February 14, 2012
The Alliance for Safe Biologic Medicines will host its third webinar on biologic and biosimilar medicines on Thursday, February 16, 2012. Click here to register! The webinar will be hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Pharmacovigilance 101: What is it and why is it important? Thursday, February 16, 3:00 PM ET […]
February 9, 2012
The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said […]
January 24, 2012
By Andrew Spiegel, Chief Executive Officer of the Colon Cancer Alliance (CCA) MedCity News The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990. These promising reductions in the […]
January 4, 2012
By Helena R. Berger Florida Sun Sentinel January 4, 2012 A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and […]
December 21, 2011
By John Horton Huffington Post Seventeen years ago, Ronald Reagan penned what some have called his “Long Goodbye”: a letter to the American people announcing that he had been diagnosed with Alzheimer’s disease. He poignantly thanked readers for allowing him to serve as president. “I only wish there was some way I could spare Nancy […]
December 15, 2011
By Dr. Marcy Zwelling-Aamot, chairperson of the Board of the American Academy of Private Physicians (AAPP) The Hill The U.S. Food and Drug Administration (FDA) is holding an important public meeting today on its proposed biosimilar user fee program recommendations. This meeting is a major step in making biosimilars available for the first time in […]
December 7, 2011
Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity By Bryan A. Liang and Timothy Mackey Therapeutics and Clinical Risk Managment Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient […]
November 12, 2011
Alliance for Safe Biologic Medicines Launches Webinar Series Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free! Biologics 101: What are biologics and why should you care? Thursday, November 17, 2:30 PM EST Click here to […]
November 4, 2011
By Bruce Rubin MedPage Today Although politicians and patients may debate the benefits and drawbacks of the U.S. healthcare system, when it comes to inventing new medical technologies and discovering life-saving treatments, no other nation matches the U.S. in terms of innovation and delivery of care. One reason the U.S. is so successful is that […]
October 6, 2011
The FDA’s Janet Woodcock recently appeared on BioCenturyTV and in a web exclusive she addresses a potential ‘biosimilars pathway’. Though she declined to comment on the specific clinical and nonclinical standards, she made clear that the approval pathway for a biosimilar is different from that of a biologic. She also said that biosimilar interchangeability is […]
