Biosimilars

After a biosimilar introduction, the prices of the biologic products—namely, trastuzumab, infliximab, bevacizumab, adalimumab, filgrastim, and pegfilgrastim—were significantly reduced.

Disease activity was similar between patients with JIA undergoing a non-medical biological switch and those continuing the originator anti-TNF product.

The Council recommends the elimination of unnecessary clinical efficacy trials and establishing global regulatory comparators.

The biosimilars month in review highlights recent FDA approvals and successful comparison trials.

At 1 year, patients with treated with IL-23 switched or swapped biological treatment less frequently compared with IL-12/23, IL-17, and TNF-α inhibitors.

Healthcare professionals who were aware of the safety and efficacy of biosimilars were more likely to prescribe or switch patients to a biosimilar.

A similar proportion of patients sustained baseline clinical status across treatment arms.

Statistically significant higher proportions of patients with CD or UC receiving subcutaneous CT-P13 achieved clinical remission compared with placebo.

At week 54, the clinical remission rate among patients receiving originator infliximab was 92.5% compared with 100% in the biosimilar CT-P13 group.

Both the high-concentration and reference formulations of biosimilar adalimumab-adbm exhibited comparable pharmacokinetics and immunogenicity, with a similar safety profile.

The FDA approved eculizumab-aeeb (Bkemv) as an interchangeable biosimilar to eculizumab (Soliris) for treating PNH and aHUS, marking the agency’s 53rd biosimilar approval.

On May 20, 2024, the FDA announced the approval of 2 products as interchangeable biosimilars to aflibercept—the first products to receive such a designation from the FDA.

Boehringer Ingelheim expands access to adalimumab biosimilar adalimumab-adbm through agreement with Quallent Pharmaceuticals,

Expert providers in inflammatory diseases provide additional resources on biosimilars and adalimumab biosimilar for patients and providers.

Providers in inflammatory diseases discuss the instrumental role nurses and support staff play in educating patients on adalimumab biosimilars.

Drs Lio, Botsoglou, and Alexrad discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Clinicians and a pharmacist discuss how they are managing access and assistance with copay assistance program in their practices.

Healthcare providers in inflammatory diseases talk about the role they have on encouraging adalimumab biosimilar use in clinical practice.

The biosimilars month in review reflects ongoing efforts to address key challenges in rheumatic disease treatment.

The current approval is based on the VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

Specialists in rheumatology, dermatology and gastrointestinal disease share their clinical experience on initiating or switching their patients on adalimumab biosimilars.

Specialists in rheumatology, dermatology and gastrointestinal disease discuss the evidence on efficacy and safety on switching patient to an adalimumab biosimilar.

Providers in rheumatology, dermatology and gastrointestinal disease talk about how they are selecting between the various adalimumab biosimilars available for their patients.

A clinical pharmacist and specialists in rheumatology, dermatology, and gastrointestinal disease share strategies in how to increase the uptake of adalimumab biosimilar among providers.

The FDA approved ustekinumab-aekn for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.