Gastroenterology

The FDA agreed to review an application for Hadlima (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for a Senate Finance Committee’s draft legislation promoting biosimilars.

A review article discussed the characteristics of the available adalimumab biosimilars to help clinicians navigate the various treatment options with their patients.

Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.

Patients with inflammatory bowel disease (IBD) receive additional evidence on the safety and efficacy of adalimumab biosimilar GP2017 treatment.

A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.

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).

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

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.

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.

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.

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.

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.

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.

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.

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.

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

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

Patients with inflammatory bowel disease who underwent a switch from reference infliximab to a biosimilar and then back to the originator were more likely to discontinue their treatment than patients who underwent a single switch from the originator to a biosimilar.

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

CVS Health Corporation launched Cordavis, a new subsidiary that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.

Switching from reference to biosimilar adalimumab was found to be safe and effective. Researchers cautioned that female patients may be at higher risk of discontinuation compared with their male counterparts.

A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab biosimilars were clinically equivalent to their reference products.

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, published her opinions on the future of biosimilars in the United States, foreshadowing immense growth and a transformation of the US health care industry thanks to biosimilars.

A study on the stability of the adalimumab biosimilar candidate TUR01, a tumor necrosis factor-α inhibitor, found long-term stability of the drug substance and drug product were maintained under different temperatures.

Samsung Bioepis and Organon released results from an interchangeability study of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.

The list price of Humira (reference adalimumab) has risen so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

A review article sheds light on the growing adalimumab market in the US, including how these products are being priced, strategies companies are using to make their product stand out, and recommendations for policymakers to ensure the accessibility and affordability of these products.