Top 5 Most-Read Rheumatology Articles of 2024

The top 5 rheumatology biosimilar articles of 2024 focus on key developments in biosimilar approvals and treatment options. These include the FDA's approval of innovative formulations, such as a high-concentration adalimumab biosimilar and a tocilizumab biosimilar, which expand access to treatments for autoimmune diseases, as well as new evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.

Here are the top 5 rheumatology biosimilar articles in 2024.

5. FDA Approves High-Concentration Cyltezo

The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim's Cyltezo (adalimumab-adbm), adding to its existing low-concentration, citrate-free formulation. This marks the fifth high-concentration Humira (adalimumab) biosimilar in the US market, further expanding treatment options for chronic inflammatory conditions like rheumatoid arthritis and Crohn disease. The new formulation, priced at a significant discount compared with Humira, aims to enhance accessibility for patients and advance the adoption of biosimilars in the health care system.

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4. Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment

A review article highlighted the importance of product attributes like citrate-free formulations, injection volume, needle gauge, and device preferences in adalimumab products, as these factors can significantly impact patients' experiences, treatment adherence, and outcomes. Health care professionals are encouraged to consider these features, along with interchangeability and patient support programs, when discussing adalimumab options with patients. Notably, citrate-free and low-volume formulations, thinner needles, and user-friendly devices can reduce injection-site pain and improve overall patient satisfaction.

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3. New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

A literature review of biosimilar-to-biosimilar switching, based on European data, confirmed the safety and efficacy of switching between biosimilars, especially for drugs like infliximab and adalimumab. New studies, including observational data from over 6000 patients, showed that switching maintained stable clinical outcomes, with few discontinuations or adverse events. Despite some skepticism, particularly in gastroenterology and ophthalmology, the evidence supports that biosimilar switching is effective and well-tolerated, although limitations such as small sample sizes and observational data exist.

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2. FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

The FDA approved Samsung Bioepis' Pyzchiva (ustekinumab-ttwe) as a biosimilar to Stelara (reference ustekinumab) for treating inflammatory conditions such as plaque psoriasis and ulcerative colitis, marking it as the third ustekinumab biosimilar approved in the US. Pyzchiva, which has an interchangeability designation, will be offered with both intravenous and subcutaneous administration options and is expected to increase access to biologic treatments while potentially reducing health care costs. The approval was supported by robust clinical data, demonstrating similar efficacy and safety to the reference product.

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1. FDA Green Lights Second Tocilizumab Biosimilar

The FDA has approved Fresenius Kabi's Tyenne (tocilizumab-aazg), the second tocilizumab biosimilar, and the first with both intravenous and subcutaneous administration options. Tyenne, which is approved for 4 indications, including rheumatoid arthritis and giant cell arteritis, is already available in over 10 countries and will be launched in the US following a patent settlement with Genentech. This approval marked a significant step in expanding affordable autoimmune treatments.

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