FrancophonIA/ELRC3.0 huggingface dataset:
English: Comparability is not a new regulatory concept, but a well-established scientific principle that has been used for decades in the manufacture of medicines made by biotechnology
Slovenian: Primerljivost ni nov regulativni pojem, temveč dobro uveljavljeno znanstveno načelo, ki se že desetletja uporablja v proizvodnji zdravil, proizvedenih z uporabo biotehnologije3,4,5.
English: Suspected ADRs are those that have been reported to authorities but which are not necessarily caused by the medicine.
Slovenian: Domnevni neželeni učinki zdravila so tisti učinki, ki so bili sporočeni organom, ajih ni nujno povzročilo zdravilo.
English: Therapeutic Goods Administration (Australia's medicines regulatory authority)
Slovenian: Avstralska regulatorna agencija za zdravila (angl. Therapeutic Goods Administration)
English: Technology that relies on biological systems, living organisms or components from living organisms (such as genes or enzymes) to make a specific product.
Slovenian: Tehnologija za proizvodnjo določenega izdelka, ki temelji na bioloških sistemih, živih organizmih ali elementih iz živih organizmov (kot so geni ali encimi).
English: Comprehensive comparability studies must show that the biosimilar is highly similar to the reference medicine (by means of safety, efficacy and immunogenicity data) in a key indication in a population in which potential differences in clinical performance can be detected.
Slovenian: S celovitimi primerjalnimi študijami je treba dokazati, da je podobno biološko zdravilo visoko podobno referenčnemu zdravilu (na podlagi podatkov o varnosti, učinkovitosti in imunogenosti) pri ključni indikaciji v populaciji, pri kateri je mogoče odkriti morebitne razlike v klinični učinkovitosti.
English: The mechanism of action of the active substance should be mediated by the same receptor(s) in both the initial and the extrapolated indication.
Slovenian: V mehanizem delovanja zdravilne učinkovine morajo biti vključeni enaki receptorji pri prvotni in pri ekstrapolirani indikaciji.
English: As for any medicine, healthcare professionals should choose carefully when prescribing, taking into account the patient's medical history.
Slovenian: Tako kot pri vseh drugih zdravilih morajo zdravstveni delavci skrbno izbirati zdravila, ki jih predpisujejo in pri tem upoštevati anamnezo pacienta.
English: Monoclonal antibody 150,000 daltons
Slovenian: Monoklonsko protitelo 150 000 daltonov
English: A biosimilar can be approved for some or all of the authorised indications of the reference medicine, as a company may choose not to apply for all the reference medicine's indications.
Slovenian: Podobno biološko zdravilo je lahko odobreno za nekatere ali vse odobrene indikacije referenčnega zdravila, saj se poslovni subjekt lahko odloči, da ne bo zaprosil za odobritev vseh indikacij, ki so bile odobrene referenčnemu zdravilu.
English: PD endpoints are usually based on laboratory tests.
Slovenian: Končne točke za merjenje farmakodinamične aktivnosti običajno temeljijo na laboratorijskih preskusih.
English: A plan to manage risks always in place
Slovenian: Stalno vzpostavljen načrt za obvladovanje tveganj
English: Details of how each biosimilar was developed and on the comparability studies to demonstrate biosimilarity are given in their assessment reports.
Slovenian: Podrobnosti o tem, kako je bilo posamezno podobno biološko zdravilo razvito, in o primerjalnih študijah za dokazovanje biološke podobnosti, so navedene v pripadajočih poročilih o oceni.
English: Extrapolation is also supported by regulators' extensive experience in the routine evaluation of manufacturing changes for biologicals, most often without the need to repeat clinical studies in all indications.
Slovenian: Ekstrapolacija je podprta tudi z bogatimi izkušnjami regulativnih organov pri sistematičnem ocenjevanju sprememb v proizvodnji bioloških zdravil, pri čemer večinoma ni bilo potrebno ponoviti kliničnih študij za vse indikacije.
