November 15, 2012
In an article titled “Polysorbates, Immunogenicity, and the Totality of the Evidence” author Edward T. Maggio, quotes Dr. Dolinar’s testimony at the FDA pubic hearing, saying: “Unwanted immunogenicity is the preeminent safety challenge associated with all biological therapeutics and can result in unexpected and sometimes severe adverse effects. Complicating matters, side-effects may only appear in […]
October 26, 2012
The Patient Protection and Affordable Care Act passed by Congress and signed into law by President Obama in March 2010, contained a provision establishing an abbreviated pathway for the approval of biosimilars (also referred to as followon biologics, or subsequent entry biologics) in the U.S. In February 2012, the U.S. Food and Drug Administration (FDA) […]
September 18, 2012
All biologic drugs, including biosimilars, should be required to have unique names to ensure their safety, the Alliance for Safe Biologic Medicines (ASBM) said Sept. 13. ASBM released a survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution. ASBM said these policy issues remain unresolved and will have “a fundamental […]
September 7, 2012
ASBM Executive Director Michael Reilly was quoted in the FDA Week story Stakeholders Draw Biosimilar Naming Insight From Biologic Approval. Read the article.
June 18, 2012
ASBM Chairman Dr. Richard Dolinar convened a working group of Advisory Board members to discuss the elements of a physician notification policy for biosimilars that prioritizes patient safety. Read the summary.
April 18, 2012
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.
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 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 […]
August 4, 2011
Developing the Nation’s Biosimilars Program Steven Kozlowski, M.D., Janet Woodcock, M.D., Karen Midthun, M.D., and Rachel Behrman Sherman, M.D., M.P.H. New England Journal of Medicine August 4, 2011 Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious […]
July 28, 2011
Orange County Register By Thair Phillips, President, RetireSafe The biotech revolution has brought hope to millions of Americans coping with some of the most devastating medical conditions, including cancer, Parkinson’s disease and rheumatoid arthritis. New prescription drugs, known as biologics, that were born of this revolution now comprise the fastest-growing segment of the pharmaceutical market […]
