The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

October 17, 2017 • By Mary Beth Nierengarten

  • Tweet
  • Email
Print-Friendly Version / Save PDF
ajt/shutterstock.com

ajt/shutterstock.com

FDA Approves Adalimumab-adbm

On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate to severe polyarticular juvenile idiopathic arthritis in patients age four years and older, moderate to severe active adult Crohn’s disease and moderate to severe active ulcerative colitis.

You Might Also Like
  • FDA Update: Biosiomilar to Adalimumab Receives FDA Approval
  • FDA Committee Recommends Tofacitinib Approval
  • FDA Responds to New Drug Application for Baricitinib
Explore This Issue
October 2017
Also By This Author
  • Mesenchymal Stem Cell Therapy May Help Slow, Repair Degenerative Signs of Osteoarthritis, Musculoskeletal Disease

Cyltezo is not yet commercially available, and its maker, Boehringer Ingelheim, is currently engaged in patent litigation with AbbVie, which manufactures Humira.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Baricitinib’s Status

According to Eli Lilly and Co. and Incyte Corp., the makers of baricitinib, the new drug application for baricitinib will be refiled with the FDA before the end of January 2018.2 This resubmission will included new safety and efficacy data. Baricitinib is a once-daily oral investigational drug for treating patients with moderate to severe RA.

In April 2017, baricitinib’s potential approval to treat RA in the U.S. stalled when the FDA sent a complete response letter to the previous new drug application. The FDA declined to approve the treatment, citing that additional clinical data were needed to determine the most appropriate doses and the need for additional data to further characterize safety concerns.3 Baricitinib was approved for use in the European Union in February 2017 and in Japan in July 2017.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Additionally, baricitinib is being studied to treat atopic dermatitis and systemic lupus erythematosus. Phase 3 clinical trials for psoriatic arthritis are scheduled to begin in 2018.

Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis & ankylosing spondylitis, & moderate to severe plaque psoriasis.

FDA Committee Approves Tofacitinib for PsA

On Aug. 3, the Arthritis Advisory Committee of the FDA voted 10–1 to recommend the approval of the proposed dose of tofacitinib for treating adults with active psoriatic arthritis (PsA). Supplemental new drug applications for 5 mg tofacitinib taken twice daily and extended-release 11 mg tofacitinib taken once daily are pending for this indication.4,5

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

The FDA’s final decision on whether to approve tofacitinib for PsA is anticipated by December 2017.

Bimekizumab Investigational for Psoriasis

Bimekizumab is a monoclonal antibody designed to potently and selectively neutralize both interleukin (IL) 17A and IL-17F cytokines. In the Phase 2b BE ABLE study, the safety, efficacy, pharmacokinetics and pharmacodynamics of bimekizumab were compared with placebo in adult patients with moderate to severe chronic plaque psoriasis.6

Pages: 1 2 | Single Page

Filed Under: Biologics & Biosimilars, Conditions, Drug Updates, Spondyloarthritis Tagged With: adalimumab, Ankylosing Spondylitis, Approvals, baricitinib, Bimekizumab, Biosimilars, drug update, efficacy, FDA, Humira, plaque psoriasis, Psoriasis, Quality, RA, Rheumatoid arthritis, rheumatology, Safety, TofacitinibIssue: October 2017

You Might Also Like:
  • FDA Update: Biosiomilar to Adalimumab Receives FDA Approval
  • FDA Committee Recommends Tofacitinib Approval
  • FDA Responds to New Drug Application for Baricitinib
  • Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More

Patient & Caregiver Resources

Find a rheumatology provider. Learn about your condition and how to live with it. English and Spanish language resources.

View Patient & Caregiver Resources »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)