FrancophonIA/ELRC3.0 huggingface dataset:
English: The goal is to rule out potential product-related differences that could affect pharmacokinetics (PK), efficacy or safety, including immunogenicity.
Slovenian: cilj je izključiti morebitne z zdravilom povezane razlike, ki bi lahko vplivale na farmakokinetiko, učinkovitost ali varnost, vključno z imunogenostjo.
English: Microheterogeneity Minor molecular variability among biological substances due to natural biological variability and slight alterations to production methods.
Slovenian: Manjša molekularna variabilnost med biološkimi snovmi zaradi naravne biološke variabilnosti in manjših sprememb proizvodnih metod.
English: Centralised procedure Approval process of medicines which involves a single application, a single evaluation and, for successful applications, a single authorisation valid throughout the European Union.
Slovenian: Centralizirani postopek Postopek odobritve zdravil, ki vključuje eno vlogo, eno vrednotenje in za uspešne vloge eno dovoljenje za promet, ki velja po vsej Evropski uniji.
English: CHMP/437/04 Rev. 1. http://www.ema.europa.
Slovenian: CHMP/437/04 Rev. 1. http://www.ema.
English: Traceability: importance of identifying biological medicines by tradename and batch number
Slovenian: Sledljivost: pomen identifikacije bioloških zdravil z zaščitenim imenom in številko serije
English: Safety data are collected throughout the clinical development programme, including during PK and PD studies.
Slovenian: Podatki o varnosti se zbirajo skozi celoten program kliničnega razvoja, tudi med študijami o farmakokinetiki in farmakodinamiki.
English: Any decision on switching should involve the prescriber in consultation with the patient, and take into account any policies that the country might have regarding the prescribing and use of biological medicines.
Slovenian: Vsaka odločitev o preklopu bi morala vključevati predpisovalca zdravil in njegov posvet s pacientom, upoštevati pa bi bilo treba tudi politike, ki jih država izvaja v zvezi s predpisovanjem in uporabo bioloških zdravil.
English: The criteria for deciding whether a post-marketing safety study is needed are the same for all medicines, including biosimilars and their reference medicines.
Slovenian: Merila za odločitev o tem, ali je študija o varnosti zdravila po pridobitvi dovoljenja za promet potrebna, so enaka za vsa zdravila, vključno s podobnimi biološkimi zdravili in njihovimi referenčnimi zdravili.
English: Minor variability is only allowed when scientific evidence shows that it does not affect the safety and efficacy of the biosimilar.
Slovenian: Manjša variabilnost je dovoljena izključno, kadar znanstveni dokazi izkazujejo odsotnost njenega vpliva na varnost in učinkovitost podobnega biološkega zdravila.
English: Comparative quality studies Analytical: physical + chemical properties Functional: biological/pharmacological activity
Slovenian: Analitične: fizikalne + kemijske lastnosti Funkcionalne: biološka/farmakološka aktivnost
English: Biological medicines are made by living organisms, which are naturally variable.
Slovenian: Biološka zdravila proizvajajo živi organizmi, ki so že po svoji naravi spremenljivi.
English: Clinical trials are tailored to confirm biosimilarity and to address any questions that may remain from previous analytical or functional studies.
Slovenian: Klinična preskušanja so prilagojena potrjevanju biološke podobnosti in pojasnjevanju morebitnih vprašanj, ki so morda ostala odprta v prejšnjih analitičnih ali funkcionalnih študijah.
English: National regulatory authorities in the EU regularly inspect manufacturing sites for compliance with GMP requirements.
Slovenian: nacionalni regulativni organi v EU redno nadzorujejo proizvodne obrate glede skladnosti z zahtevami dobre proizvodne prakse;
English: In vivo toxicological studies are only required in certain cases, for example when the biosimilar is produced in a new type of cell or organism, or when the formulation includes new excipients not used previously.
