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Top centerforbiosimilars.com News

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

United States · United States

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

71% Center coverage: 32 sources

Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kgThe FDA previously approved STEQEYMA® 45mg/0.5mL, 90mg/mL in a single-dose prefilled syringe for subcutaneous…See the Story

Biocon's Breakthrough: Yesafili Gets Green Light in Canada

Health Canada · Toronto

Biocon's Breakthrough: Yesafili Gets Green Light in Canada

67% Left coverage: 9 sources

Biocon Biologics has received Health Canada's approval for Yesafili, a biosimilar injection for eye ailments. As the first Eylea biosimilar approved in Canada, Yesafili's launch is set for July 4, 2025. This milestone highlights Biocon's commitment to affordable, high-quality biologics worldwide.See the Story

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.See the Story

Expanding Access to Generics and Biosimilars Could Help Reduce Rising Medication Costs

A recent opinion piece has highlighted the potential be […] The post Expanding Access to Generics and Biosimilars Could Help Reduce Rising Medication Costs first appeared on GeneOnline News. The post Expanding Access to Generics and Biosimilars Could Help Reduce Rising Medication Costs appeared first on GeneOnline News.Pharma · United States See the Story

Omalizumab Biosimilar Matches Reference Product in Chronic Spontaneous Urticaria

CT-P39, an omalizumab biosimilar, shows comparable efficacy and safety to the original in treating chronic spontaneous urticaria, enhancing patient access.Read Article

BioRationality: Questioning Experts and Journals Reporting on Biosimilar Bill to Remove Interchangeability

The debate over the Biosimilar Red Tape Elimination Act raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.United States · United States Read Article

Tocilizumab Biosimilar CT-P47 Shows Promise for Rheumatoid Arthritis Self-Administration

Tocilizumab biosimilar CT-P47, administered via autoinjector, offers comparable efficacy and a consistent safety profile to reference tocilizumab in patients with rheumatoid arthritis.Read Article

Strengthening Diabetes Care With Purpose-Built Data Infrastructure

Explore how real-world evidence and biosimilars enhance insulin access and adherence, improving diabetes care and outcomes for patients who have type 2 diabetes.Fredericton · Fredericton See the Story

Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.Germany · Germany Read Article

High Acceptance Levels After Switching to an Adalimumab Biosimilar for IBD

Patients with inflammatory bowel disease (IBD) show high acceptance of adalimumab biosimilars, achieving positive outcomes and clinical remission after switching.Read Article

Biosimilar FYB202 Confirms Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.Read Article

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