Deana Ferreri, PhD

Researchers reviewed real-world evidence on the safety and effectiveness of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces.

A real-world study of the use of adalimumab biosimilars in pediatric inflammatory bowel disease (IBD) in Sicily found “high rates” of clinical remission and treatment persistence, and no unexpected safety concerns.

A real-world study in Spain on patients with inflammatory bowel disease (IBD) found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.

In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.

A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.

A review article summarized the totality of evidence supporting the approval of the adalimumab biosimilar GP2017 (Hyrimoz; Sandoz) in the United States and Europe.

In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.

A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.

A systematic review and meta-analysis of 7 randomized controlled trials found no significant differences in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.

A review article described the totality of evidence supporting the approval of the adalimumab biosimilar AVT02 (Simlandi; Alvotech) for all approved indications of the reference product, Humira.

A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.

A recent study used difference-in-difference analysis to assess adalimumab sales volumes and expenditures in 6 countries with and 8 countries without available biosimilar adalimumab products.

The adalimumab biosimilar SB5 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.

A retrospective study analyzing 3 years of treatment patterns for patients with Crohn disease on biologics found that while more patients received infliximab, adalimumab, and vedolizumab initially, ustekinumab showed the highest persistence and lowest dose escalation rate, indicating potentially better clinical response compared to other biologics.

Cyltezo (adalimumab-adbm) was the first adalimumab biosimilar—and second biosimilar overall—to receive an interchangeability designation from the FDA.

The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.

The PERFUSE study in France on biosimilar adalimumab SB5 for inflammatory bowel disease reveals high satisfaction overall, but significant variations in training and survey response rates across sites suggest a potential lack of support during treatment switches.

Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

The proposed bevacizumab biosimilar BAT1706 (Bio-Thera Solutions) demonstrated equivalence to the reference product (Avastin) in a phase 3 comparative efficacy trial in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

The biosimilar Enoxa (enoxaparin), marketed in Tunisia, demonstrated equivalence in preventing subclinical postoperative thrombotic events in patients with digestive cancers to Sanofi’s Lovenox, in a randomized controlled trial.

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

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.

A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.

A retrospective study of New England patients receiving trastuzumab or bevacizumab found that combining dose rounding and biosimilar use resulted in greater cost savings than either strategy alone.

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

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.

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.

Authors of a study examined changes in pricing, market share, and utilization of the tumor necrosis factor (TNF)–α inhibitors infliximab, etanercept, and adalimumab as the first and second biosimilars for each molecule were introduced in Europe.

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.