May 13, 2016
The Senate companion to last year’s 21st Century Cures Act could help biosimilars bypass a potential roadblock to patient access.
April 13, 2016
The Food and Drug Administration’s role is to determine a follow-on drug’s biosimilarity to its biologic predecessor, explained FDA’s Steven Kozlowski, MD, at Tuesday’s National Policy & Advocacy Summit on Biologics and Biosimilars.
April 6, 2016
The Food and Drug Administration approved the second U.S. biosimilar on Tuesday, clearing the drug for seven different indications.
April 4, 2016
The Food and Drug Administration has released its long-anticipated draft guidance on biosimilar labeling – but the document may leave some health care providers and patient advocates disappointed.
March 29, 2016
Two months have passed since the World Health Organization released its final proposal on naming biological and biosimilar medications.
February 16, 2016
The Food and Drug Administration could soon approve a complex biosimilar to treat eight disease states and patient groups – even though clinical testing data has been submitted for only two.
February 8, 2016
The Centers for Medicare and Medicaid Services’ billing code system for biosimilars earned it a “D-” grade at the House Energy and Commerce Health Subcommittee’s February 4 hearing on biologics.
January 28, 2016
After years of international debate, the World Health Organization has issued its final proposal embracing distinct names for biological medicines, including biosimilars.
January 21, 2016
It’s time for clarity about the prescribing information that accompanies biosimilar medications, the U.S. House Doctors Caucus told the FDA in a Dec. 21, 2015 letter.
December 10, 2015
The Biologics Prescribers Collaborative, a group representing physicians who regularly prescribe biologics, has joined the Alliance for Patient Access.
