FrancophonIA/ELRC3.0 huggingface dataset:
English: This is particularly important to learn of rare immune reactions that can only be detected after a long follow-up period in larger numbers of patients.
Slovenian: To je pomembno predvsem zato, da se ugotovijo redke imunske reakcije, ki se lahko odkrijejo šele po daljšem obdobju spremljanja večjega števila pacientov.
English: The review by EMA results in a scientific opinion, which is then sent to the European Commission, which ultimately grants an EU-wide marketing authorisation.
Slovenian: Rezultat ovrednotenja Evropske agencije za zdravila je znanstveno mnenje, ki se nato pošlje Evropski komisiji, ki na koncu izda dovoljenje za promet, veljavno v celotni EU.
English: However, detecting and characterising the longterm adverse drug reactions of biological medicines may be difficult using only spontaneous reporting.
Slovenian: Vendar sta odkrivanje in opredelitev dolgoročnih neželenih učinkov bioloških zdravil lahko težavna, če se zanje uporablja samo spontano poročanje.
English: Thus, potential immunogenicity needs to be always evaluated for all biological medicines.
Slovenian: Zato je treba potencialno imunogenost vedno ovrednotiti za vsa biološka zdravila.
English: This scientific principle is routinely used when a change is introduced to the manufacturing process of medicines made by biotechnology, to ensure that the change does not alter safety and efficacy.
Slovenian: To znanstveno načelo se sistematično uporablja ob uvedbi spremembe postopka proizvodnje zdravil, ki se proizvajajo z uporabo biotehnologije, za zagotovitev, da sprememba ne vpliva na varnost in učinkovitost.
English: ADAs against a medicine can result in loss of efficacy or in immunological reactions.
Slovenian: Protitelesa proti zdravilu lahko povzročijo izgubo učinkovitosti ali pojav imunskih reakcij.
English: Comparability studies only for manufacturing changes during development (e.g. producing larger batches for clinical trials)
Slovenian: Primerjalne študije samo za spremembe proizvodnje med razvojem (npr. proizvodnja večjih serij za klinična preskušanja)
English: The requirements for biosimilar approval in the US by the FDA are based on the same scientific rationale as in the EU, although specific data requirements may differ between these two regions due to different legal frameworks.
Slovenian: Zahteve ameriške Uprave za hrano in zdravila za odobritev podobnih bioloških zdravil temeljijo na enaki znanstveni podlagi kot v EU, čeprav se lahko določene zahteve po podatkih med tema dvema regijama zaradi različnih pravnih okvirov razlikujejo.
English: Several national regulatory authorities also provide information on biosimilars in their local language.
Slovenian: Posamezni nacionalni pristojni organi informacije o podobnih bioloških zdravilih zagotavljajo tudi v svojem nacionalnem jeziku.
English: For all medicines approved in the EU, in addition to the conditions of use in the product information, additional measures (e.g. educational brochures, patient alert cards or inclusion of patients in registries) may be needed to manage a specific risk.
Slovenian: Za vsa zdravila, odobrena v EU, so poleg pogojev uporabe, podanih v informacijah o zdravilu, lahko potrebni tudi dodatni ukrepi (npr. izobraževalne brošure, kartice z opozorili za paciente ali vključitev pacientov v registre) za obvladovanje posebnega tveganja.
English: Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety.
Slovenian: Danes so podobna biološka zdravila sestavni del učinkovitih bioloških terapij, ki so na voljo v EU in so podprta z ustreznimi zaščitnimi ukrepi za varnost pacientov.
English: Studies of the biochemical and physiological effects of a medicine in the body, including mechanism of action.
Slovenian: Študije biokemičnih in fizioloških učinkov zdravila v telesu, vključno z mehanizmom delovanja.
English: Approval of medicines in the EU relies on a solid legal framework, which in 2004 introduced a dedicated route for the approval of biosimilars.