English: In the context of biosimilars and reference medicines, it is important for healthcare professionals to be aware of the terminology to refer to interchangeability and substitution practices in the EU.
Slovenian: V zvezi s podobnimi biološkimi zdravili in referenčnimi zdravili, je pomembno, da zdravstveni delavci poznajo terminologijo, da bi lahko primerjali različne prakse v EU glede medsebojne zamenljivosti teh zdravil in njihovega lekarniškega nadomeščanja.
English: Clinical data requirements are mainly pharmacokinetic bioequivalence studies
Slovenian: Zahteve glede kliničnih podatkov so v prvi vrsti farmakokinetične bioekvivalenčne študije
English: Demonstration of high similarity to a reference biological medicine in terms of chemical structure, biological activity and efficacy, safety and immunogenicity profile, mainly based on comprehensive comparability studies.
Slovenian: Dokaz velike podobnosti z referenčnim biološkim zdravilom v smislu kemijske strukture, biološke aktivnosti in učinkovitosti, varnosti ter profila imunogenosti, večinoma na podlagi celovitih primerjalnih študij.
English: The non-clinical and clinical data needed to approve a biosimilar are different from those needed for a biological medicine with a new active substance.
Slovenian: Neklinični in klinični podatki, ki so potrebni za odobritev podobnega biološkega zdravila, se razlikujejo od tistih, ki so potrebni za biološko zdravilo z novo zdravilno učinkovino.
English: Criteria for extrapolation
Slovenian: Merila za ekstrapolacijo
English: These include studying changes to the structure or minor variability in the protein (microheterogeneity), or how protein aggregation could occur due to components derived from the formulation or packaging.
Slovenian: To vključuje proučevanje sprememb strukture ali manjše variabilnosti beljakovine (mikroheterogenost) ali načina morebitnega nastanka agregacije beljakovin zaradi sestavin, ki so del farmacevtske oblike zdravila ali ovojnine;
English: When a company applies for marketing authorisation at EMA, data are evaluated by EMA's scientific committees on human medicines and on safety (the CHMP and PRAC), as well as by EU experts on biological medicines (Biologics Working Party) and specialists in biosimilars (Biosimilar Working Party).
Slovenian: Kadar poslovni subjekt zaprosi za dovoljenje za promet pri Evropski agenciji za zdravila, podatke ocenita znanstvena odbora agencije, tj. odbor za zdravila za uporabo v humani medicini in odbor za varnost (CHMP in PRAC) kot tudi strokovnjaki EU za biološka zdravila (delovna skupina za biološka zdravila) in strokovnjaki za podobna biološka zdravila (delovna skupina za podobna biološka zdravila).
English: No clinically meaningful differences compared with the reference medicine
Slovenian: Odsotnost klinično pomembnih razlik v primerjavi z referenčnim zdravilom
English: Safety monitoring of long-term or long-latency events for biological medicines follows the same principles as for small-molecule medicines.
Slovenian: Za varnostno spremljanje dolgoročnih neželenih učinkov ali neželenih učinkov z dolgo latenco za biološka zdravila veljajo enaka načela kot za zdravila z majhnimi molekulami.
English: Examples of types of proteins in biological medicines approved in the EU
Slovenian: Primeri vrst beljakovin v bioloških zdravilih, odobrenih v EU
English: previous knowledge of immunogenicity: for biological medicines with a low immunogenicity profile (e.g. filgrastim), patients are usually tested for antibodies frequently at the beginning and at the end of the clinical study with a shorter follow-up period and routine pharmacovigilance measures to manage any potential risk.
Slovenian: predhodnim poznavanjem imunogenosti: za biološka zdravila z nizkim profilom imunogenosti (npr. filgrastim) paciente običajno na začetku in ob koncu klinične študije pogosto testiramo na prisotnost protiteles, s krajšim obdobjem nadaljnjega spremljanja in rutinskimi farmakovigilančnimi ukrepi za obvladovanje morebitnega tveganja.
