Bone Health

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data

November 19th 2024

By Skylar Jeremias

Article

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.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

November 5th 2024

By Skylar Jeremias

Article

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.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

October 15th 2024

By Skylar Jeremias

Article

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.

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

August 21st 2024

By Skylar Jeremias

Article

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.

Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data

July 10th 2024

By Skylar Jeremias

Article

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.

Eye on Pharma: New Data, Clinical Developments, and Biosimilar Partnerships

July 4th 2024

By Skylar Jeremias

Article

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.

FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

June 20th 2024

By Skylar Jeremias

Article

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.

Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved

June 16th 2024

By Skylar Jeremias

Podcast

In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.

Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships

June 6th 2024

By Skylar Jeremias

Article

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

ASCO 2024 Posters Showcase Positive Data on Denosumab, Pegfilgrastim Biosimilars

June 5th 2024

By Skylar Jeremias

Article

Posters from the American Society of Clinical Oncology (ASCO) 2024 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.