Rheumatology

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.

The American College of Rheumatology (ACR) has issued a list of recommendations for streamlining prior authorization to eliminate redundancy and improve access for patients.

In inflammatory rheumatic diseases, the nocebo effect may account for a portion of treatment failures among patients who were placed on biosimilars; however, discontinuations due to the nocebo effect can be difficult to diagnose due to the absence of diagnostic criteria, differences in pathologic backgrounds for each disorder, and the absence of specific neurochemical and neuroimaging studies, investigators found.

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.

The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.

Previous studies demonstrating equivalence of SB4 to etanercept in pharmacokinetics and safety have used pre-filled syringes, but these devices may be difficult for some patients to use if they have reduced hand dexterity due to the challenges of living with rheumatoid arthritis.

The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

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.