Slovenian: Odobritev zdravil v EU temelji na trdnem pravnem okviru, s katerim je bil leta 2004 uveden poseben postopek odobritve podobnih bioloških zdravil.
English: Authorities continuously evaluate the benefit-risk balance of all medicines and take necessary regulatory action (e.g. introducing new warnings in the product information or restricting use) to safeguard public health.
Slovenian: Pristojni organi nenehno ocenjujejo razmerje med koristmi in tveganji vseh zdravil ter sprejemajo regulativne ukrepe (npr. uvajajo nova opozorila v informacije o zdravilu ali omejujejo uporabo), potrebne za zaščito javnega zdravja.
English: Extrapolation of data to other indications is always supported by robust physicochemical and in vitro studies to assess all the possible mechanisms of action.
Slovenian: Ekstrapolacija podatkov na druge indikacije je vedno podprta z zanesljivimi fizikalno-kemijskimi študijami in študijami in vitro, da se ocenijo vsi možni mehanizmi delovanja.
English: The list of INNs, which is globally recognised and public property, is maintained by WHO.
Slovenian: Seznam mednarodnih nelastniških imen, ki je svetovno prepoznan in je javno dobro, vzdržuje SZO.
English: These include information on analytical and functional comparability, pharmacokinetics, clinical comparability and immunogenicity.
Slovenian: Ta poročila vključujejo informacije o analitični in funkcionalni primerljivosti, farmakokinetiki, klinični primerljivosti in imunogenosti.
English: For biological medicines, some of the GMP requirements have been adapted to take into account their specific nature (e.g. use of appropriate aseptic techniques, refrigeration and other storage conditions, stability, transport etc.).
Slovenian: Za biološka zdravila so bile nekatere zahteve dobre proizvodne prakse prilagojene z namenom, da bi se upoštevale njihove posebne značilnosti (npr. uporaba ustreznih aseptičnih tehnik, hlajenje oz. zamrzovanje in drugi pogoji shranjevanja, stabilnost, prevoz itd.).
English: Adalimumab Infliximab Rituximab Bevacizumab Trastuzumab
Slovenian: beljakovine monoklonska protitelesa adalimumab infliksimab rituksimab bevacizumab trastuzumab
English: For biological medicines, this includes studying their specific physicochemical properties, biological activity, purity, sterility and stability to ensure that all the required standards are met before batches are released for marketing.
Slovenian: Za biološka zdravila to vključuje proučevanje njihovih posebnih fizikalno-kemijskih lastnosti, biološke aktivnosti, čistote, sterilnosti in stabilnosti, z namenom zagotovitve, da so pred sprostitvijo serij zdravila v promet izpolnjeni vsi zahtevani standardi.
English: In this case, additional studies (nonclinical or clinical) will be needed to prove that the biosimilar and reference medicine will behave similarly in the extrapolated indication.
Slovenian: V tem primeru so potrebne dodatne študije (neklinične ali klinične) zato, da se dokaže, da se bosta podobno biološko in referenčno zdravilo pri ekstrapolirani indikaciji obnesla podobno.
English: This means that patients and healthy volunteers will not be subjected to unnecessary clinical trials.
Slovenian: To pomeni, da se na pacientih in zdravih prostovoljcih ne bodo izvajala nepotrebna klinična preskušanja.
English: Information on the scientific evaluation performed by EMA's scientific committees is available on EMA's website and could be used to support decisions.
Slovenian: Informacije o znanstveni oceni zdravila, ki so jo izdelali znanstveni odbori Evropske agencije za zdravila, so na voljo na spletnih straneh Agencije in se lahko uporabijo za podporo odločitvam.
English: Same pharmaceutical quality standards for all medicines
Slovenian: Enaki standardi farmacevtske kakovosti za vsa zdravila
English: Interchangeability, switching and substitution: EMA and Member States' responsibilities
Slovenian: Medsebojna zamenljivost, preklop in lekarniško nadomeščanje: odgovornosti Evropske agencije za zdravila in držav članic EU
English: These studies are much more sensitive than clinical trials for detecting such differences, as there is often variability among human subjects participating in trials.
