, prospective, multicenter ECU-PNH-III-X study (NCT04679103) published in Acta Haematologica, was conducted as part of the clinical development process for Elizaria, with the cohort being recruited from a previous phase 3 clinical trial (NCT04463056) what demonstrated noninferiority of the biosimilar vs the originator (Soliris). PNH is a rare blood condition in which a portion of ...

January 13th 2025. The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.

2024年9月29日 · Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.

2024年11月14日 · The Impact of the Interchangeability Designation on Patient Biosimilar Access. On June 20, 2024, the FDA published updated draft guidance titled “Consideration for Demonstrating Interchangeability with a Reference Product: Update.” The guidance describes considerations regarding a switching study, or studies, intended to support that a biological product is interchangeable with the ...

2024年8月10日 · Artificial intelligence (AI) technologies can aid global health systems in incorporating biosimilars into care models, lower health care costs, aid in treatment decision-making strategies, and bridge the gap between high-income and low- and middle-income nations, according to a review published in Pharmaceuticals (Basel). 1. Conducted to address the evolving landscape of biosimilars following ...