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Top five stories about biosimilars
Healio Rheumatology has compiled a list of the five top stories on our site about the use of biosimilars for rheumatology.
Adalimumab biosimilar showed similar safety, efficacy as reference product in patients with RA
The adalimumab biosimilar ABP 501 showed similar safety, efficacy and immunogenicity as adalimumab in patients with rheumatoid arthritis (RA), according to a recently published analysis. Read More.
FDA issues draft guidance on biosimilar interchangeability
The FDA has released a draft guidance for industry that outlines criteria for demonstrating that a biosimilar is interchangeable with a reference product under section 351 (k) of the Public Health Service Act. Read More.
Research shows biosimilar adalimumab meets efficacy of Humira
A phase 3 study met its primary endpoint of demonstrating that Sandoz’s GP2017, a proposed biosimilar adalimumab, has equivalent efficacy to Humira in treating moderate to severe chronic plaque psoriasis, according to results presented at the American Academy of Dermatology Annual Meeting in Orlando, Fla. Read More.
CMS issues payment information for biosimilar Inflectra
CMS has included payment information for Inflectra, the FDA-approved biosimilar to Janssen’s Remicade, in its January Average Selling Price pricing file, Pfizer announced. Read More.
VIDEO: Bibila reviews accomplishments of biosimilars from Merck
WASHINGTON — At the American College of Rheumatology Annual Meeting, Dora Bibila PhD, general manager of biosimilars at Merck, reviewed the company’s accomplishments with biosimilars. Read More.