Gastroenterology

Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar

February 22nd 2025

By Deana Ferreri, PhD

Article

A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.

Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Remicade in IBD

February 15th 2025

By Deana Ferreri, PhD

Article

Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.

Welcome Wezlana: Using Adalimumab to Predict Ustekinumab Market Potential

February 10th 2025

By Dracey Poore

Article

2025 marks a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer

February 8th 2025

By Deana Ferreri, PhD

Article

A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.

The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars

February 5th 2025

By Skylar Jeremias

Article

Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

January 31st 2025

By Skylar Jeremias

Article

January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

Eye on Pharma: Teva, Formycon, Celltrion Biosimilar Updates in Global Markets

January 26th 2025

By Skylar Jeremias

Article

Three players in the biosimilar space have already sparked hope for the new year, with each having big business or regulatory announcements regarding new biosimilar products in Europe and Canada.

No Disease Activity Changes After Children With IBD Switched to Infliximab Biosimilar

January 25th 2025

By Deana Ferreri, PhD

Article

A real-world study in adolescent and young adult patients with inflammatory bowel disease (IBD) found no significant differences in lab markers or disease activity between those on Remicade and those switched to biosimilar CT-P13 (Inflectra).

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

January 21st 2025

By Skylar Jeremias

Article

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease

January 18th 2025

By Deana Ferreri, PhD

Article

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.