FrancophonIA/ELRC3.0 huggingface dataset:
English: stability of the active substance and finished product during shelf-life under defined storage conditions
Danish: det virksomme stofs og det færdige produkts stabilitet i holdbarhedsperioden under definerede opbevaringsforhold
English: As healthcare professionals are at the forefront of patients' care, it is vital that they have access to reliable information on these medicines: what they are and what scientific principles support their clinical development, approval and safety monitoring.
Danish: Fordi sundhedspersoner er tættest på pateinternes behandling og pleje, er det vigtigt, at de har adgang til pålidelige oplysninger om disse lægemidler: hvad de er, og hvilke videnskabelige principper der ligger bag deres kliniske udvikling, godkendelse og sikkerhedsovervågning.
English: Equivalence margins are set specifically for the indication studied and depend on the endpoint chosen.
Danish: Ækvivalensmarginer fastsættes specifikt for den undersøgte indikation og afhænger af det valgte endepunkt.
English: Factors affecting the number and types of clinical studies to be carried out for approval Determining factor
Danish: Faktorer, der påvirker antallet og typen af kliniske studier med henblik på godkendelse Bestemmende faktor
English: This minor variability must fall within the acceptable range to ensure consistent safety and efficacy.
Danish: Denne mindre variation skal ligge inden for det acceptable interval for at sikre ensartet sikkerhed og virkning.
English: Pharmacodynamic studies in vivo (animal models) are only done if no suitable in vitro model exists.
Danish: Farmakodynamiske in vivo-studier (dyremodeller) udføres kun, hvis der ikke er nogen egnet in vitro-model.
English: World Health Organisation
Danish: Verdenssundhedsorganisationen
English: Medicines are approved when studies on their pharmaceutical quality, safety and efficacy convincingly demonstrate that the medicine's benefits outweigh the risks (‘positive benefit-risk balance').
Danish: Lægemidler godkendes, når studier af deres farmaceutiske kvalitet, sikkerhed og virkning på en overbevisende måde viser, at lægemidlets fordele opvejer risiciene (“positivt benefit/riskforhold”).
English: Insulin glargine Somatropin (growth hormone) Teriparatide
Danish: Follitropin alfa Insulin glargin Somatropin (væksthormon) Teriparatid
English: Therapeutic Goods Administration (Australia's medicines regulatory authority)
Danish: Therapeutic Goods Administration (Australiens regulerende myndighed for lægemidler)
English: Rarely, however, an immune reaction against a biological medicine could be serious and life-threatening.
Danish: I sjældne tilfælde kan en immunreaktion på et biologisk lægemiddel imidlertid være alvorlig og livstruende.
English: Once the period of market protection of the reference medicine expires (usually 10 years), companies can market approved biosimilars.
Danish: Når markedsbeskyttelsesperioden for referencelægemidlet (normalt 10 år) udløber, kan virksomheder markedsføre godkendte biosimilære lægemidler.
English: Companies applying for marketing authorisation in the EU must submit a risk management plan (RMP) for each new medicine, including biological medicines.
Danish: Virksomheder, der ansøger om markedsføringstilladelse i EU, skal indsende en risikostyringsplan (RMP) for hvert nyt lægemiddel, herunder biologiske lægemidler.
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.
Danish: I USA er kravene til FDA-godkendelse af biosimilære lægemidler baseret på den samme videnskabelige tankegang som i EU, selv om de specifikke datakrav kan variere mellem de to regioner på grund af forskellige lovrammer.
English: Biological medicines are made by living organisms, which are naturally variable.
Danish: Biologiske lægemidler er fremstillet af levende organismer, der er naturligt varierende.
English: If a signal is suspected, it is evaluated by EMA's scientific committees, which will determine if any action is needed.
Danish: Hvis der er mistanke om et sådant signal, vurderes det af EMA's videnskabelige udvalg, som vil afgøre, om der skal træffes foranstaltninger.
English: Although immunogenicity could be a potential concern for all biological medicines, there are several important considerations:
Danish: Selv om immunogenicitet kan give anledning til bekymring ved alle biologiske lægemidler, er der en række vigtige betragtninger:
English: Conventional clinical trials to demonstrate efficacy and safety in all claimed therapeutic indications
Danish: Konventionelle kliniske forsøg for at påvise virkning og sikkerhed i alle påberåbte terapeutiske indikationer
English: Nearly all biosimilars approved for use in the EU have been approved centrally, as they use biotechnology for their production.
Danish: Næsten alle biosimilære lægemidler, der er godkendt til anvendelse i EU, er godkendt centralt, fordi der anvendes bioteknologi i fremstillingen heraf.
English: Other international regulators such as Australia's TGA directly apply the principles set out in the EU legislation for the development and approval of biosimilars.
Danish: Andre regulerende myndigheder, f.eks. TGA i Australien, anvender direkte principperne i EU-lovgivningen for udvikling og godkendelse af biosimilære lægemidler.
English: European Medicines Agency: Similar biological medicinal products (overarching guideline).
Danish: Det Europæiske Lægemiddelagentur: Similar biological medicinal products (overarching guideline).
English: Adverse drug reaction An unwanted medical event following the use of a medicine.
Danish: En uønsket medicinsk hændelse efter anvendelsen af et lægemiddel.
