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Articles tagged with "Biosimilars"

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 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…

Should Patients with Rheumatic Disease Switch from Biologic to Biosimilar?

Susan Bernstein  |  January 19, 2018

SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…

Biosimilars: Still Waiting for Promise to Materialize

Larry Beresford  |  January 17, 2018

During the 2017 ACR/ARHP Annual Meeting, advances in biosimilar treatments were abuzz. However, many speakers noted that the presence of biosimilars on the market has not yet resulted in greater access to treatment and lower drug pricing in the U.S…

Biosimilar SB2 May Work as Well as Infliximab for Rheumatoid Arthritis

Lara C. Pullen, PhD  |  January 8, 2018

In a 78-week study examining the interchangeability of infliximab with the biosimilar SB2, the treatments demonstrated long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis. Across all the study’s treatment groups, patients had similar treatment response rates, and the long-term clinical profile of SB2 was comparable with infliximab…

Pfizer’s Second Biosimilar of J&J’s Remicade Wins U.S. FDA Approval

Tamara Mathias  |  December 14, 2017

(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed…

Sen. Lisa Murkowski Addresses Rheumatologists During ACR/ARHP Annual Meeting, Tax Reform & More

Angus Worthing, MD, FACP, FACR   |  November 21, 2017

Greetings, advocates! This month’s Washington update covers how Congress’s tax proposals affect rheumatology, the ACR’s plan to fight Medicare’s adjustments to Part B drug costs in MIPS, the good news of Medicare’s new individualized biosimilar reimbursement, advances in the rheumatology-specific Alternative Payment Model and developments in Congress’s awareness about the perilous pharmacy benefit manager system….

Biosimilars Great Debate: To Switch or Not?

Susan Bernstein  |  November 17, 2017

SAN DIEGO—Should patients with rheumatic diseases switch from a biologic to its biosimilar? At the 2017 ACR/ARHP Annual Meeting’s Great Debate, held Nov. 5, two rheumatologists argued whether to switch or stay put based on safety, efficacy and potential cost savings. First to the podium to make the case for switching, Jonathan Kay, MD, tweaked…

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