December 11th 2024
By Skylar Jeremias
Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.
December 10th 2024
Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
November 26th 2024
By Ashling Wahner
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.
November 19th 2024
The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
November 5th 2024
Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
October 15th 2024
Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
August 21st 2024
Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
July 10th 2024
The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.
July 4th 2024
As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.
June 20th 2024
The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