Slovenian: Te študije so v primerjavi s kliničnimi preskušanji veliko bolj občutljive za odkrivanje tovrstnih razlik, saj je med ljudmi, ki sodelujejo v preskušanjih, pogosto prisotna variabilnost.
English: European Medicines Agency: Similar biological medicinal products (overarching guideline).
Slovenian: Evropska agencija za zdravila: Similar biological medicinal products (overarching guideline).
English: This can be accepted if all the scientific evidence available from the comparability studies establishes biosimilarity and can address the specific aspects of the ‘extrapolated' indication (e.g. mode of action, potentially unique safety or immunogenicity aspects).
Slovenian: To je sprejemljivo, če vsi znanstveni dokazi, pridobljeni v primerjalnih študijah, dokazujejo biološko podobnost in lahko pojasnjujejo posamezne vidike „esktrapolirane“ indikacije (npr. način delovanja, morebitne specifične vidike varnosti ali imunogenosti).
English: It is mandatory for certain types of medicines, including all medicines produced by biotechnology and medicines for specific conditions such as cancer, neurodegeneration and autoimmune diseases.
Slovenian: Obvezen je za nekatere vrste zdravil, vključno z vsemi zdravili, proizvedenimi z uporabo biotehnologije, in zdravili za določene bolezni, kot so rak, nevrodegenerativne in avtoimunske bolezni.
English: This is why at the time of approval regulators may impose on the company an obligation to carry out a postauthorisation safety study (PASS).
Slovenian: Zato lahko regulativni organi ob odobritvi zdravila imetniku dovoljenja za promet naložijo obveznost izvedbe študije o varnosti zdravila po pridobitvi dovoljenja za promet (PASS).
English: The potential effect of these changes on the biological medicine's clinical performance is carefully evaluated with comparability studies (mainly quality and in vitro studies).
Slovenian: Morebitni vpliv teh sprememb na klinično učinkovitost biološkega zdravila se skrbno oceni s primerjalnimi študijami (večinoma študijami kakovosti in študijami in vitro).
English: Recombinant DNA technology
Slovenian: Tehnologija rekombinantne DNK
English: Comparability studies needed following changes to the manufacturing process of a medicine produced by biotechnology
Slovenian: Primerjalne študije, potrebne po spremembah postopka proizvodnje zdravila, ki se proizvaja z uporabo biotehnologije
English: May affect product characteristics or specifications but not expected to affect safety or efficacy
Slovenian: Lahko vpliva na lastnosti ali specifikacije zdravila, vendar ne pričakujemo vpliva na varnost in učinkovitost
English: Biological medicines are well established in clinical practice and in many cases they are indispensable for the treatment of serious and chronic conditions such as diabetes, autoimmune diseases and cancers.
Slovenian: V klinični praksi so dobro uveljavljena in so v številnih primerih nepogrešljiva za zdravljenje hudih in kroničnih bolezni, kot so sladkorna bolezen, avtoimunske bolezni in rak.
English: EMA continues to share the extensive experience gained in the EU on biosimilars with other regulators around the world and participates in a number of international forums such as the International Pharmaceutical Regulators Forum.
Slovenian: Evropska agencija za zdravila še naprej izmenjuje bogate izkušnje o podobnih bioloških zdravilih, pridobljene v EU, z drugimi regulativnimi organi po svetu in sodeluje v številnih mednarodnih forumih kakršen je npr. je Mednarodni forum regulativnih organov na področju zdravil (IPRF).
English: The World Health Organization (WHO) has developed its own guidelines for biosimilars (called ‘similar biotherapeutic products' or SBPs) and biosimilar monoclonal antibodies, with the aim of providing guidance to regulatory agencies worldwide.
