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FDA Approves Amgen and Allergan’s Kanjinti, a Biosimilar to Herceptin

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is …

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Statement from Acting FDA Commissioner Sharpless on Policy Advancements to Bring Interchangeable Biosimilars to Market

The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics. Today, the FDA is …

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Sandoz Enters Agreement with EirGenix for Proposed Trastuzumab Biosimilar in Phase 3 Development

Holzkirchen, Germany, April 30, 2018 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar. This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) …

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FDA Approves Samsung Bioepis’ Eticovo, a Biosimilar to Enbrel

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second …

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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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