PARIS (Reuters)—Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential. In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells. They are seen as a promising answer in…
Rheumatologists Concerned High Healthcare Costs May Encourage Patients to Forgo, Delay Treatment
While members of Congress debate healthcare legislation, rheumatologists say many of their patients struggle to afford everything from generic drugs to insurance copayments for physical therapy. “It’s a mess. The cost of prescriptions and the rationale for those rising costs in the U.S. right now—it’s just a mess,” says James R. O’Dell, MD, Stokes-Shackleford Professor of…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
Physician’s Choice: Factors That Influence First- & Second-Line Biologic Therapy in RA Patients
In patients with RA, age and higher rates of comorbidity are influential in selecting and changing treatments…
Biosimilars to Raise Unique Questions
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…
Tips, Resources to Help Rheumatologists Educate Patients on Biologics and Biosimilars
Rheumatologists are accustomed to educating patients about medications—but biologic medications 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. “This includes the patient’s disease activity, prior medications…
U.S. Supreme Court to Hear Dispute Over Biologic Drug Sales
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…
New Test Yields Rapid Infliximab Drug Concentrations
NEW YORK (Reuters Health)—A new test provides rapid infliximab drug concentrations that enable immediate dosing adjustments, researchers from Belgium report. “With this rapid test, our biggest wish is to persuade physicians to now perform and use infliximab measurements also in their own daily clinical practice, as many practical and organizational issues that went along with…
Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs
Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…
New Treatment Guidelines to Be Presented at the 2016 ACR/ARHP Annual Meeting
Two sets of guidelines—one on managing anti-rheumatic drugs perioperatively for patients undergoing total hip and knee replacements, and another that updates glucocorticoid-induced osteoporosis prevention and treatment strategies—will be featured in sessions at the 2016 ACR/ARHP Annual Meeting this month. The Sessions Sunday, Nov. 13, 2:30–3:30 p.m.: Glucocorticoid-Induced Osteoporosis Prevention and Treatment: A New ACR Clinical…
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