Practice

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

A recently published editorial linked to a previous switching study for patients who had been receiving reference infliximab (Remicade) to biosimilar infliximab (Inflectra) argues that the positive results of the trial “apparently settles the case in favor of unrestricted switching of 'expensive' originator to 'cheap' biosimilar infliximab. Yet, the devil is the details."

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 19, 2018.

A study published in Alimentary Pharmacology Therapeutics in December 2017 compared the outcomes, pharmacokinetics, and immunogenicity of treatment intensification strategies in patients with Crohn disease (CD) who have lost clinical response to the anti–tumor necrosis factor (anti-TNF) therapy infliximab.

In an animal model of bleomycin-induced lung toxicity, filgrastim increased alveolar neutrophil recruitment, pulmonary edema, and lung myeloperoxidase activity. That finding led to concerns about whether filgrastim could increase pulmonary toxicity when used together with adriamycin, bleomycin, vinblastine, and dacarbazine regimens.

Patients with rheumatoid arthritis (RA) who use corticosteroids can delay the initiation of biologic disease-modifying antirheumatic drugs (DMARDs), have higher incidence of adverse events (AEs), and have more healthcare costs before the initiation of biologic DMARDs than patients who do not use corticosteroids.

Last week, at the European Crohn's and Colitis Organisation's 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension of the NOR-SWITCH trial—concerning the inflammatory bowel disease (IBD) subgroup.

At the recent European Crohn's and Colitis Organisation’s 13th Congress in Vienna, Austria, several studies investigated the efficacy of infliximab biosimilars in treating Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA).

While corticosteroids are a common treatment for uveitis, effective corticosteroid-sparing therapies are necessary to maintain disease control without risking corticosteroid-related adverse events.

At the European Crohn’s and Colitis Organisation’s 13th annual congress, held in Vienna, Austria, a number of studies explored switching from reference infliximab to its biosimilar.

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti–Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS).

This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.

The TITRATE study is designed to investigate whether intensive management of RA leads to a greater number of remissions at 12 months, in addition to examining levels of disability, quality of life and acceptability, and cost-effectiveness.

According to Roy Fleischmann, MD, a recent American College of Rheumatology (ACR) white paper appropriately describes issues including the nomenclature of biosimilars, the biosimilar approval pathway, and differences between biosimilars for biologic drugs and generics for small-molecule drugs. However, he takes issue with ACR's stance on substitution, extrapolation, and interchangeability.

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

Researchers found that the biosimilar offered only limited efficacy when used for induction of remission in patients with moderate to severe ulcerative colitis that was refractory to treatment with steroids.

Some case reports have suggested that rituximab can effectively treat nephrotic syndrome, and a recent study sought to assess the safety and effectiveness of rituximab in treating patients who have steroid- and cyclosporine-resistant pediatric nephrotic syndrome.

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that affects approximately half of patients with psoriasis.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 5, 2018.

In late 2017, a study was published in Acta Reumatologica Portuguesa evaluating the effect adalimumab (Humira), an anti–tumor necrosis factor therapy in the treatment of patients with both short- and long-term psoriatic arthritis (PsA) disease duration.

The American College of Rheumatology (ACR)'s previous position on biosimilars was one of caution during the initial development, evaluation, and approval of these drugs, but, writes the organization, “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the [United States] is on the verge of a similar transition, the ACR is poised to reconsider its position.”

Managed care professionals can assist ophthalmologists and retina specialists in personalizing anti-vascular endothelial growth factor (anti-VEGF) treatment to encourage patient adherence, according to a recent review of the literature on this topic.

Because serum tumor necrosis factor (TNF) is high in patients with Kawasaki disease (KD), infliximab, an anti-TNF agent, has been proposed as a potential treatment for refractory KD, but few randomized trials have been conducted to demonstrate the efficacy and safety of using infliximab in this setting.

A cross-sectional study published in the International Journal of Clinical Pharmacy in late 2017 found that the uptake of biosimilars in the United Kingdom has been highly variable and generally lower than expected.

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

During the American College of Rheumatology's (ACR) Winter Rheumatology Symposium last week in Snowmass, Colorado, one of the sessions comprised a panel addressing treatment options for inflammatory arthritis. One case study the panel addressed the pros and cons of dose reduction versus an increase in dosing interval of a biologic for a patient with rheumatoid arthritis (RA) who has achieved low disease activity or remission.

A recent study, set in the Netherlands, sought to assess patients’ attitudes about redistributing unused, subcutaneously administered biologic drugs, which could allow potential cost savings for the health system. However, the study unexpectedly found alarming storage inconsistencies and patient nonadherence to storage guidelines for these drugs.