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25. Dr. Raffaella Balocco - World Health Organization
 

25. Dr. Raffaella Balocco - World Health Organization

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“Naming of biological products: Future perspectives and WHO position”

“Naming of biological products: Future perspectives and WHO position”

Illustrates the current INN system and ongoing discussions concerning the naming of biosimilars

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  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013
  • World Health Organization जून 20, 2013

25. Dr. Raffaella Balocco - World Health Organization 25. Dr. Raffaella Balocco - World Health Organization Presentation Transcript

  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Naming of biological products:Future perspectives and WHO positionDr Raffaella Balocco Mattavelli, Manager of the INN Programme
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Introduction to INN Programme"Some activities undertaken by WHO are largelyinvisible, quietly protecting the health ofevery person on this planet, every day. Byassigning a single international name to drugs,WHO helps ensure that a prescription filledabroad is what doctor ordered back home."Dr Margaret Chan, Director General – Workingfor Health: An introduction to the WHO
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013WHO some basic facts 193 Member States Two governing bodies:– World Health Assembly– Executive Board WHO Secretariat:– HQ– six Regional Offices– WHO Expert Panels(e.g. on the International Pharmacopoeia and Pharmaceutical Preparations etc.)– Constitution 1946, in force since 7 April 1948 (World Health Day) Article 2 (u) International standards
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013The WHO International Nonproprietary Name (INN) ProgrammeTo provide one single name worldwide for activepharmaceutical substancesInitiated in 1950 by resolution WHA3.11Operational since 1953Based on WHO ConstitutionInsulin human (48)(22)
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013The WHO International Nonproprietary Name (INN) Programme WHO has responsibility to develop, establish and promoteinternational standards for pharmaceutical and biologicalproducts Need for universally available and accepted name for drugsubstance INN is a unique generic name that is recognized globally and ispublic property Intended for use in drug regulation, prescription,pharmacopoeias, labeling advertising, scientific literature
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Interested parties outside WHOUSAN ProgramPharmacopoeias(BP, FP, JP….)European Commission,WCO, WIPO, …Research basedindustryNational trade-markauthoritiesDRAs(EMEA, US-FDA….)INN Programme
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013International Nonproprietary Name (INN) ProgrammeWhats in a name?SafetyQualityInformationRegulationRational useProcurementEfficacy
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013INNs…unique namedistinctive in sound and spellingnot liable to confusion with other names in common useformally placed by WHO in the public domain, (hencetheir designation as nonproprietary)can be used without any restriction to identifypharmaceutical substances
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013The INN SystemWHO SecretariatINN Expert Group– Can call on further experts if necessary– INN Advisory Group on BiologicalsPublications
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Medicines on the market New medicines in development)EuropeanCommission2005(The number of Bio. INN requests hasbeen increasing
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Current INN position for biological products20 biological groups with stems5 groups with an INN nomenclature schemeGenerals policies developed for 10 groups of biologicalproductsINN for biological and biotechnological substances areviewhttp://www.who.int/medicines/services/inn/INN_Biorev11-06.pdf
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013General policiesBlood products natural excludedFusion proteinsGene therapy productsGlycosylated proteins/peptidesNon-glycosylated proteins/peptidesImmunoglobulins excludedMonoclonal antibodiesSkin substitutes excludedTransgenic productsVaccines most excludedCell therapy products under discussion
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Existing INN stems for biological andbiotechnological substancesName of the group Stem Name of the group Stemantisense oligonucleotides -rsen pituitary hormone-release inhibiting peptides -relixblood coagulation cascade inhibitors -cogin interleukin receptor antagonists -kinrablood coagulation factors -cog interleukin type substances -kincolony stimulating factors -stim monoclonal antibodies -mabenzymes -ase oxytocin derivatives -tocinerythropoietin type blood factors -poetin peptides and glycopeptides (for special groups ofpeptides see -actide, -pressin, -relin, -tocin(-tidegrowth factors -ermin pituitary hormone-release stimulating peptides -relingrowth hormone derivatives som- receptor molecules, native or modified (apreceding infix should designate the target(-ceptheparin derivatives including lowmolecular mass heparins-parin synthetic polypeptides with a corticotropin-likeaction-actidehirudin derivatives -irudin vasoconstrictors, vasopressin derivatives -pressin
