Rheumatology

ACR Issues Step Therapy, Drug Pricing Position Statements

April 3rd 2019

By Allison Inserro

As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.

Fresenius Kabi Gains European Authorization to Market Adalimumab Biosimilar, Idacio

April 3rd 2019

By Kelly Davio

Article

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

Reducing the Dose of Anti-TNF Agents Appears Feasible in Spondyloarthritis

March 23rd 2019

By The Center for Biosimilars Staff

Article

Recently, a study sought to determine whether dose reductions of anti–tumor necrosis factor (anti-TNF) therapies are possible for long-term treatment of spondyloarthritis, and found that a reduced dose is noninferior to a full dose in patients in sustained clinical remission.

Cellular Response to Infliximab May Be Linked With ADA Development

March 20th 2019

By The Center for Biosimilars Staff

Article

Like all biologics, infliximab has the potential for immunogenicity, and the development of antidrug antibodies (ADAs) can lead to loss of response or hypersensitivity reactions. A newly published paper sought to evaluate the development of a cellular response to infliximab and whether such a response could predict ADA development.

US Patients Satisfied With a Switch to Biosimilar Infliximab, Study Finds

March 18th 2019

By Kelly Davio

Article

In a paper published last week in ACR Open Rheumatology, researchers reported that although patients had some concerns about safety and efficacy, overall, they were satisfied with the switch to a biosimilar.

Most Patients With AS Stop Their First Anti-TNF Therapy by Year 2, Study Finds

March 14th 2019

By The Center for Biosimilars Staff

Article

Recently, a new study sought to examine treatment patterns in US patients new to anti–tumor necrosis factor (anti-TNF) therapy, and it found that a majority of patients, particularly women, do not remain on their first anti-TNF after 2 years.

Are Concerns About JAK Inhibitors Good News for Anti-TNF Biosimilars?

March 2nd 2019

By Kelly Davio

Article

In February, the FDA issued a drug safety communication on tofacitinib (Xeljanz), an oral, small-molecule Janus kinase (JAK) inhibitor. According to the FDA communication, a clinical trial in patients with rheumatoid arthritis who were taking an as-yet unapproved 10-mg dose of tofacitinib twice each day found an increased risk of blood clots and death.

Ahead of US Biosimilar Competition for Humira, FDA to Give AbbVie's Upadacitinib Priority Review

February 20th 2019

By Kelly Davio

Article

AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.

New Research Highlights the Role of Biosimilar Etanercept in Treating Ankylosing Spondylitis

February 13th 2019

By Kelly Davio

Article

While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).

No Safety Risks Found in a Switch From Reference Rituximab to GP2013

February 8th 2019

By Kelly Davio

Article

GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.