Gastroenterology

Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar

November 22nd 2023

By Skylar Jeremias

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

Study Confirms Safety and Efficacy of Adalimumab Biosimilar HS016 in IBD

November 21st 2023

By Cameron Santoro

Article

A China-based study where data were collected from patients with inflammatory bowel disease (IBD) showed safety and efficacy of the adalimumab biosimilar HS016.

Public Payer in Poland Saves €243 Million by Using Biosimilar TNF Inhibitors

November 11th 2023

By Skylar Jeremias

Article

The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.

Real-World Data Confirm Safety, Efficacy of CT-P13 in Inflammatory Diseases

November 9th 2023

By Skylar Jeremias

Article

A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.

Physicians Agree on Safety of Biosimilars, Nonmedical Switching in IBD, Survey Says

November 2nd 2023

By Skylar Jeremias

Article

An international survey found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.

FDA Approves First Stelara Biosimilar, Wezlana

November 1st 2023

By Skylar Jeremias

Article

The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation.

Biosimilars Business Roundup: October 2023

November 1st 2023

By Skylar Jeremias

Article

Between 3 regulatory approvals, 2 complete response letters, and new data and industry insights, October brought a number of business updates that have the potential to impact the entire US biosimilar industry.

Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and Bioparallels

October 30th 2023

By Ivo Abraham, PhD

Article

In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market

October 29th 2023

By Skylar Jeremias

Video

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.

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

October 25th 2023

By Skylar Jeremias

Article

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.