Slovenian: Toksikološke študije in vivo se zahtevajo samo v nekaterih primerih, na primer če je podobno biološko zdravilo proizvedeno v novi vrsti celice ali organizma ali če farmacevtska oblika vključuje nove pomožne snovi, ki se predhodno še niso uporabljale.
English: Safety data can only be extrapolated after a comparable safety profile has been established for the biosimilar in one therapeutic indication.
Slovenian: Podatki o varnosti se lahko ekstrapolirajo šele po vzpostavitvi primerljivega varnostnega profila za podobno biološko zdravilo pri eni terapevtski indikaciji.
English: European Medicines Agency: Immunogenicity assessment of biotechnology-derived therapeutic proteins.
Slovenian: Evropska agencija za zdravila: Immunogenicity assessment of biotechnology-derived therapeutic proteins.
English: Additional monitoring encourages healthcare professionals and patients to report any suspected adverse drug reactions of new medicines.
Slovenian: Dodatno spremljanje varnosti spodbuja zdravstvene delavce in paciente, da poročajo o katerem koli domnevnem neželenem učinku novega zdravila.
English: Strict control of the quality of biological medicines
Slovenian: Strog nadzor kakovosti bioloških zdravil
English: The black triangle symbol identifies medicines under additional monitoring.
Slovenian: Črni trikotnik označuje zdravila, za katera se izvaja dodatno spremljanje varnosti.
English: The amino acid sequence (represented by circles) and biological activity of the protein remain the same in all batches, even when these minor differences in sugar chains are present.
Slovenian: Zaporedje aminokislin (ki so ponazorjene s krogi) in biološka aktivnost beljakovine ostaneta enaka v vseh serijah, kljub tovrstnim manjšim razlikam v verigah sladkorja.
English: For questions from patients on what is a biosimilar, and how its safety and efficacy are ensured, patients can consult a questions-and-answers document in patient-friendly language available on the European Commission's website.
Slovenian: Odgovore na vprašanja o tem, kaj je podobno biološko zdravilo ter kako sta zagotovljeni njegova varnost in učinkovitost, lahko pacienti najdejo v dokumentu z vprašanji in odgovori12, ki je v pacientom razumljivem jeziku na voljo na spletnih straneh Evropske komisije.
English: In many settings, these endpoints are more sensitive than clinical outcomes to detect potential differences between a biosimilar and the reference medicine.
Slovenian: V številnih primerih so te končne točke bolj občutljive kot klinični rezultati za odkrivanje morebitnih razlik med podobnim biološkim in referenčnim zdravilom.
English: Biosimilar medicines: definition and features
Slovenian: Podobna biološka zdravila: definicija in značilnosti
English: Why biosimilars are not considered generic medicines
Slovenian: Zakaj podobnih bioloških zdravil ne obravnavamo kot generična zdravila
English: Regulators have built up extensive experience to conclude that such differences do not affect the medicine's quality, safety and efficacy.
Slovenian: Regulativni organi so pridobili bogate izkušnje, na podlagi katerih lahko sklenejo, da take razlike ne vplivajo na kakovost, varnost in učinkovitost zdravila.
English: When a new medicine is approved by EMA, the Agency also publishes a summary for the general public explaining why the medicine is approved in the EU.
Slovenian: Kadar Evropska agencija za zdravila poda mnenje za odobritev novega zdravila, objavi tudi povzetek za širšo javnost s pojasnilom, na kakšni podlagi je zdravilo odobreno v EU.
English: Over the years, EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
Slovenian: V zadnjih letih je Evropska agencija za zdravila izdala znanstvene smernice za pomoč razvojnim poslovnim subjektom pri njihovem prilagajanju strogim regulativnim zahtevam za odobritev podobnih bioloških zdravil.
English: This is because of the intrinsic ability of proteins and other biological medicines to cause an unwanted immune response, which, in rare cases, could cause a serious adverse reaction (e.g. anaphylaxis or delayed hypersensitivity) or reduced efficacy.