English: The experience over the past 10 years indicates that biosimilar competition can offer advantages to EU healthcare systems, as having more treatment alternatives available is expected to improve patients' access to biological medicines with proven pharmaceutical quality.
Slovenian: Izkušnje, pridobljene v zadnjih desetih letih11, kažejo, da konkurenca povezana s prihodom podobnih bioloških zdravil lahko pomeni prednosti za zdravstvene sisteme v EU, saj razpoložljivost večjega števila terapevtskih alternativ pacientom pričakovano izboljša dostopnost bioloških zdravil z dokazano farmacevtsko kakovostjo.
English: Strict controls are always applied to ensure that, despite this variability, there is batch-to-batch consistency and that the differences do not affect safety or efficacy.
Slovenian: Stalno se izvaja strog nadzor, da bi zagotovili, da kljub tej variabilnosti obstaja konsistentnost med serijami in da razlike ne vplivajo na varnost ali učinkovitost.
English: Practice of dispensing one medicine instead of another equivalent and interchangeable medicine at pharmacy level without consulting the prescriber.
Slovenian: Praksa izdaje določenega zdravila namesto drugega enakovrednega in medsebojno zamenljivega zdravila na ravni lekarne brez posvetovanja s predpisovalcem zdravila.
English: Endpoints measuring pharmacodynamic activity (‘PD endpoints') can be used when available and when relevant for the medicine's clinical effect.
Slovenian: Končne točke za merjenje farmakodinamične aktivnosti se lahko uporabijo, če so na voljo in so pomembne za klinični učinek zdravila.
English: Biological medicines are approved on the basis of an acceptable safety profile and they should be used according to the recommendations in the summary of product characteristics (SmPC) and package leaflet.
Slovenian: Biološka zdravila so odobrena na podlagi sprejemljivega varnostnega profila in se morajo uporabljati v skladu s priporočili iz povzetka glavnih značilnosti zdravila in navodilom za uporabo.
English: It is important that healthcare professionals report any suspected ADR of a biosimilar even if the reaction is already listed in the reference medicine's SmPC.
Slovenian: Pomembno je, da zdravstveni delavci poročajo o vsakem domnevnem neželenem učinku podobnega biološkega zdravila, tudi če je učinek že naveden v povzetku glavnih značilnosti referenčnega zdravila.
English: When the active substance is a protein, both the biosimilar and the reference medicine must contain the same protein (i.e. amino acid sequence) and the same ‘3D' structure (folding of the protein).
Slovenian: Kadar je zdravilna učinkovina beljakovina, morata podobno biološko zdravilo in referenčno zdravilo vsebovati enako beljakovino (tj. zaporedje aminokislin) in imeti enako tridimenzionalno strukturo (zvitje beljakovine).
English: Amino acid sequence and folding are the main factors that determine biological activity, which must be the same for the biosimilar and the reference medicine.
Slovenian: Zaporedje aminokislin in zvitje sta glavna dejavnika, ki določata biološke aktivnosti in ki morata biti pri podobnem biološkem in referenčnem zdravilu enaka.
English: Minor change (e.g. adding a more sensitive test method to characterise the active substance)
Slovenian: Manjša sprememba (npr. dodatek občutljivejše testne metode za karakterizacijo zdravilne učinkovine)
English: When two medicines release the same active substance into the body at the same rate and to the same extent under similar conditions.
Slovenian: Kadar dve zdravili v podobnih razmerah enako hitro in v enakem obsegu sprostita enako zdravilno učinkovino v telo.
English: Extrapolation across different clinical settings
Slovenian: Ekstrapolacija med različnimi kliničnimi okolji
English: This is because immunogenicity is determined by more than product-related characteristics.
Slovenian: Imunogenosti namreč ne določajo le značilnosti, povezane z zdravilom.
English: Minor variability, e.g. in glycosylation (represented by small blue triangles) may be allowed, while the protein's amino acid sequence (circles) and biological activity are the same.
