Greetings from Washington, D.C. Your advocacy team had another busy month. Unlike my prior updates, and in order to keep our focus on health policy, I avoid mentioning anything about Washington investigations into obstruction of justice, collusion, etc. You get enough of that elsewhere. The Healthcare Bill Obamacare repeal and reform efforts are speeding up….
The Birth and Growth of Biotechnology, and the Impact of Biologic Drugs on Rheumatology
Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure. The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the…
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…
U.K. Competition Watchdog Accuses Merck of Obstructing Biosimilars
LONDON (Reuters)—Britain’s competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade (infliximab) that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) says it had provisionally found the U.S. company’s European unit, Merck Sharp & Dohme (MSD), had abused…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
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…
As Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
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…
A New Administration Brings Updated ACR Policy Positions
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…
Switch to Biosimilar Infliximab for IBD Slashes Drug Costs
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…
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…
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