Biosimilars

Boehringer Ingelheim’s Biosimilar Candidate Demonstrates Bioequivalence to Avastin

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim today announced new data from the Phase I INVICTAN®-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and –EU approved Avastin®. *Avastin® is an angiogenesis inhibitor that is used to treat a variety of cancers. BI 695502 met all the …

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Amgen and Allergan Submit BLA for Biosimilar Candidate to Avastin

THOUSAND OAKS, Calif., Nov. 15, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 215, a biosimilar candidate to Avastin® (bevacizumab). ABP 215 is the most advanced of the four …

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Celltrion Presents New Data Supporting Efficacy and Safety of its Biosimilars

WASHINGTON–(BUSINESS WIRE)–New data presented today at the 2016 American College of Rheumatology (ACR) Annual Meeting demonstrate that the efficacy and safety profile of CT-P10 (biosimilar rituximab) in rheumatoid arthritis (RA) patients is comparable to patients treated with originator rituximab over 24 weeks.1,2 A total of 372 RA patients (161 patients …

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Eagle Pharma Enters Biosimilar Market through its Acquisition of Arsia Therapeutics

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals (“Eagle” or the “Company”) (NASDAQ:EGRX) today announced that it has signed a definitive agreement to acquire Arsia Therapeutics (“Arsia”), an early-stage biotechnology firm with proprietary viscosity-reducing technology and formulation know-how. The acquisition will mark Eagle’s entry into biologics, the fastest growing sector of the pharmaceuticals …

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Mylan Seeks FDA Approval for Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Nov. 8, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This …

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Boehringer Ingelheim’s Biosimilar Candidate Shows Similar Efficacy and Safety Profile to Humira in Phase 3 Study

Ingelheim, Germany, 26 October, 2016 – Boehringer Ingelheim today announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira® and EU approved Humira® (adalimumab)*. BI 695501 met the clinical study primary efficacy endpoint to establish equivalence with Humira® in patients with …

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Pfizer Announces the US Availability of Biosimilar Inflectra

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the company will begin shipment of INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE®1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be …

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Teva and Celltrion Announce Exclusive Biosimilar Commercial Partnership

JERUSALEM and INCHEON, South Korea–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA), Celltrion, Inc. and Celltrion Healthcare today announce that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada. CT-P10 is a proposed mAb biosimilar to Rituxan® (rituximab), …

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FDA Approves Amgen’s Humira Biosimilar for Treatment of Seven Inflammatory Diseases

THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment …

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Pfizer’s Remicade Biosimilar Candidate Succeeds in Late-Stage Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology …

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