Slovenian: Razlog za to je intrinzična sposobnost beljakovin in drugih bioloških zdravil, da povzročijo neželen imunski odziv, ki lahko v redkih primerih povzroči resne neželene učinke (npr. anafilaksijo ali zapoznelo preobčutljivost) ali manjšo učinkovitost.
English: The extent of the comparability studies required following a manufacturing change to a biological medicine will depend on the expected impact on quality, safety and efficacy of the medicine.
Slovenian: Obseg primerjalnih študij, ki se zahtevajo ob spremembi proizvodnje biološkega zdravila, je odvisen od pričakovanega vpliva na kakovost, varnost in učinkovitost zdravila.
English: Many biological medicines are intended for longterm management of chronic conditions, and therefore, over time the patient may receive biological medicines with slight differences.
Slovenian: Številna biološka zdravila so namenjena dolgotrajnemu zdravljenju kroničnih bolezni, zato lahko pacienti skozi daljši čas prejmejo nekoliko različna biološka zdravila.
English: Pharmacovigilance Activities to detect and assess adverse reactions and other effects of medicines in use.
Slovenian: Dejavnosti za odkrivanje in ocenjevanje neželenih in drugih učinkov zdravil v uporabi.
English: In general, it is expected that biosimilars will be introduced to the market at a lower price than their reference medicine.
Slovenian: V splošnem je mogoče pričakovati, da bodo podobna biološka zdravila dana v promet po ceni, ki je nižja od cene zadevnega referenčnega zdravila.
English: Replacement can be done by:
Slovenian: Zamenjevanje se lahko izvede s/z:
English: Companies applying for marketing authorisation in the EU must submit a risk management plan (RMP) for each new medicine, including biological medicines.
Slovenian: Poslovni subjekti, ki vložijo vlogo za dovoljenje za promet z zdravilom v EU, morajo za vsako novo zdravilo, vključno z biološkimi zdravili, predložiti načrt za obvladovanje tveganj.
English: Factors relating to patients (age, immune status), disease (comorbidities, concomitant treatments) or treatment-related factors (route of administration, length of exposure) also have to be considered.
Slovenian: Upoštevati je potrebno tudi dejavnike, povezane s pacienti (starost, imunski status), boleznijo (pridružene bolezni, sočasna zdravljenja) ali zdravljenjem (pot uporabe, trajanje izpostavljenosti).
English: Over 50 biosimilars have been approved through EMA for use in the EU as at April 2017.
Slovenian: Do aprila 2017 je bilo za uporabo v EU preko Evropske agencije za zdravila odobrenih več kot 50 podobnih bioloških zdravil.
English: Safety studies after marketing
Slovenian: Študije o varnosti po prihodu zdravila v promet
English: However, confirmatory clinical trials with the biosimilar are usually not needed in every indication that has been approved for the reference medicine.
Slovenian: Vendar potrditvena klinična preskušanja podobnega biološkega zdravila običajno niso potrebna za vsako indikacijo, ki je bila potrjena za referenčno zdravilo.
English: Anti-drug antibody Antibodies produced by the body's immune system against an active substance (particularly a large molecule, such as a protein).
Slovenian: Protitelesa, ki jih proizvaja imunski sistem telesa proti zdravilni učinkovini (zlasti veliki molekuli kot je beljakovina).
English: Post-marketing studies allow monitoring of known risks and also permit detection of rare adverse drug reactions that emerge only when large numbers of patients have been treated for a long period.
Slovenian: Študije, ki se izvedejo po prihodu zdravila v promet omogočajo spremljanje znanih tveganj, poleg tega pa omogočajo odkrivanje redkih neželenih učinkov zdravila, ki se pojavijo samo pri zdravljenju velikega števila pacientov skozi daljše obdobje.
English: European Medicines Agency: Similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues.
Slovenian: Evropska agencija za zdravila: Similar biological medicinal products containing biotechnologyderived proteins as active substance: nonclinical and clinical issues.
English: If comparability is shown at structural, functional, pharmacokinetic and pharmacodynamic level, and efficacy is comparable, then adverse reactions due to the biosimilar's pharmacological action can be expected to be the same and to occur at similar frequencies.
Slovenian: Če je primerljivost dokazana na strukturni, funkcionalni, farmakokinetični in farmakodinamični ravni ter je učinkovitost primerljiva, je mogoče pričakovati, da bodo neželeni učinki zaradi farmakološkega delovanja podobnega biološkega zdravila enaki in podobno pogosti.
English: All indications approved for the reference medicine can be granted based on demonstrated bioequivalence, without the need for further clinical data
Slovenian: Vse indikacije, odobrene za referenčno zdravilo, se lahko odobrijo na podlagi dokazane bioekvivalence, pri čemer dodatni klinični podatki niso potrebni
English: Adverse reactions of an immune nature (e.g. infusion-related reactions or injection-site reactions) are normally not severe.
Slovenian: Neželene imunske reakcije (npr. reakcije, povezane z infundiranjem ali reakcije na mestu injiciranja) običajno niso hude.
English: Thus, the active substance in the final biological medicine can have an inherent degree of minor variability
Slovenian: Zato lahko zdravilna učinkovina v končnem biološkem zdravilu izraža določeno manjšo stopnjo variabilnosti
English: Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Slovenian: Nekatera podobna biološka zdravila se lahko odobrijo na nacionalni ravni, na primer nekateri heparini z majhno molekulsko maso, pridobljeni iz prašičje črevesne sluznice.
English: Approval of biosimilars builds on existing scientific knowledge on safety and efficacy of the reference medicine gained during its clinical use, so fewer clinical data are needed.
Slovenian: Odobritev podobnih bioloških zdravil temelji na obstoječih znanstvenih spoznanjih o varnosti in učinkovitosti referenčnega zdravila, pridobljenih med njegovo klinično uporabo, zato je potrebnih manj kliničnih podatkov.
English: Comparability
Slovenian: Primerljivost
English: Such studies look both at short-term immune responses (e.g. infusion-related reactions), as well as long-term (e.g. delayed responses due to an evolving immune reaction).
Slovenian: S takšnimi študijami se proučujejo kratkotrajni imunski odzivi (npr. reakcije, povezane z infundiranjem), pa tudi dolgotrajni (npr. zapozneli odzivi zaradi postopnega razvoja imunske reakcije).
English: Most of the widely used biological medicines on the market have seen several changes to their manufacturing process and these often result in minor differences from the version initially approved or the version used in the clinical trials filed for approval.
Slovenian: Pri večini bioloških zdravil na trgu, ki se široko uporabljajo, se je postopek proizvodnje že večkrat spremenil, kar je pogosto povzročilo manjše razlike v primerjavi z zdravilom, ki je bilo prvotno odobreno, ali zdravilom, ki je bilo uporabljeno v kliničnih preskušanjih, izvedenih za odobritev zdravila.
English: In most of these cases, clinical trials are not repeated for all indications and changes are approved based on quality and in vitro comparability studies.
Slovenian: V večini takih primerov se klinična preskušanja ne ponovijo za vse indikacije, spremembe pa se odobrijo na podlagi študij kakovosti in primerjalnih študij in vitro.
English: If a signal is suspected, it is evaluated by EMA's scientific committees, which will determine if any action is needed.
Slovenian: V primeru suma takšen signal ocenijo znanstveni odbori Evropske agencije za zdravila, ki določijo, ali so potrebni kakršni koli ukrepi.
English: These minor differences are not clinically meaningful, i.e. no differences are expected in safety and efficacy.
Slovenian: Te manjše razlike niso klinično pomembne, kar pomeni, da ni pričakovati razlik v varnosti in učinkovitosti.
