Rheumatology

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.

Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.

Current treatment for cutaneous lupus erythematosus (CLE) commonly focuses on photoprotection, topical therapies, corticosteroids, antimalarial drugs, and immunosuppressive drugs. More recently, B-cell depleting therapies, such as rituximab, have shown promise in treating systemic lupus erythematosus, though the feasibility of treating CLE with rituximab has not been well described.

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

As more biosimilars are earning regulatory approvals in both the United States and the European Union, the question of whether to switch patients (and at what point to do so) continues to be discussed; researchers will present findings from 2 etanercept switching studies in patients with rheumatoid arthritis (RA) during the American College of Rheumatology’s (ACR) Annual meeting, held in Chicago, Illinois October 19-24, 2018.

With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.

During the American College of Rheumatology’s Annual Meeting, held in Chicago, Illinois from October 19-24, 2018, various researchers will present findings on the safety, efficacy, and immunogenicity of 3 adalimumab biosimilars.

The potential for the development of antidrug antibodies is a key concern among prescribers who use all biologics that target tumor necrosis factor (TNF). Two presentations at the American College of Rheumatology Annual Meeting in Chicago, Illinois, which will be held from October 19-24, 2018, will address the immunogenicity of biosimilars in patients with rheumatoid arthritis and other inflammatory diseases.

As biosimilar etanercept SB4, sold in many markets as Benepali, has entered the rheumatoid arthritis treatment space, researchers have recognized the need to investigate the retention rates and disease activity scores among patients receiving SB4 and its reference.

Stakeholders hoping to see increased uptake of biosimilars in the United States are increasingly pointing to a lack of provider awareness as a key hindrance to the biosimilars marketplace. New research, to be presented at the American College of Rheumatology Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, suggests that, despite efforts to educate providers, awareness of biosimilars—as well as awareness of patients’ attitudes toward them—remains low.

One day after Sandoz and Amgen announced European launches of their biosimilar adalimumab products referencing Humira, Samsung Bioepis announced that it has launched its own biosimilar, Imraldi.

As more biosimilars are poised to become available to US patients, American rheumatologists are looking to their European counterparts for lessons learned from nonmedical switches from reference products to biosimilars. During the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, several research teams will present on nonmedical switching in the European context.

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom, and Amgen announced that it will begin making its Amgevita available in multiple European markets.

A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars.

During the American College of Rheumatology 2018 annual meeting, which will be held from October 19-24 in Chicago, Illinois, a variety of researchers will present on real-world data concerning biosimilar infliximab CT-P13.

The paper reports findings from a study that used retrospective data from a single center in Poland from 2009 to 2014. Records from a total of 104 patients, each of whom received infliximab, etanercept, or adalimumab under the National Health Fund, were assessed.

The National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.

The latest review seeking to reassure clinicians about the safety of switching their patients to biosimilars focuses on rheumatology indications.

Treating ankylosing spondylitis (AS) is costly, even in high-income nations. In lower-income countries, patients may face serious challenges in accessing high-cost drugs, like anti–tumor necrosis factor agents, even when biosimilars are available.

During the 20th Asia Pacific League of Associations for Rheumatology (APLAR) Congress, held September 6 to 9 in Kaohsiung, Taiwan, researchers presented on real-world experience with switching to biosimilars in treating rheumatic diseases.

Adherence and persistence rates for biologic drugs are still low in the United States, leading to suboptimal patient outcomes and putting a substantial burden on the healthcare system.

Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.

Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.

Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.

Because patients with rheumatoid arthritis may have compromised manual dexterity, they may have challenges with self-administering their biologic therapies. In the case of etanercept, which is typically administered once per week, device design that prioritizes ease of use can help improve patient adherence to treatment regimens.

The advent of biosimilar etanercept, Benepali, in the United Kingdom has provided a significant opportunity for cost savings, given the biosimilar’s lower price than the reference Enbrel. As such, hospitals have been undertaking nonmedical switches to the biosimilar in order to benefit from these savings. During the British Society for Rheumatology 2018 Annual Conference, held in May in Liverpool, United Kingdom, investigators reported on the results of these switches, both on the financial wellbeing of the health system and on patients.