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) […]
One biosimilar developer is pushing FDA to address how changes to innovator biologics over time could affect biosimilar products that reference them, advocating for the agency to use comparability standards as a basis for determining biosimilarity, allow biosimilar determinations based only on one version of an innovator product if drift occurs and investigate ways to […]
86% of physicians responding to a new US survey say they want to be notified before a patient is switched to a different biologic product than the one prescribed, even if there are no known concerns associated with it. And 85% of physicians responding to the poll said that they want to have the authority […]
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 […]
The Alliance for Safe Biologics released a new survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution – policy issues that remain unresolved and will have a fundamental impact on patient safety. Over 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists – all specialties that prescribe biologics – responded to […]
ASBM Executive Director Michael Reilly was quoted in the FDA Week story Stakeholders Draw Biosimilar Naming Insight From Biologic Approval. Read the article.
On September 6, Dr. Dolinar presented an overview of biologics and biosimilars at the Florida Association of Health Plans Annual Conference. View his FAHP Presentation
The Alliance for Safe Biologic Medicines (ASBM) will host a series of roundtables beginning in September to seek input from the patient, physician and pharmacist communities on the issue of physician notification for biosimilars. The roundtables seek to build on the May 24th ASBM Advisory Board physician notification working group meeting led by Chairman Richard […]
Good piece on biosimilars in Forbes by Jon Entine, Senior Fellow at the Center for Health & Risk Communication at George Mason University. Read FDA Balances Costs, Patient Safety in the Biologics and Personalized Medicine
On July 9, President Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act, that reauthorizes FDA user fees and that will establish new user-fee programs for biosimilar drugs. Read more.