WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
LONDON (Reuters)—European drugmakers, faced with increasing competition from cut-price copies of complex biotech drugs, cautioned doctors on Thursday to take care when switching patients from an established product to biosimilar version. The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But…
The ACR continues to broaden its advocacy efforts on issues critical to rheumatology, as described in updates to its 2017 health policy statements. Along with continuing to advocate for access to care and treatments, enhancements to rheumatology research and training the next generation of rheumatologists, the 2017 health policy statements address a number of new…
NEW YORK—Inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab to biosimilar infliximab using a managed-switching program, U.K. research shows. “Thus far, there does not appear to be any significant difference between the two infliximab products in terms of drug persistence, side effects, adverse reactions, disease activity, or blood tests, but ongoing…
Rheumatologists are accustomed to educating patients about medications, but biologic medications—and now biosimilars—require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. The first FDA-approved biosimilar to become…
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has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development.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…
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
Opportunities and challenges will continue to face the rheumatology community in 2017. In response to these challenges, the ACR has outlined its federal– and state-level legislative and regulatory healthcare priorities for the year. Howard Blumstein, MD, chair of the ACR Affiliate Society Council, says that achieving at least some of these priorities at the state…
NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market. The justices opted not to take up Apotex Inc.’s appeal of a July federal appeals court ruling that could…