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Biosimilars

Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today at the American Society of Hematology Annual Meeting that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan®/MabThera® (rituximab-EU)i, met its primary endpoint of overall response rate (ORR) at Week 26 of the 52-week study.1 “It is encouraging to …

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FDA Approves Celltrion’s Truxima, a Biosimilar to Rituxan, for Treatment of Adult Patients with Non-Hodgkin’s Lymphoma

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA® (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN®1 (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, …

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Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems

LONDON–(BUSINESS WIRE)–Celltrion Healthcare outlined their vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, US. Biosimilars offer healthcare providers and patients greater treatment choice and value, better access to treatments and improved patient outcomes. According to data provided by IMS …

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FDA Approves Coherus’ Udenyca, a Biosimilar to Neulasta

REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved UDENYCA™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy.  UDENYCA™ …

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FDA Approves Sandoz’s Biosimilar Hyrimoz (adalimumab-adaz) for all Indications of Reference Medicine

Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years …

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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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