Practice

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.

A recent systematic review of the literature reported on randomized controlled trials and nonrandomized studies on the use of granulocyte colony-stimulating factor therapies (G-CSFs) to reduce the incidence of febrile neutropenia, and found that short- and long-acting therapies, when dosed according to guidelines, have little difference in their efficacy.

A recent study sought to investigate the overall survival (OS) advantage of the addition of trastuzumab to chemotherapy for patients with human epidermal growth factor 2-positive early breast cancer.

The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.

The launch of biosimilar rituximab is an eagerly awaited event among US healthcare stakeholders who are cognizant of the high cost of intravenously (IV) administered rituximab in treating non-Hodgkin lymphoma (NHL). At the same time, another innovation in rituximab delivery—a subcutaneously administered rituximab formulation—has the potential to save both cost and time.

For health systems like the Veterans Health Administration (VHA), where controlling costs while providing high-quality care is of heightened concern, achieving the best value for money in the prophylaxis of neutropenia can help to control the cost of cancer care.

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).

Celltrion’s CT-P10, a biosimilar rituximab that was FDA approved under the brand name Truxima in November 2018, is already in wide use for a host of indications in many regulatory territories. During this week’s 60th Annual Meeting and Exposition of the American Society of Hematology in San Diego, California, multiple research teams are reporting data that underscore the safety and efficacy of CT-P10 in hematological conditions.

In 2016, the Saskatchewan Cancer Agency switched from the brand-name filgrastim, Neupogen, to a biosimilar, Apotex’s Grastofil, for stem cell mobilization prior to autologous stem cell transplants. In a study presented at the American Society of Hematology’s Annual Meeting, researchers sought to determine the safety and efficacy of using a biosimilar for this setting.