Biosimilar Development News
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Samsung Bioepis Secures US License Date For SB17, A Proposed Biosimilar To Stelara®
11/30/2023
Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between the two companies and clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara® (ustekinumab) in the United States (US). In the US, the license period will begin on February 22, 2025.
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Biocon Biologics Successfully Completes Integration Of Viatris' Biosimilar Business In 31 Countries In Europe
11/30/2023
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris' biosimilars business in 31 European countries has been successfully completed.
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Alvotech Announces Positive Top-Line Results From A Pharmacokinetic Study For AVT05, A Proposed Biosimilar For Simponi® And Simponi Aria®
11/29/2023
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
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Bio-Thera Solutions Announces Positive Results From Phase 3 Study Of BAT2206, A Proposed Biosimilar Referencing Stelara®
11/29/2023
Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara® (ustekinumab).
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Formycon Announces EMA Submission For FYB203, A Biosimilar Candidate To Eylea (Aflibercept)
11/27/2023
Formycon AG and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA).
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EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization By EC
11/22/2023
EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC).
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Sandoz launches Hyrimoz® (adalimumab) High-Concentration Formulation In Europe, Aiming To Improve Patient Care
11/21/2023
Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Hyrimoz® (adalimumab) citrate-free high concentration formulation (HCF; 100 mg/mL) in Europe. The medicine will become available to patients progressively across European markets, starting today.
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Report: Hundreds Of Thousands Of Patients Across Europe Miss Out On Advanced Medicines Due To Low Biosimilar Adoption
11/16/2023
Founded and sponsored by Sandoz, the Act4Biosimilars initiative launches the Deep Dive Report for Europe, exposing the challenges preventing greater patient access to biosimilars in this region.
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Affordable Prescription Drugs Exist — Why Can’t More Patients Access Them?
11/16/2023
The United States is a global leader in medical innovation. Unfortunately, due to perverse incentives that exist in our current health care system to block lower-cost drugs from the marketplace, patients have difficulty accessing and affording those life-saving treatments.
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Alvotech And JAMP Pharma Announce Receipt Of Marketing Authorization For Jamteki (AVT04), The First Biosimilar Of Stelara® (ustekinumab)
11/14/2023
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech.