Biologics/DMARDs

FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine

Michele B. Kaufman, PharmD, BCGP | May 8, 2018

The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…

International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe

Michele B. Kaufman, PharmD, BCGP | April 30, 2018

In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…

Upadacitinib Proves Superiority to Adalimumab in Phase 3 RA Study

Michele B. Kaufman, PharmD, BCGP | April 26, 2018

Initial results from an ongoing trial show that upadacitinib outperforms adalimumab in achieving ACR20 in patients with rheumatoid arthritis…

AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023

Tamara Mathias | April 8, 2018

(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…

The ACR Updates Biosimilar Position Statement

Keri Losavio | April 4, 2018

In March, the ACR released a white paper designed primarily to help rheumatologists and rheumatology health professionals gain an understanding of biosimilars.1 This research-based education piece examines the scientific, economic and prescribing issues related to the use of biosimilars. Now, the ACR has released an update to its official position statement on the use of…

DMARDs & Biologics Info for Rheumatology Nurses

Larry Beresford | March 17, 2018

SAN DIEGO—In a presentation on what rheumatology nurses should know in their daily practice about disease-modifying anti-rheumatic drugs (DMARDs) at the 2017 ACR/ARHP Annual Meeting Nov. 3–8, Jessica Farrell, PharmD, highlighted the importance of educating and counseling patients about the range of treatments and applications for rheumatologic conditions. Dr. Farrell, a clinical pharmacist at the…

The Science Behind Biosimilars

Arthritis & Rheumatology | February 27, 2018

Although six biosimilar agents have now been approved by the U.S. Food & Drug Administration for use in rheumatology, scientific, clinical, economic and prescribing questions about the use of biosimilars abound. In fact, at the 2017 ACR/ARHP Annual Meeting in San Diego, Joseph Huffstutter, MD, a rheumatologist in private practice in Chattanooga, Tenn., said that…

Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead

Michele B. Kaufman, PharmD, BCGP | February 20, 2018

The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…

Etanercept Biosimilar Is Effective, Well-Tolerated for Rheumatoid Arthritis

David Douglas | February 16, 2018

NEW YORK (Reuters Health)—The biosimilar LBEC0101 is equivalent to etanercept (Enbrel) in treating patients with rheumatoid arthritis (RA) who respond inadequately to methotrexate, according to researchers from Korea and Japan. As Dr. Yeong-Wook Song tells Reuters Health by email, “LBEC0101 is comparable in efficacy, safety and immunogenicity profile to Enbrel.” The findings, he adds, could…

Health Plans Enact Coverage Policies for Remicade & Infliximab Biosimilars

From the College | February 16, 2018

Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing…