On September 26th GHLF submitted a letter to Commissioner Hamburg at the FDA written by GHLF Chief Medical Officer, Dr. Jonathan Krant. The letter explains that biosimilars are not like generic drugs. A biosimilar product is highly similar to, but not the same as it’s reference biologic product. Therefore, from a patient safety perspective, it is […]
As patients, our core concerns are to safeguard safety and the physician-patient relationship. Physicians and their patients are in the best position to determine appropriate therapies
￼In March 2010, a U.S. biosimilar pathway was signed into law as part of the Affordable Care Act (ACA). In February 2012, the Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. What, if any, additional guidance FDA may issue, and when, is uncertain.
HEALTH POLICY MEMORANDUM TO: All Medicare Administrative Services FROM: Global Healthy Living Foundation (GHLF) SUBJECT: Medicare changes threaten patient access to physician-administered therapy DATE: September 19, 2013 The Global Health Living Foundation (GHLF) is the umbrella organization for the arthritis advocacy group “CreakyJoints” and its membership of almost 56,000 nationwide. Most of these people are […]