Practice

While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).

Acute severe ulcerative colitis (ASUC) can occur in up to 25% of patients with UC. Salvage therapy with infliximab or cyclosporine is standard first-line therapy for patients who do not respond adequately to intravenous corticosteroids, but questions have arisen about the cost-effectiveness of this approach versus early colectomy. A recent study, conducted in a tertiary hospital network in Australia, sought to compare healthcare utilization and costs between patients with ASUC who had early colectomy and those who were treated with infliximab.

GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.

New research, published in BioDrugs, underscores the long-term efficacy and safety of treating rheumatoid arthritis (RA) with biosimilar rituximab, CT-P10.

In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.

While the body of reassuring data on the safety and efficacy of biosimilars continues to grow, worrisome information about stakeholders’ levels of awareness of these products is also coming to light, and January 2019 saw the publication of a spate of studies showing low levels of patient and provider education on biosimilars.

While a majority of survey respondents said that they were at least somewhat familiar with current developments in oncology biosimilars, analyses of open-ended definitions found that only 1 participant could fully define a biosimilar, according to researchers.

Biosimilar adalimumab is making its way to patients, some of whom have expressed concerns about the presence of citrate in some of the available biosimilars.

In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation have been observed when these studies are compared with blinded switching studies.

Despite the fact that biosimilars have a longer history in the European Union than in the United States, many European patients still lack awareness of these medicines, and data suggest that a lack of awareness may be keeping patients from adhering to their therapies.

The study investigators noted that the number of individual case safety reports related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy.

In 2018, Green Shield Canada launched its pilot Biosimilar Transition Program, through 3 plan sponsors, under which patients already receiving biologics were switched to biosimilars. Now that the pilot is complete, the payer is calling the program a success.

The package leaflet provided to a patient with any drug product includes crucial information about a given therapy that can increase adherence and appropriate use of the product. To help make these leaflets as useful as possible for patients, in 2009, the European Commission published a new guideline on the readability of these labels with the aim of making them easier for patients to understand.

A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.

Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis. Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.

The body of evidence demonstrating the safety and efficacy of biosimilar infliximab, CT-P13 (Inflectra, Remsima), is growing, particularly in the extrapolated indication of inflammatory bowel disease (IBD). This month saw the publication of 2 new studies that provided reassuring data on CT-P13, one of which focused on switching pediatric patients with IBD to CT-P13, and the second of which explored switching to the reference infliximab from the biosimilar in adults with IBD.

This week, investigators published the results of the MAPLE study, a phase 3 trial of Amgen’s bevacizumab in comparison with the reference, Avastin, in patients with advance nonsquamous non–small cell lung cancer who were also receiving first-line chemotherapy with carboplatin and paclitaxel.

While 63% of respondents who had switched to a biosimilar said that they had been consulted in some form prior to the transition, 37% said that they had not been consulted (despite the fact that National Health Service guidelines require the patient to be consulted about such a switch).

The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.

Biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice. A newly published systematic review evaluated US and European healthcare provider knowledge, perceptions, and prescribing behaviors related to biosimilars, and it found that providers are still taking a cautious approach to biosimilars in part because of a lack of awareness of these medicines.

In children, idiopathic nephrotic syndrome (NS) generally responds well to treatment with corticosteroids, but long-term use of steroids in children can produce adverse effects (AEs) such as growth impairment and hypertension. Calcineurin inhibitors, too, are associated with AEs, including toxicity and diabetes. Rituximab has been proposed as an option for difficult-to-treat childhood-onset NS, and a recent study evaluated the efficacy and safety of a single dose of rituximab in this setting.

Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.

Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.

Vedolizumab is approved by the FDA for the treatment of moderate to severe Crohn disease or ulcerative colitis, both forms of inflammatory bowel disease (IBD), who have had an inadequate response or loss of response to immunomodulators, tumor necrosis factor inhibitors, or corticosteroid therapy.

On the heels of the FDA approval of Celltrion’s rituximab biosimilar Truxima in November 2018, December saw the publication of a variety of new data on biosimilars used in hematology.

Germ cell tumors are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia related to myelosuppression has not been well investigated in patients with this tumor type.

While Kawasaki disease (KD) typically affects children, it can, in rare cases, affect adults, leading to coronary artery abnormalities and acquired heart disease. Given that the disease is rare in adults and that its etiology is not fully understood, diagnosis and treatment of KD in adults can be challenging.

A recent study evaluated the impact of adding bevacizumab to chemotherapy treatment for patients who were newly diagnosed with ovarian cancer. The results, published in Gynecologic Oncology, found that while the addition of bevacizumab greatly improved progression-free survival (PFS), it did not improve overall survival.