On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
Trio Wins Chemistry Nobel for Work on Antibody Drugs & Detergents
STOCKHOLM/LONDON (Reuters)—Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to generate novel proteins used in everything from environmentally friendly detergents and biofuels to cancer drugs. The fruits of this work include the world’s top-selling prescription medicine – the antibody injection Humira sold by…
California Insurance Commissioner Sues AbbVie over Humira
(Reuters)—On Tuesday, Insurance Commissioner Dave Jones filed a complaint on behalf of the State of California against AbbVie Inc., alleging the drugmaker gave illegal kickbacks to healthcare providers to prescribe its blockbuster drug, Humira. The regulator alleged that AbbVie engaged in a far-reaching scheme including cash, meals, drinks, gifts, trips and patient referrals, as well…
Study Says 1 Biosimilar Switch Is OK; Jury Still Out on Multiple Switches
AMSTERDAM—As more biosimilar drugs for rheumatic diseases make their way to market, evidence is growing that switching from the originator drug to a biosimilar tends to be effective, while the questions of switching back and forth, and switching multiple times using several different biosimilars, remain to be answered, an expert on the topic said at…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(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,…
Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead
The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
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…
Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review
The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
Express Scripts Tries to Rein in Pricey Inflammatory Drugs
NEW YORK (Reuters)—Express Scripts Holding, the largest manager of U.S. drug benefits, on Thursday launched a program aimed at tightening spending on drugs for pricey inflammatory conditions such as rheumatoid arthritis. It is the latest Express Scripts effort intended to reduce spending on prescription drugs, such as last week’s announcement of a diabetes program. Early…