Autoimmune Diseases

Celltrion’s application is based on data from a phase 3 trial of patients with rheumatoid arthritis comparing its biosimilar with Actemra.

The IV formulation, a monthly 30-minute, weight-based dosing option, has a wholesale acquisition cost of $2,115 per vial. It will be available in the fourth quarter.

Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.

Feelings of depression and stress are partly to blame for lower fitness levels among people with rheumatoid arthritis.

The results argue for close clinical management of people with rheumatoid arthritis, say the authors of the meta-analysis that included 14 studies.

Manipulating T cells to target cancer cells has worked to treat some cancers. Researchers are investigating whether the same approach might be used to curb the dysregulated immune response that underlies autoimmune disease.

New analyses shed light on decreased hearing in people with Graves’ disease and thyroid eye disease.

Rates of Graves’ disease, celiac disease, and Sjögren’s syndrome doubled in the United Kingdom between 2000 and 2019.

Low-to-moderate doses of prednisone appear to lessen rates of nausea and other side effects in patients taking methotrexate, a new study found.

Stimulating PD-1 is a novel approach to treating rheumatoid arthritis, but the strategy could be a fit for other autoimmune diseases.

Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.

Kevzara is the first biologic to treat patients with polymyalgia rheumatica (PMR). It is also approved to treat rheumatoid arthritis.

The real impact may not likely be seen until after July when additional biosimilars referencing Humira are launched.

Some PBMs will offer Amgen’s Amjevita biosimilar as a preferred product alongside Humira, but CVS Caremark said Humira will remain preferred and Amjevita will be placed on a non-preferred brand tier.

A decision is anticipated in early January about which of the now eight Humira biosimilars will be included.

This is the eighth biosimilar to reference the blockbuster rheumatoid arthritis drug Humira that will launch in 2023.

The acceptance of Biogen’s application follows regulator’s acceptance of an application by Fresenius Kabi for another Actemra biosimilar.

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first PBM to make public its plans for the seven Humira biosimilars that could be introduced in 2023.

Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.

Riabni is now approved to treat all available Rituxan indications.

The FDA needs more time to assess information submitted by the company.

The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.

Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.

Telehealth during the COVID-19 pandemic has been especially important to patients with rare disorders, many of which are autoimmune diseases, according to a recent report from the National Organization for Rare Disorders.

New data presented recently at the American College of Rheumatology meeting add to the evidence in support of anifrolumab, which could address unmet need in lupus.

Rather than stopping hydroxychloroquine altogether, doses could be reduced and patients monitored if there are signs of retinopathy, say the authors of a commentary in the American Journal of Ophthalmology.

Central obesity may be especially unhealthy for people with the inflammatory condition that affects the spine.