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Biosimilars

Coherus Reaches Settlement with AbbVie, Securing Rights to Commercialize its Adalimumab Biosimilar Candidate, CHS-1420

REDWOOD CITY, Calif., Jan. 25, 2019 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, today announced it has executed settlement agreements with AbbVie Inc. that grant Coherus global, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab (HUMIRA®) biosimilar.  The global settlements …

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Amgen and Allergan Announce Positive Top-Line Results from Phase 1/Phase 3 Study of ABP 798, Biosimilar Candidate to Rituximab

THOUSAND OAKS, Calif., Jan. 24, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc.(NYSE:AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. The results demonstrate that the study …

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FDA Approves Ontruzant, Samsung Bioepis’ Herceptin Biosimilar

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® 1 (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have …

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Amgen Submits BLA to the FDA for ABP 710, a Biosimilar Candidate to Infliximab

THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …

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Celltrion and Teva Announce FDA Approval of Herzuma, a Biosimilar to Herceptin, for Treatment of HER2-Overexpressing Breast Cancer

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 HERZUMA® (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to HERCEPTIN®1 (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR …

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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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