Rheumatology

The study aimed to provide insight into the real-world patterns of biosimilar initiation in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in Korea by identifying patient characteristics and other factors associated with starting biosimilars using a logistic regression model.

Updated guidelines from the European League Against Rheumatism (EULAR), based on new evidence and a review of the literature from 2016 to 2018, address recommendations on the use of disease-modifying antirheumatic drugs and glucocorticoids to treat patients with rheumatoid arthritis (RA). Included is guidance on mono- and combination therapies, treatment strategies, and tapering treatment.

Health New England says it achieved 93% utilization by requiring prior authorization.

The company's announcement of an aggressive launch calendar at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.

It is the first adalimumab biosimilar approved by the China National Medical Products Administration.

The study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.

Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.

The Innovation and Value Initiative (IVI) has updated its existing prototype economic model examining value among rheumatoid arthritis (RA) therapies to include biosimilars.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.

Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic, discusses whether biosimilars are generating cost savings for patients with inflammatory diseases.

Using the same dosing as treatment for lymphoma and older age were linked with higher odds of complete remission off therapy.

Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Drug developer Biocad received approval for its rituximab biosimilar, BCD-020 (Acellbia) in Russia in 2014, and since that time, the drug has been launched in Russia and in multiple other markets around the world. While Biocad has not specified whether it plans to pursue regulatory approval for the biosimilar in the European Union, the company has announced ambitions to enter the EU market with some of its products, and researchers have published new data for the biosimilar in both oncology and rheumatology indications.

Amgen and pharmacy benefit manager (PBM) Abarca this week announced that they have entered into an outcomes-based contract for brand-name etanercept, Enbrel.

A recent study assessed tofacitinib versus anti–tumor necrosis factor (anti-TNF) agents using data from the Corrona registry, a large, prospective, observational database of patients with rheumatoid arthritis (RA) in more than 174 practices in 41 US states.

The issue of whether to switch patients currently taking biologics to biosimilars has been playing out in Canada over the past week, as mandated switching begins in British Columbia, while a reference product maker fights against a possible similar change in 2 other provinces.

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

The lead author said the results indicate that biologics can be used in older patients with rheumatoid arthritis (RA) as effectively as in those who are younger.