Slovenian: Svetovna zdravstvena organizacija (SZO) je pripravila lastne smernice za podobna biološka zdravila (imenovana „podobna bioterapevtska zdravila“ oziroma „SBP“) in podobna biološka monoklonska protitelesa, da bi zagotovila smernice za regulativne agencije po vsem svetu.
English: These summaries (called ‘EPAR summaries'), are available on each medicine's landing page on EMA's website in the form of questions-andanswers documents in all official EU languages.
Slovenian: Ti povzetki (imenovani povzetki „EPAR“) so na voljo na ciljni strani vsakega zdravila na spletnih straneh Evropske agencije za zdravila v obliki dokumentov z vprašanji in odgovori v vseh uradnih jezikih EU.
English: Rarely, however, an immune reaction against a biological medicine could be serious and life-threatening.
Slovenian: V redkih primerih pa je lahko imunska reakcija na biološko zdravilo tudi resna in smrtno nevarna.
English: Positive benefit-risk mainly established on the basis of safety and efficacy studies in the intended population
Slovenian: Pozitivno razmerje med koristmi in tveganji, ugotovljeno v prvi vrsti na podlagi študij varnosti in učinkovitosti v ciljni populaciji
English: EU contribution to the regulation of biosimilars worldwide
Slovenian: Prispevek EU k regulaciji podobnih bioloških zdravil na svetovni ravni
English: All medicines produced using biotechnology and those for specific indications (e.g. for cancer, neurodegeneration and auto-immune diseases) must be approved in the EU through EMA (via the so-called ‘centralised procedure').
Slovenian: Vsa zdravila, izdelana z uporabo biotehnologije, in tista za posebne indikacije (npr. za zdravljenje raka, nevrodegenerativnih in avtoimunskih bolezni) se morajo v EU odobriti preko Evropske agencije za zdravila (s tako imenovanim „centraliziranim postopkom“).
English: This could mean replacing a reference product with a biosimilar (or vice versa) or replacing one biosimilar with another.
Slovenian: To bi lahko pomenilo zamenjavo referenčnega zdravila s podobnim biološkim zdravilom (ali obratno) ali zamenjavo enega podobnega biološkega zdravila z drugim.
English: The package leaflet, which contains key recommendations for patients on how to use the medicine properly, does not include mention of biosimilarity, as this only refers to the medicine's development route and is not related to the use of the medicine.
Slovenian: Navodilo za uporabo, ki vsebuje ključna priporočila za paciente o pravilni uporabi zdravila, ne vključuje informacij o biološki podobnosti, saj se ta informacija nanaša na razvoj zdravila in ni povezana z uporabo zdravila.
English: Trials designed mainly to compare with placebo or current standard of therapy using ‘hard' endpoints (e.g. long-term outcome, mortality, structural damage) and a relevant patient population to demonstrate benefit
Slovenian: Preskušanja, zasnovana predvsem za primerjavo s placebom ali z veljavnim standardom zdravljenja z uporabo dobro definiranih končnih točk (npr. dolgoročni izid, smrtnost, strukturna poškodba) in ustrezne populacije pacientov za dokazovanje koristi
English: The quality of all medicines (biological and nonbiological) approved in the EU is rigorously proven.
Slovenian: Kakovost vseh zdravil (bioloških in nebioloških), ki so odobrena v EU, se dokazuje s strogim preverjanem.
English: International nonproprietary name, a unique name that identifies active substances.
Slovenian: Mednarodno nelastniško ime je enoznačno ime, ki opredeljuje zdravilno učinkovino.
English: Companies developing medicines in the EU, including biosimilars, must demonstrate with a large body of data that the medicine is manufactured to agreed standards and that it is suitable for its intended clinical use (what is known as ‘pharmaceutical quality').
Slovenian: Poslovni subjekti, ki razvijajo zdravila v EU, vključno z podobnimi biološkimi zdravili, morajo dokazati z veliko količino podatkov, da zdravilo proizvajajo v skladu z dogovorjenimi standardi in da je primerno za predvideno klinično uporabo (kar je znano kot „farmacevtska kakovost“).
