FDA’s Second Biosimilar Approval Hints at Random Naming System
The Food and Drug Administration approved the second U.S. biosimilar on Tuesday, clearing the drug for seven different indications.
FDA’s Draft Biosimilar Labeling Guidance Falls Short on Patient Safety Measures
The Food and Drug Administration has released its long-anticipated draft guidance on biosimilar labeling – but the document may leave some health care providers and patient advocates disappointed.
Clinical practice guidelines are intended to optimize patient care, explains a new policy brief from the Institute for Patient Access.
Two months have passed since the World Health Organization released its final proposal on naming biological and biosimilar medications.
Lawmakers Air Concerns about CMS Billing Codes for Biosimilars
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.
World Health Organization Finalizes Distinct Naming Scheme for Biological Medicines
After years of international debate, the World Health Organization has issued its final proposal embracing distinct names for biological medicines, including biosimilars.
Congressional Doctors Caucus Urges FDA to Consider Physician Input on Biosimilar Labeling
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.
