The Rheumatologist
COVID-19 News
  • 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
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • 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 / Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone

Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone

February 4, 2019 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

Canada Approves Erelzi for Psoriatic Arthritis
Health Canada has approved Erelzi, a biosimilar to Enbrel (etanercept), for treating psoriatic arthritis (PsA) in adults.1 In Canada, Erelzi is the only biosimilar to etanercept to obtain approval for this indication. In April 2017, Health Canada initially approved Erelzi to treat moderate to severe active rheumatoid arthritis in adults, polyarticular juvenile idiopathic arthritis in patients aged 4–17 years old and ankylosing spondylitis.

You Might Also Like
  • Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
  • IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
  • U.S. FDA Approves Biosimilar to Etanercept
Explore This Issue
March 2019
Also By This Author
  • Upadacitinib Promising for RA in Phase 3 Study

Dated Jan. 17, the Notice of Compliance from Health Canada states Erelzi can be used to reduce the signs and symptoms of PsA, inhibit the progression of structural damage of active arthritis and improve physical function in adults with PsA. Additionally, the treatment can be used in combination with methotrexate in adults who do not adequately respond to methotrexate monotherapy.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Erelzi is available in a pre-filled syringe in 25 and 50 mg doses. It is also available in a pen designed for patients with limited dexterity.

FDA Moves to Increase Access to Naloxone
Naloxone is designed to treat drug overdoses in an emergency situation. But the agent requires a prescription, which may be a barrier for patients who are not under a physician’s care. This requirement may also prevent individuals with substance abuse problems and those close to them from accessing it to prevent an overdose. The U.S. Food and Drug Administration (FDA) is currently working to make naloxone available over the counter (OTC), which may improve access.2

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

In an attempt to encourage pharmaceutical manufacturers to enter the OTC market for naloxone, the FDA has taken the unprecedented step of proactively developing and testing a Drug Facts Label, which is required for all OTC drug products. This action is part of the agency’s commitment to address the opioid crisis.

For naloxone, the Drug Facts Label has easy-to-understand pictograms demonstrating how to administer the treatment. Additionally, the FDA conducted label comprehension testing to ensure the instructions were easy to follow. The agency has designed, tested and validated key labeling requirements necessary to approve an OTC naloxone, which will aid interested pharmaceutical companies with their OTC naloxone labeling.


Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

References

  1. Sandoz Canada Inc. News release: Sandoz Canada receives Health Canada approval for Erelzi (etanercept) in the treatment of psoriatic arthritis (PsA) in adult patients. FirstWord Pharma. 2019 Jan 21.
  2. U.S Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths. 2019 Jan 17.

Pages: 1 2 | Single Page

Filed Under: Analgesics, Drug Updates Tagged With: Biologics & Biosimilars, biosimilar, Canada, etanercept, FDA, generic drug market, naloxone, opioid, Opioid abuse, Psoriatic Arthritis, U.S. Food and Drug Administration (FDA)Issue: March 2019

You Might Also Like:
  • Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
  • IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
  • U.S. FDA Approves Biosimilar to Etanercept
  • FDA Approves Opioid Treatment

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 »

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

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

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

Copyright © 2006–2022 American College of Rheumatology. All rights reserved.

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