English: This ensures that, in line with EU requirements for ADR reporting, the medicine can be correctly identified if any product-specific safety (or immunogenicity) concern arises.
Slovenian: To zagotavlja, da se lahko zdravilo v skladu z zahtevami EU za poročanje o neželenih učinkih zdravila pravilno identificira, če se v zvezi z zdravilom pojavijo kakršni koli pomisleki glede varnosti (ali imunogenosti).
English: These can differ in size and structural complexity, from simple proteins like insulin or growth hormone to more complex ones such as coagulation factors or monoclonal antibodies (figure 1).
Slovenian: Te se lahko razlikujejo po svoji velikosti in strukturni kompleksnosti ter segajo od enostavnih beljakovin, kot sta inzulin in rastni hormon, do bolj kompleksnih, kot so koagulacijski faktorji ali monoklonska protitelesa (slika 1).
English: If the mode of action of the active substance is complex and involves multiple receptors or binding sites (as is often the case with monoclonal antibodies), it may be difficult to establish the contribution of each receptor or binding site to each indication.
Slovenian: Če je način delovanja zdravilne učinkovine zapleten in vključuje več vrst receptorjev ali vezavnih mest (kot je pogosto pri monoklonskih protitelesih), je včasih težko določiti prispevek posameznega receptorja ali vezavnega mesta k posamezni indikaciji.
English: Inherent degree of variability
Slovenian: Prisotna stopnja variabilnosti
English: For each medicine approved through EMA, including biosimilars, EMA publishes a group of documents known as the european public assessment report (‘EPAR').
Slovenian: Za vsako zdravilo, ki je odobreno preko Evropske agencije za zdravila, vključno s podobnimi biološkimi zdravili, agencija objavi nabor dokumentov, ki so znani kot Evropsko javno poročilo o oceni zdravila („EPAR“).
English: For identifying and tracing biological medicines in the EU, medicines have to be distinguished by the tradename and batch number and this is particularly important in cases where more than one medicine with the same INN exists on the market.
Slovenian: Za identifikacijo in sledljivost bioloških zdravil v EU se morajo le-ta razlikovati po zaščitenem imenu in številki serije, kar je še posebno pomembno v primerih, kadar je v prometu prisotnih več zdravil z enakim INN.
English: Deoxyribonucleic acid
Slovenian: Deoksiribonukleinska kislina (angl. Deoxyribonucleic acid)
English: Foreword Summary Biological medicines: overview Key features of biological medicines Biosimilar medicines: definition and features Why biosimilars are not considered generic medicines Development and approval of biosimilars in the EU A robust regulatory framework for biosimilars Process for approval of biosimilars in the EU Data requirements for approval: a scientifically tailored package Immunogenicity Extrapolation Safety of biosimilars General considerations on safety for biosimilars Safety monitoring for all biological medicines, including biosimilars Traceability: importance of identifying biological medicines by tradename and batch number How healthcare professionals can help improve pharmacovigilance for biological medicines: Data included in the prescribing information and EMA assessment reports for biosimilars 27 Data for prescribing: summary of product characteristics (SmPC) Data on biosimilarity: published in the assessment report Implications of the availability of biosimilars Interchangeability, switching and substitution: EMA and Member States' responsibilities Definitions EMA and Member States' responsibilities Communicating with patients on biosimilars EU contribution to the regulation of biosimilars worldwide References Abbreviations Glossary