English: The principles of selecting equivalence margins are not unique to biosimilar testing: they are routinely used in clinical trials when comparing treatment alternatives, or when comparing the same medicine before and after manufacturing changes that may have a clinical effect
Slovenian: Načela izbiranja robnih vrednosti intervalov ekvivalence niso omejena na preskušanje podobnih bioloških zdravil: redno se uporabljajo pri kliničnih preskušanjih, kadar se primerjajo terapevtske alternative ali kadar se isto zdravilo primerja pred in po spremembah proizvodnje, ki imajo lahko klinični učinek3.
English: Healthcare professionals should contact their national medicines regulatory authorities for advice on how to report adverse drug reactions.
Slovenian: Zdravstveni delavci se morajo posvetovati z nacionalnimi regulativnimi organi za zdravila o načinu poročanja o neželenih učinkih zdravil.
English: The approach is equivalent to when major changes are introduced to the manufacturing process for a medicine made by biotechnology (scenario 3 in table 5).
Slovenian: Pristop je enakovreden pristopu, ki se uporablja, kadar se v postopek proizvodnje zdravila, ki se proizvaja z uporabo biotehnologije (scenarij 3 v preglednici 5), uvedejo večje spremembe.
English: No differences are expected in clinical performance.
Slovenian: Razlik v doseganju kliničnih izidov ne pričakujemo.
English: Thus, these differences are not clinically meaningful in terms of safety or efficacy.
Slovenian: Tovrstne razlike zato niso klinično pomembne v smislu varnosti ali učinkovitosti.
English: Positive benefit-risk based on demonstrating biosimilarity (using comparability studies)
Slovenian: Pozitivno razmerje med koristmi in tveganji, ki temelji na dokazovanju biološke podobnosti (z uporabo primerjalnih študij)
English: Comprehensive comparability studies with the reference medicine
Slovenian: Celovite primerjalne študije z referenčnim zdravilom
English: Due to the natural variability of the biological source and to the manufacturing process unique to each manufacturer, minor differences can occur between the biosimilar and its reference medicine (table 1 and figure 3).
Slovenian: Zaradi naravne variabilnosti biološkega vira in proizvodnega postopka, značilnega za vsakega proizvajalca, se lahko pojavijo manjše razlike med podobnim biološkim zdravilom in njegovim referenčnim zdravilom (preglednica 1 in slika 3).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.
Slovenian: Podrobne informacije so objavljene na spletnih straneh Evropske agencije za zdravila http://www.ema.europa.eu.
English: Biosimilar competition can offer advantages to EU healthcare systems, as it is expected to improve patients' access to safe and effective biological medicines with proven quality.
Slovenian: Konkurenčnost podobnih bioloških zdravil lahko prinese ugodnosti za zdravstvene sisteme v EU, saj pričakovano izboljša dostop pacientov do varnih in učinkovitih bioloških zdravil z dokazano kakovostjo.
English: Extrapolation of immunogenicity data
Slovenian: Ekstrapolacija podatkov o imunogenosti
English: Their assessment reports can be accessed on EMA's website, on the landing page of each medicine, under the tab ‘assessment history'.
Slovenian: Njihova poročila o oceni so na voljo na spletnih straneh agencije, in sicer na ciljni strani posameznega zdravila pod zavihkom „Assessment history “ (»Zgodovina ocenjevanja«).
English: This is achieved with a robust manufacturing process to ensure that all batches of the medicine are of proven quality.
Slovenian: Doseže se z zanesljivim proizvodnim postopkom, ki zagotavlja, da imajo vse serije zdravila dokazano kakovost.
English: Prescribers can have confidence in using biological medicines (including biosimilars) for all their approved indications, as all approved indications of a medicine are granted based on scientific evidence.