Slovenian: Dovoljena je lahko manjša variabilnost, npr. pri glikozilaciji (ki jo ponazarjajo majhni modri trikotniki), medtem ko sta zaporedje aminokislin (krogi) in biološka aktivnost enaka.
English: Accessed on 10 April 2017.
Slovenian: Dostop 10. aprila 2017.
English: Comparative clinical trials are specifically designed to rule out clinically relevant differences in safety or efficacy between the biosimilar and the reference medicine, and to confirm biosimilarity.
Slovenian: Primerjalna klinična preskušanja so posebej zasnovana za izključevanje klinično pomembnih razlik v varnosti ali učinkovitosti med podobnim biološkim in referenčnim zdravilom ter za potrditev biološke podobnosti.
English: Development aims at demonstrating comparable safety and efficacy by establishing biosimilarity
Slovenian: Cilj razvoja je dokazati primerljivo varnost in učinkovitost z ugotovitvijo biološke podobnosti
English: Monitoring long-term or long-latency adverse events
Slovenian: Spremljanje dolgoročnih neželenih dogodkov ali neželenih dogodkov z dolgo latenco
English: IMS Health, The impact of biosimilar competition, June 2016. http://ec.europa.eu/ growth/tools-databases/newsroom/cf/itemdetail.
Slovenian: IMS Health, The impact of biosimilar competition, junij 2016. http://ec.europa.eu/ growth/content/impact-biosimilar-competitionprice-volume-and-market-share-updatedversion-2016-0_en.
English: Immunogenicity data required for approval include incidence, titre and persistence of antibodies against the biological medicine (ADAs), neutralisation assays (because neutralising antibodies may reduce the effect of the medicine), assessment of the clinical impact and measures to manage the potential risk of immunogenicity (e.g. special monitoring of immune-mediated adverse reactions or use of concomitant medication to mitigate infusion reactions).
Slovenian: Podatki o imunogenosti, ki so potrebni za odobritev, vključujejo incidenco, titer in obstojnost protiteles proti biološkemu zdravilu (ADA), nevtralizacijske določitve (ker lahko nevtralizacijska protitelesa zmanjšajo učinek zdravila), oceno kliničnega učinka in ukrepe za obvladovanje morebitnega tveganja za pojav imunogenosti (npr. posebno spremljanje neželenih imunskih reakcij ali uporaba zdravil za sočasno zdravljenje za zmanjšanje reakcij ob infundiranju).
English: This degree of minor variability can be present within or between batches of the same biological medicine (figure 2), particularly when manufacturing processes are modified during the commercial life of the medicine (e.g. increasing production scale).
Slovenian: Ta manjša stopnja variabilnosti lahko obstaja znotraj posamezne serije zadevnega biološkega zdravila ali med serijami (slika 2), zlasti če se proizvodni postopki med obdobjem dajanja zdravila v promet spremenijo (npr. pri povečevanju obsega proizvodnje).
English: Summary
Slovenian: Povzetek
English: Accessed on 6 March 2017.
Slovenian: Dostop 6. marca 2017.
English: Contributors
Slovenian: Sodelujoči
English: For simpler molecules with well-established action (e.g. filgrastim) and where comparative quality data are solid, it may be sufficient to compare the effect of the biosimilar and reference medicine with PK and PD studies in healthy volunteers.
Slovenian: Za enostavnejše molekule z dobro znanim delovanjem (npr. filgrastim) in kadar so primerjalni podatki o kakovosti zanesljivi, lahko zadošča primerjava učinka podobnega biološkega zdravila in referenčnega zdravila, izvedena s študijami o farmakokinetiki in farmakodinamiki na zdravih prostovoljcih.