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Glycosylated proteins/peptidesIdentify the group with a stem (-poetin)Indicate differences in the amino acid sequence with arandom prefix (darbepoetin alfa)Indicate differences in the glycosylation pattern with aGreek letter in full as second word (epoetin alfa, beta,gamma, delta, etc)Greek letters assigned in the alphabetical sequence asapplications received
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Biosimilars – considerations The concept of biosimilar is a regulatory one. Generic substitution and reimbursement are health policy matters. Decision on interchangeability is not done by WHO. INNs are part of the pharmacovigilance system. There is no specific INN policy for biosimilars (currently). Glycosylated proteins from different sources expected to differin their glycosylation profile so are given distinct names; the sameapproach is valid for all the other post-translational modifications.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Naming of Similar Biotherapeutics ProductsThe WHO INN Programme exists to facilitate theidentification of medicines so that they:– have a unique name that is globally recognised; and– are prescribed and used rationallyAt present SBPs are not specifically named, but thegeneral naming principles are applied.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Current WHO policyIn practice, this means that: some SBPs (all unglycosylated, like somatropin and filgrastim)have the same nonproprietary name as the reference substance; glycosylated SBPs are likely to have different nonproprietarynames to the reference; different interpretations of this policy has led to differentcountries having different nonproprietary names for the sameproduct; and when different nonproprietary names are used, the referencesubstance to which the SBP was compared is not identified.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Current WHO policyIssue Generics SBP Type 1 SBP Type 2 Non-SBPQualitycharacteristicsSame Highly similar &cannot bedistinguished fromreference byanalytical qualitytesting.Comparable toreference, butsignificantdifferences inanalysedparameters.Not comparableAmino acidsequenceN/a Same Same Similar todifferentPost-translationalmodificationN/a Highly similar Similar to different DifferentEfficacy - safety Bioequivalent Comparable Comparable Similar todifferentINN Same INN asreferenceSame INN asreferenceSame INN stemwith Greek letterDifferent INN
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Need for naming SBPsIt is the near universal opinion of regulatory bodies that switchingarbitrarily between SBPs and their reference product or betweenSBP and SBP without medical supervision is undesirable.Means to distinguish SBPs from each other ?As prescription by nonproprietary name is common, and in somecountries encouraged, the issue of the naming of SBPs does affectthe INN Programme
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Naming SBPs an INN issue?Naming SBPs directly affects the purposes of the WHO INNProgramme in two ways:1.If the reference and SBP INNs are the same, it may makesubstitution of SBPs for the reference substance more likely (notless) and, worse still, the substitution for one SBP by another.2.If individual regulatory bodies develop their own naming policy forSBPs, there will a diversity in names, not “a unique name that isglobally recognised”.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Proposed INN naming of SBPsIt is therefore under discussion a proposal that all SBPs should beclearly identified:1.All SBPs should have the INN of the reference product as thefirst part of the name. This effectively and unambiguouslyidentifies the reference product for that SBP.2.The second part of the name should identify the medicine as aSBP and uniquely identify the product.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Proposed INN naming of SBPsThere has also been some discussion about how the naming of SBPsshould be implemented. The most viable options are:1.The second part of the name is assigned by the INN Programmeaccording to an agreed policy;2.The INN Programme produces an advice document laying out anagreed naming scheme which may be applied by national regulatoryauthorities.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013ConclusionThe naming of SBPs is an issue that does need tobe addressed globally, and soon - while thenumber of registered SBP’s is relatively small.The WHO INN Programme has a clear mandate.
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Current challenges The complexity of substances The number-induced difficulty The emerging of new types of substances (new policies?) Identifier for SBP? International set of standards?
  • Dr Raffaella Balocco Mattavelli, INN Programme ManagerInternational regulatory Workshop Biotherapeutic MedicinesMoscow, 15-16 May 2013Thank you-спасибоMerci! Obrigado !  Gracias 谢谢!ありがう! ARIGATOU ! Danke! Dziękuję! Dank je /u! Mulţumesc! Teşekkür ederim! Tack!Tack så mycket Grazie! Kiitos! ‫לך‬ ‫תודה‬! Takk!ďakujem, ďakujem vám ; Hvala! ‫شكرا‬!shokran Ευχαριστώ!  감사합니다 Děkuji! Takskal du have! Dankon! Hvala, Hvala lepa, Najlepša hvala Gràcies! Faleminderit Hvala!Ačiū, De’koju, Labai ačiū ขอบคุณ ; ขอบคุณมาก(khàwp khun) ; (khàwp khun mâak)shukrīya ( (‫شكريه‬ ‫بہت‬ (bahut) Cảm ơn cô ; Cảm ơn cô nhiều; Благодаря!Благодаря!Obrigado!” Gracias Þakka þér! baie dankie ; Takk fyri! Sipas dekem ‫متشکرم‬! Благодарам!  Hvala Vam! V Təşəkkür Paldies!Pateicos! / Tencinu! Terima kasih Дужедякую ;Дякую ; Спасибі! Баярлалаа ; Гялайлаа ; Танд их баярлалаа  Terima kasihধনয্বাদ (dhonyobād) Salamat! Trugarez ! Mersi !Trugarez Danke!http://mednet.who.int/innprogramme@who.inthttp://www.who.int/medicines/services/inn/en/index.html