Biosimilar Development News
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Blue Shield Of California Slashes Cost Of World's Best-Selling Drug
10/1/2024
Blue Shield of California today announced it has drastically cut the price it will pay for an FDA-approved biosimilar of blockbuster drug Humira – purchasing the medicine at a transparent net price of $525 per monthly dose, compared to the market reported net price of Humira at $2,100.
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Evio Announces Groundbreaking Direct Purchase Agreement For Adalimumab Biosimilar
10/1/2024
Evio Pharmacy Solutions, a Blues-founded company focused on transformational solutions in the high-cost medication space, today announced the successful negotiation and implementation of an innovative direct purchase agreement with Fresenius Kabi, an operating company of Fresenius, for Adalimumab-aacf — a lower priced biosimilar version of Humira.
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Fresenius Kabi And Formycon Receive U.S. FDA Approval For Biosimilar Otulfi* (ustekinumab-aauz)
9/30/2024
Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab).
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AEON Biopharma Announces Positive Outcome From FDA Biosimilar Advisory Meeting
9/30/2024
AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product.
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Primary Endpoint Met In Phase 3 Comparative Clinical Study Of Perjeta (pertuzumab) Biosimilar Candidate HLX11
9/30/2024
Shanghai Henlius Biotech, Inc. and Organon announced that the phase 3 comparative clinical trial for the investigational Perjeta (pertuzumab) biosimilar HLX11 met the primary endpoint.
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Otulfi*, Fresenius Kabi's Ustekinumab Biosimilar Developed By Formycon, Receives European Commission Approval
9/27/2024
Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the European Commission (EC) granted marketing authorization for its ustekinumab biosimilar candidate, indicated for the treatment of several serious inflammatory diseases.
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Xbrane Provides Update From Scientific Advice With US FDA On Xdivane (Opdivo Biosimilar Candidate)
9/27/2024
Xbrane Biopharma AB (publ) ("Xbrane" or the "Company") has received scientific advice from the US Food and Drug Administration (FDA) on the development of its Opdivo biosimilar candidate Xdivane.
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Alvotech Initiates Confirmatory Patient Study For AVT16, A Proposed Biosimilar To Entyvio®
9/25/2024
Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab).
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Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024
9/25/2024
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam.
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Bio-Sourcing Secures European Innovation Council (EIC) Accelerator Funding To Bridge The Biomanufacturing Gap And Make Biotherapeutics More Available And Affordable
9/24/2024
Bio-Sourcing, a pioneering Belgian biotherapeutic company, announces today the award of €2.5M in grants and €10M in equity from the European Innovation Council (EIC) Accelerator.