English: Trials designed mainly to show clinical equivalence with the reference medicine using sensitive endpoints in a population where product-related differences in clinical performance can be detected
Slovenian: Preskušanja, ki so zasnovana večinoma za dokazovanje klinične enakovrednosti z referenčnim zdravilom z uporabo občutljivih končnih točk v populaciji in s katerimi je mogoče odkriti z zdravilom povezane razlike v klinični učinkovitosti
English: Comprehensive physicochemical and functional in vitro studies
Slovenian: Obsežne fizikalno-kemijske študije in funkcionalne študije in vitro
English: Data from a given indication (e.g. rheumatoid arthritis) may not be directly applicable in terms of safety or efficacy to an indication falling within another therapeutic area where the mode of action, posology or pharmacokinetics may be different (e.g. oncology).
Slovenian: Podatki o določeni indikaciji (npr. revmatoidni artritis) z vidika varnosti in učinkovitosti morda niso uporabni neposredno za obravnavo indikacije, ki spada v drugo terapevtsko področje, kjer so lahko način delovanja, odmerjanje ali farmakokinetika drugačni (npr. v onkologiji).
English: If patients have questions on whether a particular biological medicine is a biosimilar, their healthcare professionals can find this information in section 5.1 of the SmPC.
Slovenian: Če imajo pacienti vprašanja o tem, ali je določeno biološko zdravilo podobno biološko zdravilo, lahko zdravstveni delavci poiščejo informacije v poglavju 5.1 povzetka glavnih značilnosti zdravila.
English: Companies can market approved biosimilars once the period of market protection of the reference medicine expires (after 10 years).
Slovenian: Poslovni subjekti lahko dajo v promet odobrena podobna biološka zdravila po izteku obdobja tržne zaščite referenčnega zdravila (po desetih letih).
English: An overview of biosimilar development compared with the development of reference medicines is provided in table 4.
Slovenian: Pregled razvoja podobnih bioloških zdravil v primerjavi z razvojem referenčnih zdravil je prikazan v preglednici 4.
English: Pharmacovigilance and Risk Assessment Committee (EMA's scientific committee formed by EU experts on safety of medicines)
Slovenian: Odbor za oceno tveganj na področju farmakovigilance - znanstveni odbor EMA, sestavljen iz strokovnjakov EU za varnost zdravil (angl. Pharmacovigilance and Risk Assessment Committee)
English: Development based on demonstration of bioequivalence (i.e. that the generic and the reference medicine release the active substance into the body at the same rate and to the same extent under similar conditions)
Slovenian: Razvoj, ki temelji na dokazovanju bioekvivalence (tj. da generično in referenčno zdravilo v podobnih razmerah enako hitro in v enakem obsegu sprostita v telo enako količino zdravilne učinkovine)
English: To compare the pharmacological effects, a sensitive endpoint that allows detection of product-specific differences should be chosen.
Slovenian: Za primerjavo farmakoloških učinkov je potrebno izbrati občutljivo končno točko, ki omogoča odkrivanje za zdravilo značilnih razlik.
English: Also, antibodies directed against the biological medicine (‘anti-drug antibodies' or ADAs) could neutralise the medicine's activity and reduce its efficacy.
Slovenian: Poleg tega lahko protitelesa, ki so usmerjena proti biološkemu zdravilu (tim. ADA), nevtralizirajo delovanje zdravila in zmanjšajo njegovo učinkovitost.
English: Comparative trials are designed to confirm biosimilarity and clinical performance
Slovenian: Primerjalna preskušanja so zasnovana za potrditev biološke podobnosti in klinične učinkovitosti
English: The biosimilar has physical, chemical and biological properties highly similar to the reference medicine's.
Slovenian: Podobno biološko zdravilo ima fizikalne, kemijske in biološke lastnosti, ki so zelo podobne lastnostim referenčnega zdravila.
English: Extrapolation needs to be supported by all the scientific evidence generated in comparability studies (quality, non-clinical and clinical).
Slovenian: Ekstrapolacija mora biti podprta z vsemi znanstveni dokazi, pridobljenimi v primerjalnih študijah (študije kakovosti ter klinične in neklinične študije).
English: When any extra measure is applied to the reference medicine (e.g. educational material), it should also be considered for the biosimilar.
