Rheumatology

Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.

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.

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.

In a recent comparability analysis, a proposed biosimilar to etanercept (that the developers hope to sell as Altebrel) underwent direct comparison to the reference and was found to have a high similarity in terms of glycosylation, primary structure, and in-vitro functionality.

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.

Drug maker Mycenax has reported positive phase 1 data for its proposed biosimilar tocilizumab, referencing Actemra.

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

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.

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).

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.

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.