NEW YORK (Reuters)—A group of Democratic senators took their plans to tackle rising drug costs to President-Elect Donald Trump on Tuesday, asking him to work with them and Republicans on the issue. In a letter dated Tuesday, the 19 senators named five areas for cooperation: allowing the Medicare program to negotiate prescription prices, increasing transparency,…
Search results for: biosimilars
U.S. Supreme Court Declines to Hear Biologic Drug Patent Fight
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…
New GAC Chair Picks up the Baton
It’s an honor and a thrill to be the next chair of the Government Affairs Committee. Boy, do we have a big year ahead.
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…
ACR President Dr. Joan Von Feldt Reflects on Her Year in Office, Advancing Rheumatology!
This has been a year of tremendous growth, change and achievement for the ACR, and I have been fortunate to lead the ACR in these endeavors. The ACR and ARHP, including the ACR Executive Committee, the ACR Board of Directors, standing and special committee chairs and hundreds of dedicated volunteers, have contributed to this growth…
The Fight Against the Medicare Part B Demonstration Project
The ACR and 315 other organizations have publicly said savings would not be achieved by the demonstration project and that it will reduce access to care for patients…
Shifting Health Policy Landscape Brings Opportunities, Responsibility to Advocate for Rheumatology
Heraclitus of Ephesus (c. 500 BC) is credited with the saying, “The only constant is change.” Now, centuries later, change is meteoric, and especially in healthcare and health policy, the pace of change is relentless. Rheumatology and other specialties continue to face challenges that threaten the ability to deliver compassionate, competent care to patients. The…
Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…
Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing
The use of biosimilars for rheumaÂtology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…
Understanding Prescription Pathways for Biologic Medication Therapy
Executing evidence-based medicine in the U.S. is challenging, especially utilizing high-cost medications in rheumatologic care. As patients trust their clinicians to be their medical experts, clinicians must trust their care team members to be experts at implementing the care plan. A clinician’s knowledge of human anatomy and physiology is the foundation to understanding pathophysiology. From…
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