April 23, 2015 The Honorable Stephen Ostroff, M.D Acting

April 23, 2015
The Honorable Stephen Ostroff, M.D
Acting Commissioner of Food and Drugs
Food and Drug Administration (FDA)
10903 New Hampshire Avenue
Silver Spring, MD 20993
!
Dear!Commissioner!Ostroff,!
!
!
We!write!to!you!today!to!commend!the!FDA!on!its!approval!of!the!first!biosimilar,!Zarxio!
(filgrastimAsndz)!and!to!offer!our!perspective!as!FDA!continues!to!formulate!a!comprehensive!
policy!regarding!biosimilars,!particularly!in!regard!to!their!naming!and!labeling.!
As!leaders!in!the!pharmacist!community,!we!have!devoted!our!careers!to!improving!the!health!
of!the!patients!we!serve,!and!we!look!forward!to!providing!them!new!treatment!options!at!
potential!cost!savings.!Collectively!we!have!134!years!of!pharmacy!experience,!nearly!a!century!
of!that!spent!teaching.!!We!count!among!us!a!former!president!of!the!American!Pharmacist!
Association!(APhA)!and!a!former!president!of!the!American!Society!of!Health!System!
Pharmacists!(ASHP).!!Last!month,!we!joined!125!other!pharmacists!and!participated!in!a!fiveA
hour!continuing!education!course!devoted!exclusively!to!understanding!biosimilarsA!the!
opportunities,!as!well!as!regulatory!challenges!they!present.!!
In!pharmacy,!protecting!the!safety!of!our!patients!is!always!the!primary!concern,!and!a!
dedication!to!clarity,!transparency,!and!accuracy!when!dealing!with!medications!is!vital!to!
fulfilling!that!duty.!The!FDA’s!longstanding!commitment!to!these!principles!is!wellAknown,!and!
we!are!extremely!pleased!to!see!that!commitment!reflected!in!the!clear!naming!of!our!first!
biosimilar.!!The!FDA’s!use!of!a!differentiating!suffix!allows!filgrastimAsndz!to!be!easily!
distinguishable!from!its!reference!product!(and!any!future!biosimilars).!
The!scientific!reality!is!that!even!two!biologics!that!are!“highly!similar”!are!not!identical,!and!
that!even!minor!differences!between!them!can!result!in!negative!effects!for!an!individual!
patient,!such!as!an!unwanted!immune!response.!Clear!naming!reduces!the!chance!for!
medication!error,!allows!the!maintenance!of!an!accurate!patient!record,!aids!in!proper!tracking!
and!attribution!of!adverse!events,!and!promotes!manufacturer!accountability!for!their!products.!
We!urge!the!FDA!to!continue!to!incorporate!these!important!safeguards!into!all!future!
biosimilar!approvals.!!
!
But!while!the!distinguishable!naming!of!Zarxio!reflects!FDA’s!commitment!to!patient!safety,!
scientific!accuracy,!clarity!and!transparency,!we!feel!that!as!currently!constituted,!its!labeling!
does!not.!!
!
First,!the!label!of!Zarxio!does!not!state!that!it!is!a!biosimilar,!or!to!what!product!it!is!similar.!It!
does!not!state!whether!or!not!FDA!has!determined!the!medicine!to!have!met!the!standard!for!
substitutability:!is!it!“interchangeable”!with!its!(unnamed)!reference!product!or!simply!
biosimilar!and!therefore!safe!and!effective!but!not!necessarily!safe!for!repeated!switching!
between!the!reference!product!and!Zarxio?!!!
Most!troubling!to!many!of!the!pharmacists!participating!in!our!course!was!the!lack!of!
transparency!in!regarding!the!data!used!to!show!its!biosimilarity.!The!label!provides!no!clinical!
or!analytical!data!used!to!demonstrate!similarity!to!reference!product.!It!does!not!state!for!
which!of!the!five!approved!indications!it!was!required!to!provide!data,!or!which!(if!any)!of!these!
approvals!were!based!on!extrapolation!rather!than!trials.!It!simply!presents!the!data!of!the!
originator!medicine!without!indicating!the!source!of!that!data.!!Were!it!to!be!found!over!time!
that!Zarxio!produces!a!different!risk!of!immunogenic!effects!in!patients!AA!lower!or!higher!—that!
information!seemingly!would!be!unavailable!to!healthcare!providers!via!the!label.!Neither!we,!
nor!our!patients,!nor!their!physicians!would!be!able!to!make!informed!treatment!decisions!
relying!on!the!label!alone.!!
Beyond!the!risk!for!a!given!patient,!there!are!risks!to!the!larger!health!community.!The!advent!of!
biosimilars!promises!to!bring!patients!new!treatments!for!serious!conditions,!at!potentially!
lower!cost.!Inadequate!information!provided!through!product!labeling!for!biosimilars!could!
potentially!undermine!confidence!in!this!class!of!products!among!healthcare!providers!who!see!
clarity,!transparency,!and!accuracy!as!critical!for!patient!safety.
As!the!FDA!drafts!its!upcoming!guidance!on!labeling,!we!strongly!urge!you!to!consider!a!
requirement!for!more!informative!labeling!of!biosimilars!as!a!reflection!of!your!agency’s!wellA
known!commitment!to!patient!safety.! Approval of these medicines is dependent on their meeting
FDA’s thoughtfully-designed standards for safety and efficacy. Assuring the ready availability this
information to prescribers and pharmacists will not only improve patient outcomes by promoting
better-informed treatment decisions, it will serve to build overall confidence in biosimilars.
Thank you for the opportunity to offer our thoughts on these matters.
Sincerely,
Philip Schneider,
Professor, University of Arizona College of Pharmacy
Former President, AHSP
Ronald P. Jordan,
Dean, Chapman University School of Pharmacy
Former President, APhA
Joseph J. Bova,
Director of Continuing Education,
Long Island University College of Pharmacy