Autoimmune Diseases

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.

Research documents that the disease affects men and women differently.

An immunotherapy combination gets a third thoracic indication; another potential indication for an SGLT2 inhibitor.

Fatigue causes a complex array of problems for people with autoimmune disease.

Study of the quality of life of psoriatic arthritis patients reveals the added burden of skin symptoms.

FDA actions for the week ending August 21, 2020, include a hearing set for a drug that could limit weight gain often associated with treatment for serious mental illness.

Celiac disease was linked with a greater likelihood to be diagnosed with a mood disorder, ADHD, or an eating disorder.

A recent study found 64% of patients with psoriatic arthritis who had tried at least one biologic stayed with Cosentyx for the entire study period.

Preliminary findings by Case Western researchers point to kallikrein-related peptidase 6 as possible culprit in the development of psoriatic arthritis.

Potential agents to battle inflammation and other processes move through development pipeline.

A look at recent developments in treatment and the cost implications of various autoimmune diseases.

The food people eat and the toxins they are exposed to on a daily basis are two of the biggest contributors to the likelihood of developing an autoimmune disease, according to many health experts.