November 17, 2011
Presented by Alliance Chairman, Dr. Richard Dolinar, MD
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 Register!
Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST
Click here to register!
Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST
Click here to register!
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 Register!
Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST
Click here to register!
Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST
Click here to register!
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 our regulatory system fosters the right balance between the need to ensure patient safety and the desire to produce cost-effective treatments.
Yet, the Food and Drug Administration is currently faced with another issue that will test its ability to find that balance.
The 2010 healthcare reform bill included a provision calling on the FDA to create an expedited pathway for approving biosimilars — the nonidentical “generic” versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis. The FDA may issue guidance on the subject any day now.
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 “feasible” for certain products.
Watch the two shows here
October 5, 2011
By Kathy Feegal
Dr. Richard Dolinar, the Alliance’s chairman, was a keynote speaker at a biosimilars roundtable discussion in Boston, MA on October 5, 2011. The event was hosted by Northeastern University and was attended by numerous stakeholders from across New England, including the Massachusetts Medical Society, and patients groups such as the National Kidney Foundation; American Cancer Society; AIDS Action; as well as elected officials and policymakers from the state legislature.
October 5, 2011
Dr. David Charles, Chairman, Alliance for Patient Access
The Tennessean
In 1993, a drug just approved by the Food and Drug Administration was highlighted in a Fortune magazine article under the eye-catching headline “Fortune Products of the Year.”
The drug was Betaseron. And while the headline was ambitious, the new drug was a medical triumph. It provided doctors with the first successful treatment for multiple sclerosis, a progressive and disabling neurological disorder that often strikes in the prime of life.
But even more important than Betaseron’s clinical success is its origin. It belongs to an exciting new category of drugs known as “biologics.” These medical breakthroughs are manufactured from living biological processes instead of the more basic chemical processes used to produce conventional pharmaceuticals. Betaseron was one of the world’s first modern-day biologics and it changed the course of medicine forever.
October 5, 2011
Dr. David Charles, Chairman, Alliance for Patient Access
The Tennessean
In 1993, a drug just approved by the Food and Drug Administration was highlighted in a Fortune magazine article under the eye-catching headline “Fortune Products of the Year.”
The drug was Betaseron. And while the headline was ambitious, the new drug was a medical triumph. It provided doctors with the first successful treatment for multiple sclerosis, a progressive and disabling neurological disorder that often strikes in the prime of life.
But even more important than Betaseron’s clinical success is its origin. It belongs to an exciting new category of drugs known as “biologics.” These medical breakthroughs are manufactured from living biological processes instead of the more basic chemical processes used to produce conventional pharmaceuticals. Betaseron was one of the world’s first modern-day biologics and it changed the course of medicine forever.
September 28, 2011
The Alliance for Safe Biologic Medicines joined with the Virginia Biotechnology Association at an event to expore with patients, advocates, physicians and other healthcare providers the importance of maintaining patient safety as the U.S. FDA’s top priority while it works to establish a pathway for approval for biosimilar products. Continue reading…
September 10, 2011
By Kara Nett Hinckley, Public Policy Coordinator, Colorado Chronic Care Collaborative
Denver Post
How many of us have watched a loved one or friend suffer from a serious illness and wished for a miracle treatment that could help them with their struggle? Biologic drugs are not miracles, but they are a new, often better way of treating many life threatening conditions and chronic diseases. As the Food and Drug Administration outlines the regulatory pathway to replicate biologics – a process that is distinct from creating generic pharmaceuticals – we must ensure proper measures are in place to uphold their safety and effectiveness.
Chronic disease is one of the most challenging and costly healthcare issues in America. In Colorado, one in four – some 1.2 million citizens – live with a chronic disease like diabetes or Multiple Sclerosis.
The 2010 Affordable Care Act instructed the FDA to outline an approval process for replicated biologics, called biosimilars, following Europe who has worked on a similar framework since 2004.
