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Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease

LONDON–(BUSINESS WIRE)–Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1 CT-P13 is …

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Samsung Bioepis Announces Three-year Follow-up Data for Biosimilar Ontruzant in Early or Locally Advanced HER2-Positive Breast Cancer

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced findings of a three-year follow-up study comparing biosimilar ONTRUZANT® (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer. The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer …

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FDA Approves Pfizer’s Trazimera, a Biosimilar to Herceptin

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an important …

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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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