Search results for: biosimilars

FDA Approves Amgen’s Infliximab Biosimilar Treatment

Reuters Staff | December 10, 2019

(Reuters)—The U.S. Food and Drug Administration on Friday approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade (infliximab), according to the regulator’s website. The biosimilar, Avsola (infliximab-axxq), has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders. The label for the…

The ARP Aids Rheumatology Workforce Expansion Via Online Education

Benjamin J. Smith, PA-C, DFAAPA, Sonam Kiwalkar, MD, & Aileen Ledingham, PT, PhD, on behalf of the ARP eLearning subcommittee | November 17, 2019

The Advanced Rheumatology Course (ARC) carries the distinction of being the first online educational product of the ACR/ARP. In the early 2000s, members of the College thoughtfully considered action needed to efficiently prepare health professionals looking to enter the rheumatology workforce. A decision was made to create online educational products with the specific target audience…

A Farewell Message from Outgoing Government Affairs Committee Chair Angus Worthing, MD, FACR, FACP

Angus Worthing, MD, FACP, FACR | November 7, 2019

A farewell message from outgoing Government Affairs Committee Chair Angus Worthing urges ACR/ARP members to advocate for the rheumatology profession.

Ellen M. Gravallese, MD, Begins ACR Presidency

Susan Bernstein | November 7, 2019

As Ellen M. Gravallese, MD, begins the ACR presidency, her goals include workforce expansion, improved access to care and support for members in all areas of practice.

Drug Pricing Bills Move Forward

Angus Worthing, MD, FACP, FACR | September 20, 2019

This week, the U.S. House of Representatives released a long-anticipated plan that contains provisions to reduce U.S. drug prices according to an international price index.

FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)

Michele B. Kaufman, PharmD, BCGP | September 16, 2019

Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…

Updates to Axial Spondyloarthritis Guideline

Carina Stanton | September 5, 2019

A 2019 update of the ACR’s previous clinical practice guideline on axial spondyloarthritis is now available online. Lead investigator Michael Ward, MD, shares advice for implementing the guideline updates, including those related to sequencing and tapering biologics, and knowing when to obtain images.

Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis

Mary Choy, PharmD, BCGP, FASHP | August 16, 2019

Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…

Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel

Deena Beasley | August 12, 2019

(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….

Samsung Bioepis Humira Biosimilar Wins FDA Approval

Aakash Jagadeesh Babu and Bernard Orr | July 30, 2019

(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…