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