FDA Milestone: 75th Biosimilar Medication Is Approved!
U.S. Food and Drug Administration (FDA) shared on LinkedIn:
”Exciting Announcement!
The FDA has reached another milestone with the approval of its 75th biosimilar medication!
This achievement represents a major step forward in ensuring more patients have access to critical, life-saving treatments without compromising on quality or safety.
Learn more about biosimilars”
According to the FDA, a biosimilar is a biological product that closely resembles an already FDA-approved reference product and shows no clinically significant differences in safety or effectiveness.
Biosimilars are approved for use across a wide range of diseases, from Crohn’s disease to HER2-positive breast cancer.
For example, Zarxio can serve as an alternative to Neupogen (filgrastim), while the newly approved Avsola is intended to replace Remicade (infliximab) for various autoimmune conditions.
One key advantage of these drugs is that they maintain high standards of safety, efficacy, and quality, while also providing more cost-effective treatment options.
Thus, biosimilar products approved by FDA must also meet requirements mentioned in Biologics Price Competition and Innovation Act.
More on the latest FDA Approvals featured in Hemostasis Today.
-
Oct 3, 2025, 07:53Pancytopenia in Pregnancy: A Time-Critical Hematological Emergency
-
Oct 2, 2025, 14:12Helen McPherson at ISFP-IFRS 2025: Fibrin Clot Structure and Function Modulation by Targeting Fibrinogen aC Region
-
Oct 2, 2025, 10:48Kanishk Kumar: TFPI Market Size - Advancing Hemostasis and Antithrombotic Therapy
-
Oct 2, 2025, 07:31Non-Invasive Management of Radial Artery Pseudoaneurysm
-
Oct 2, 2025, 07:28Mohamed Gamal: Rethinking The Standard of Care for Deep Vein Thrombosis Management
-
Oct 3, 2025, 14:00Quentin Van Thillo Shares His Latest Article on VWD: Grateful to Have Worked with Cedric Hermans
-
Oct 3, 2025, 13:40Cihan Ay and Colleagues on Thromboembolism and Bleeding in Multiple Myeloma
-
Oct 3, 2025, 13:27Laura Haynes: This Was Such a Fun and Collaborative Project to Be a Part of!
-
Oct 3, 2025, 12:40Christian Pfrepper and Team's Letter on Emicizumab Plasma Concentration Measurment in EDTA plasma
-
Oct 3, 2025, 12:00Giuseppe Lippi and Colleagues on the Impact of Hemolysis on Coagulation Testing
-
Oct 3, 2025, 15:31Anirban Sen Gupta and Andrew Shoffstall Collaboration on Bioinspired Synthetic Platelet Systems for Brain Injury Treatment
-
Oct 3, 2025, 15:07Shai Shen-Orr: Excited to Share that The Human Immunome Project (HIP) Has Launched Its Scientific Partner Network
-
Oct 2, 2025, 04:59Caterina Casari - Prizes for Innovators 2025 Winner!
-
Oct 2, 2025, 04:572025 Innovators Award: Ile de France Région Recognizes 3 Researchers Who Have Committed Themselves to The Innovation
-
Oct 1, 2025, 15:59Anirban Sen Gupta: Thrilled to share a great collaboration story in Nature Portfolio
-
Oct 3, 2025, 14:48Maha Othman - Elected as the Co-Lead for the Basic and Translational Research Platform at CanVECTOR Research Network
-
Oct 3, 2025, 14:41Maria Elisa Mancuso: A Real Pleasure to Participate in The Policy Roundtable on Future of Haemophilia Care in Egypt
-
Oct 2, 2025, 04:37Louise Bannon: Did You Know that 1 in 4 People Lose Their Lives to Blood Clot-Related Conditions?
-
Oct 1, 2025, 16:35World Thrombosis Day 2025․ 8 Ways to Take Control and Save Lives
-
Oct 1, 2025, 12:30World Stroke Academy "Antithrombotic Therapy for Atherosclerotic Stroke Prevention" Webinar is Now Available to Record