Slovenian: Uvodna beseda Povzetek Biološka zdravila: pregled Ključne značilnosti bioloških zdravil Podobna biološka zdravila: definicija in značilnosti Zakaj podobnih bioloških zdravil ne obravnavamo kot generična zdravila Razvoj in odobritev podobnih bioloških zdravil v EU Trden regulativni okvir za biološko podobna zdravila Proces odobritve podobnih bioloških zdravil v EU Zahtevani podatki za odobritev: znanstveno prilagojeni nabor Imunogenost Ekstrapolacija Varnost podobnih bioloških zdravil Splošni vidiki glede varnosti podobnih bioloških zdravil Spremljanje varnosti vseh bioloških zdravil, vključno s podobnimi biološkimi zdravili Sledljivost: pomen identifikacije bioloških zdravil z zaščitenim imenom in številko serije Kako lahko zdravstveni delavci pomagajo izboljšati farmakovigilanco bioloških zdravil Podatki, vključeni v informacije za predpisovanje zdravila in poročila Evropske agencije za zdravila o oceni podobnega biološkega zdravila Podatki za predpisovanje zdravila: povzetek glavnih značilnosti zdravila Podatki o biološki podobnosti: objavljeni v poročilu o oceni zdravila Pomen razpoložljivosti podobnih bioloških zdravil Medsebojna zamenljivost, preklop in lekarniško nadomeščanje: odgovornosti Evropske agencije za zdravila in držav članic EU Definicije Pristojnosti Evropske agencije za zdravila in držav članic EU Komuniciranje s pacienti o podobnih bioloških zdravilih Prispevek EU k regulaciji podobnih bioloških zdravil na svetovni ravni Viri Kratice Slovar
English: Comparative clinical trials to exclude clinically meaningful differences
Slovenian: Primerjalna klinična preskušanja za izključitev klinično pomembnih razlik
English: There is no specific safety requirement applicable only to biosimilars because of their different development route.
Slovenian: Ne obstajajo posebne varnostne zahteve, ki bi veljale samo za podobna biološka zdravila zaradi njihovih drugačnih poti razvoja.
English: Comparability is a well-established scientific principle of regulatory science: comprehensive comparative quality studies prove that physicochemical properties and biological activity are highly similar.
Slovenian: Primerljivost je dobro uveljavljeno znanstveno načelo v regulativni znanosti: s celovitimi primerjalnimi študijami kakovosti dokazujemo, da so fizikalno-kemijske lastnosti in biološka aktivnost visoko podobne.
English: Harmful immunogenicity is unlikely after manufacturing changes or after switching
Slovenian: Škodljiva imunogenost je po spremembah proizvodnje ali po preklopu malo verjetna
English: Conventional clinical trials to demonstrate efficacy and safety in all claimed therapeutic indications
Slovenian: Uveljavljene oblike kliničnih preskušanj z namenom dokazovanja učinkovitosti in varnosti pri vseh navedenih terapevtskih indikacijah
English: European Medicines Agency: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
Slovenian: Evropska agencija za zdravila: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
English: “This medicinal product is subject to additional monitoring”
Slovenian: „Za to zdravilo se izvaja dodatno spremljanje varnosti.“
English: Report that a company marketing medicines in the EU must submit to regulatory authorities periodically (e.g. every six months) that includes new reports of suspected adverse drug reactions.
Slovenian: Poročilo, ki ga mora poslovni subjekt, ki trži zdravila v EU, redno (npr. vsakih šest mesecev) pošiljati regulativnim organom in ki vključuje nova poročila o domnevnih neželenih učinkih zdravil.
English: This is achieved via comprehensive comparability studies with the reference medicine (figure 5), and on the basis of solid pharmaceutical quality data.
Slovenian: To se doseže s celovitimi primerjalnimi študijami z referenčnim zdravilom (slika 5) in na podlagi zanesljivih podatkov o farmacevtski kakovosti.
English: Definitions
Slovenian: Definicije
English: Most biological medicines are made by biotechnology, often using sophisticated cell systems and recombinant DNA technology.
Slovenian: Večina bioloških zdravil se proizvaja z biotehnologijo, pogosto z uporabo visoko razvitih celičnih sistemov in tehnologijo rekombinantne DNK.
English: International nonproprietary name
Slovenian: Mednarodno nelastniško ime (angl. International nonproprietary name)