Two More Pairs of Denosumab Biosimilars Enter US Market

The Top 5 Biosimilar Articles for the Week of October 23

October 27th 2023

By Skylar Jeremias

Here are the top 5 biosimilar articles for the week of October 23, 2023.

AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry

October 26th 2023

By Skylar Jeremias

Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.

Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future

October 25th 2023

By Skylar Jeremias

As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.

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.