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Celltrion and Teva Announce FDA Advisory Committee Recommends Approval of CT-P10, a Proposed Rituximab Biosimilar

SILVER SPRING, Md. & JERUSALEM–(BUSINESS WIRE)– Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan®1 (rituximab) for the treatment of …

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Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the FDA

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018. …

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Biosimilar Cyltezo Demonstrates Clinical Equivalence to Humira in Patients with Moderate-to-Severe Plaque Psoriasis

RIDGEFIELD, Conn., Sept. 12, 2018 /PRNewswire/ — Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo® is equivalent to Humira®*, with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association …

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Celltrion Announces FDA Oncologic Drugs Advisory Committee Meeting Schedule for Proposed Biosimilar to Rituxan

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) today announced that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018. Rituxan® is a Biogen and …

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Celltrion Initiates Global Phase 3 Trial for its Bevacizumab Biosimilar CT-P16

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application …

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FDA Approves Pfizer’s Nivestym, a Biosimilar to Neupogen (filgrastim)

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. “The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options …

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Biogen Expands Biosimilars Business by Exercising its Option to Increase Ownership in Samsung Bioepis

CAMBRIDGE, Mass., June 28, 2018 (GLOBE NEWSWIRE) — Biogen (Nasdaq:BIIB) announced today it has exercised its option to purchase additional shares of Samsung Bioepis Co., Ltd., a joint venture established in 2012 by Samsung BioLogics Co., Ltd and Biogen. Under the terms of the 2012 joint venture agreement, Biogen will pay Samsung …

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Phase 3 Data of Amgen’s Infliximab Biosimilar Candidate Confirm Non-Inferiority

THOUSAND OAKS, Calif., June 27, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE®(infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary …

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Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last …

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Sandoz Presents New Long-Term and Switching Data for Biosimilars Zessly and Erelzi in Rheumatoid Arthritis

Holzkirchen, June 15, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly®(infliximab)[4],[5] and biosimilar Erelzi® (etanercept).[6],[7] Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi …

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