Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

Transitioning to Biosimilars: Considerations for Providers and Payers

October 24th 2023

Panelists explore opportunities for biosimilars to manage inflammatory conditions.

Utilizing Recently Approved Biosimilars in Clinical Practice

October 24th 2023

Experts explore current and future use of biosimilars in dermatology, gastroenterology, and rheumatology.

Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake

October 24th 2023

By Skylar Jeremias

Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.

FDA Approves First Subcutaneous Infliximab Product

October 23rd 2023

By Skylar Jeremias

The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.

Dr Stephen Hanauer Weighs In on Pharmacovigilence, Nonmedical Switching in Crohn Disease

October 22nd 2023

By Skylar Jeremias

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, discusses why providers need to be wary when deciding whether patients with Crohn disease should switch from Humira (reference adalimumab) to an adalimumab biosimilar.

BLA Resubmitted to FDA for On-Body Injector Presentation of Pegfilgrastim-cbqv

October 21st 2023

By Kristi Rosa

The biologics license application (BLA) seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of Neulasta Onpro, has been resubmitted to the FDA for review.

The Top 5 Biosimilar Articles for the Week of October 16

October 20th 2023

By Skylar Jeremias

Here are the top 5 biosimilar articles for the week of October 16, 2023.

Eye on Pharma: Another CRL for Alvotech; Cimerli’s Growing Market Share; BBCIC Awarded Grant

October 19th 2023

By Skylar Jeremias

Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).

Navigating Data Integrity for Generic Drug Approvals

October 18th 2023

By Ayaaz Hussain Khan, PhD

Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data.

Review: Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim in Clinical Studies

October 17th 2023

By Deana Ferreri, PhD

Researchers of a literature review found similar safety profiles between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.