Slovenian: Če se za referenčno zdravilo uporablja poseben ukrep (npr. izobraževalno gradivo), ga je potrebno obravnavati tudi za podobno biološko zdravilo.
English: Healthcare professionals should ensure that tradename and batch number are reported in case of suspected adverse drug reactions, according to local practice and national regulations.
Slovenian: Zdravstveni delavci morajo zagotoviti, da se v primeru poročanja domnevnih neželenih učinkov zdravila zaščiteno ime in številka serije navedeta v skladu z lokalno prakso in nacionalnimi predpisi.
English: Accessed on 14 March 2017.
Slovenian: Dostop 14. marca 2017.
English: Comparison of the biosimilar with the reference medicine involves extensive comparability studies to assess any possible impact on safety and efficacy.
Slovenian: Primerjava podobnega biološkega zdravila z referenčnim zdravilom vključuje obsežne primerjalne študije za oceno morebitnega vpliva na varnost in učinkovitost.
English: Biological medicines: overview
Slovenian: Biološka zdravila: pregled
English: Key considerations on potential immunogenicity of biological medicines
Slovenian: Ključni vidiki obravnave potencialne imunogenosti bioloških zdravil
English: In addition to the EU product information (SmPC, package labelling and package leaflet), the EPAR documents contain assessment reports on the scientific evaluation of the medicine at the time of approval and when major changes are introduced (e.g. when a new indication is added).
Slovenian: Dokumenti EPAR poleg informacij o zdravilu iz EU (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) vsebujejo tudi poročila o oceni zdravila na podlagi znanstvenega vrednotenja zdravila v postopku odobritve kot tudi ob uvedbi večjih sprememb (npr. kadar se doda nova indikacija).
English: Comprehensive physicochemical and in vitro functional studies complemented as needed by non-clinical and clinical studies
Slovenian: Obsežne fizikalno-kemijske študije in funkcionalne študije in vitro, po potrebi dopolnjene z nekliničnimi in kliničnimi študijami.
English: Extrapolation of data to other indications is always supported by scientific evidence generated in robust comparability studies (quality, non-clinical and clinical).
Slovenian: Ekstrapolacija podatkov na druge indikacije je vedno podprta z znanstveni dokazi, pridobljenimi z zanesljivimi primerjalnimi študijami (študije kakovosti, klinične in neklinične študije).
English: Extension of the efficacy and safety data from a therapeutic indication for which the biosimilar has been clinically tested to another therapeutic indication approved for the reference medicine.
Slovenian: Razširitev podatkov o učinkovitosti in varnosti s terapevtske indikacije, za katero je bilo podobno biološko zdravilo klinično preskušeno, na drugo terapevtsko indikacijo, odobreno za referenčno zdravilo.
English: Healthcare professionals should check that the biosimilar is authorised for the intended indication.
Slovenian: Zdravstveni delavci morajo preveriti, ali je podobno biološko zdravilo odobreno za zadevno indikacijo.
English: Comparability: a scientific principle routinely used after manufacturing changes to medicines on the market
Slovenian: Primerljivost: znanstveno načelo, ki se rutinsko uporablja ob spremembah proizvodnje zdravil, ki so že v prometu
English: Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the EU.
Slovenian: Podobna biološka zdravila so odobrena na podlagi enakih standardov farmacevtske kakovosti, varnosti in učinkovitosti, kot se uporabljajo za vsa biološka zdravila, odobrena v EU.
English: All indications of biological medicines (including biosimilars) have been granted based on sound scientific evidence.
Slovenian: Vse indikacije bioloških zdravil (vključno s podobnimi biološkimi zdravili) so bile odobrene na podlagi zanesljivih znanstvenih dokazov.
English: The EU SmPC includes information and recommendations to enable healthcare professionals to prescribe the medicine and to give advice to patients on its use.
Slovenian: Povzetek glavnih značilnosti zdravila v EU vključuje informacije in priporočila, na podlagi katerih lahko zdravstveni delavci predpišejo zdravilo in svetujejo pacientom o njegovi uporabi.