February 27, 2012
By Richard Dolinar A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex […]
February 27, 2012
Capitol Hill Biosimilars Policy Forum Discusses Recent FDA Guidances Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, partnered with Bloomberg Government to host “Biosimilars Policy Forum: Keeping Patients Safe” on February 27, 2012. The event followed the release of […]
February 22, 2012
Alliance to Host Capitol Hill Forum The Alliance for Safe Biologic Medicines and Bloomberg Government will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development. Panelists include: Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator) Dr. Richard Dolinar, […]
February 15, 2012
The National Physicians Biologics Working Group today released an educational video featuring a discussion about the benefits of biologic therapies and how they differ from conventional pharmaceuticals. In the four minute video, David Charles, M.D., Chairman of the Alliance for Patient Access, discusses the importance of formulating public policies that ensure access to these biologic […]
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The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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 9, 2011
Robust clinical trials will ensure that biosimlars are safe and effective for patients Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, welcomes the first steps from the U.S. Food and Drug Administration (FDA) to bring biosimilars on the market […]