Slovenian: Predpisovalci lahko zaupajo uporabi bioloških zdravil (vključno s podobnimi biološkimi zdravili) za vse njihove odobrene indikacije, saj so vse odobrene indikacije zdravila določene na podlagi znanstvenih dokazov.
English: The RMP, which is tailored for each product, includes a pharmacovigilance plan and risk minimisation measures to identify, characterise and minimise a medicine's important risks.
Slovenian: Le-ta je prilagojen vsakemu posameznemu zdravilu in vključuje farmakovigilančni načrt ter ukrepe za zmanjšanje tveganj, kjer se identificirajo, opišejo in zmanjšajo pomembna tveganja, povezana z zdravilom.
English: EU manufacturers must hold a manufacturer's license and are legally obliged to comply with Good Manufacturing Practice (GMP), the agreed standards to obtain a medicine with proven quality.
Slovenian: proizvajalci v EU morajo imeti dovoljenje za proizvodnjo in so po zakonu dolžni spoštovati dobro proizvodno prakso, tj. uveljavljene standarde za izdelavo zdravila dokazane kakovosti;
English: Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine.
Slovenian: Varnost podobnih bioloških zdravil se spremlja s farmakovigilančnimi aktivnostmi enako kot za vsa druga zdravila.
English: Reference medicine A biological medicine approved in the EU, which is chosen by a company developing a biosimilar as a reference for the head-to-head comparison of quality, safety and efficacy.
Slovenian: Referenčno zdravilo Biološko zdravilo, odobreno v EU, ki ga poslovni subjekt, ki razvija podobno biološko zdravilo, izbere kot referenčno za neposredno primerjavo kakovosti, varnosti in učinkovitosti.
English: For any biological medicine with a new active substance, a positive benefit-risk balance is determined mainly from evidence of safety and efficacy in pivotal trials in humans (figure 4), supported by solid pharmaceutical quality data and non-clinical data.
Slovenian: Za vsako biološko zdravilo z novo zdravilno učinkovino se pozitivno razmerje med koristjo in tveganjem ugotovi večinoma na podlagi dokazov o varnosti in učinkovitosti, pridobljenih s ključnimi kliničnimi preskušanji na ljudeh (slika 4), ki so podprti z zanesljivimi podatki o farmacevtski kakovosti in z nekliničnimi podatki.
English: Consequently, more studies are needed for regulatory approval of biosimilars than for generics to ensure that minor differences do not affect safety or efficacy.
Slovenian: Za regulatorno odobritev podobnih bioloških zdravil je zato potrebnih več študij kot za generična zdravila, da bi se zagotovilo, da manjše razlike ne bodo vplivale na varnost ali učinkovitost.
English: Data on biosimilarity: published in the assessment report
Slovenian: Podatki o biološki podobnosti: objavljeni v poročilu o oceni zdravila
English: In most of these cases, regulators approve manufacturing changes based on comparability studies and clinical trials are not repeated for all indications.
Slovenian: V večini takih primerov regulativni organi odobrijo spremembe proizvodnje na podlagi primerjalnih študij, klinična preskušanja pa se ne ponovijo za vse indikacije.
English: structural characterisation and other physicochemical properties purity (traces of residues from the manufacturing process have to be controlled and must not exceed acceptable levels)
Slovenian: čistoti (sledi nečistot iz proizvodnega postopka je treba nadzorovati in ne smejo presegati sprejemljivih ravni);
English: Periodic safety update report
Slovenian: Redno posodobljeno poročilo o varnosti zdravila
English: Since the introduction of the first biosimilar in clinical use in 2006, an increasing number of biosimilars have been approved and safely used in the EU.
Slovenian: Od uvedbe prvega podobnega biološkega zdravila v klinično uporabo leta 2006 je bilo v EU odobrenih in se varno uporablja vse več podobnih bioloških zdravil.
English: Adverse drug reaction An unwanted medical event following the use of a medicine.
Slovenian: Neželeni z zdravljenjem povezan dogodek po uporabi zdravila.