New AfPA Video Outlines “What Physicians Need to Know to Safely Prescribe Biosimilars”
Much more than simply a sticker on a medicine bottle, drug labels – or “prescribing information”—provide physicians with crucial information about medical therapies.
Billing Code Proposal Raises Patient Safety Concerns
J-Codes, the billing codes used for medical therapies and procedures, could impact how well physicians and health care systems can monitor patient responses to biological medicines as more biosimilars enter the U.S. market.
U.S. Senators Press FDA Director on Unresolved Biosimilar Policy Issues
The Senate Subcommittee on Primary Health and Retirement Security’s September 17 hearing featuring FDA Director Janet Woodcock, MD, resulted in a packed hearing room—and hopes that FDA guidance on unresolved policy issues affecting biosimilars will materialize sooner rather than later.
Biosimilar Cost Savings Disappoint
Biosimilar cost savings have arrived. But they are proving much less robust than proponents had hoped.
IfPA Releases Policy Update on Biosimilars
Five years after the federal government approved an abbreviated regulatory pathway for biosimilars, physicians and patients still lack clarity on a number of core issues.
Australian Regulators Recommend Biosimilar Substitution without Notification
Australian pharmacists could soon substitute a biosimilar infliximab for its reference product without prescribing physicians’ –or even patients’—knowledge.
FDA Guidance Suggests Distinct Names for Biosimilars
The FDA has issued new guidance that proposes giving distinct non-proprietary names to biologics and biosimilars.
GAfPA Encourages Standards-based Guidelines for Colombia’s Biosimilars
Colombian regulators’ ill-defined “alternative approach” to approving biosimilar medicines has the country’s patients unsettled.
Airline Analogy Enlivens Biosimilar Naming Discussions
How can regulators effectively create distinguishable names for biosimilars?
WHO Faces Challenge to Develop Simple Solution to Complex Issue of Naming
On behalf of the Global Alliance for Patient Access I participated in this week’s International Nonproprietary Names (INN) Biological Qualifier (BQ) Comments Review: Front Page Meeting with Stakeholders, held at the World Health Organization Headquarters in Geneva, Switzerland.