English: Technology that involves combining sequences of DNA that do not occur naturally, for example inserting a gene for producing a therapeutic protein.
Danish: Teknologi, der indebærer kombination af DNA-sekvenser, som ikke forekommer naturligt, f.eks. indsættelse af et gen til fremstilling af terapeutiske proteiner.
English: Minor change (e.g. adding a more sensitive test method to characterise the active substance)
Danish: Mindre ændring (f.eks. at tilføje en mere sensitiv testmetode til karakterisering af det virksomme stof)
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.
Danish: Det er særlig vigtigt at få oplysning om sjældne immunreaktioner, der kun kan opdages efter en lang opfølgningsperiode hos et større antal patienter.
English: Thus, the active substance in the final biological medicine can have an inherent degree of minor variability
Danish: Det virksomme stof i det endelige biologiske lægemiddel kan derfor have en iboende grad af mindre variation
English: These endpoints should preferably measure the pharmacological activity of the medicine and be less influenced by patient- or disease-related factors.
Danish: Endepunkterne bør helst måle lægemidlets farmakologiske aktivitet og i mindre grad være påvirket af patient- eller sygdomsrelaterede faktorer.
English: The EU has a well-established system for monitoring, reporting, assessing and preventing adverse drug reactions for all medicines, including all biological medicines.
Danish: EU har en veletableret ordning for overvågning, rapportering, vurdering og forebyggelse af bivirkninger af alle lægemidler, herunder alle biologiske lægemidler.
English: Technology that relies on biological systems, living organisms or components from living organisms (such as genes or enzymes) to make a specific product.
Danish: Teknologi, som benytter biologiske systemer, levende organismer eller komponenter fra levende organismer (f.eks. gener eller enzymer) til fremstilling af et specifikt produkt.
English: In general, it is expected that biosimilars will be introduced to the market at a lower price than their reference medicine.
Danish: Generelt forventes det, at biosimilære lægemidler markedsføres til en lavere pris end deres referencelægemidler.
English: The scientific criteria for extrapolation of efficacy and safety data are supported by over 10 years experience of safe and effective use of biosimilars in the EU.
Danish: De videnskabelige kriterier for ekstrapolering af data om virkning og sikkerhed understøttes af over 10 års erfaring med sikker og effektiv brug af biosimilære lægemidler i EU.
English: A medicine obtained by biotechnology often has been produced by inserting a gene into cells so that they can produce the desired protein.
Danish: Et bioteknologisk fremstillet lægemiddel er ofte fremstillet ved at indsætte et gen i celler, så de kan producere det ønskede protein.
English: Data requirements for approval: a scientifically tailored package
Danish: Datakrav til godkendelse: En videnskabeligt skræddersyet pakke
English: Post-translational change
Danish: Posttranslationel modifikation
English: Safety data are collected throughout the clinical development programme, including during PK and PD studies.
Danish: Sikkerhedsdata indsamles under hele det kliniske udviklingsprogram, herunder som led i PK- og PD-studier.
English: Same pharmaceutical quality standards for all medicines
Danish: Samme farmaceutiske kvalitetsstandarder for alle lægemidler
English: This is because immunogenicity is determined by more than product-related characteristics.
Danish: Det skyldes, at immunogenicitet ikke alene bestemmes af produktrelaterede egenskaber.
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.
Danish: Ekstrapolering af data til andre indikationer er altid understøttet af solide fysisk-kemiske og in vitro-studier for at vurdere alle de mulige virkningsmekanismer.
English: The aim of studies in humans is not to demonstrate safety and efficacy in patients, as these have already been established for the reference medicine.
Danish: Formålet med studier på mennesker er ikke at påvise sikkerhed og virkning hos patienter, da det allerede er påvist for referencelægemidlet.
English: For each medicine approved through EMA, including biosimilars, EMA publishes a group of documents known as the european public assessment report (‘EPAR').
Danish: For hvert lægemiddel, der godkendes via EMA, herunder biosimilære lægemidler, offentliggør EMA en samling dokumenter, der kaldes den europæiske offentlige vurderingsrapport (“EPAR”).
English: Studies of how a medicine is processed by the body, including its absorption, distribution, biotransformation and excretion.
Danish: Studier af, hvordan et lægemiddel behandles i kroppen, herunder dets optagelse, fordeling, biotransformation og udskillelse.
English: The quality of all medicines (biological and nonbiological) approved in the EU is rigorously proven.
Danish: Kvaliteten af alle lægemidler (biologiske og ikkebiologiske), som er godkendt i EU, er grundigt dokumenteret.
English: Full non-clinical data (pharmacology and toxicology)
Danish: Komplette non-kliniske data (farmakologi og toksikologi)
English: This is partly due to a tailored development programme that builds on scientific knowledge gained with the reference medicine and so avoids unnecessary repetition of non-clinical and clinical studies.
Danish: Det skyldes til dels et skræddersyet udviklingsprogram baseret på den videnskabelige viden, der er opnået med referencelægemidlet, så unødvendig gentagelse af non-kliniske og kliniske studier undgås.
English: The amount of data normally depends on the type and severity of the safety concerns identified for the reference medicine.
Danish: Mængden af data afhænger normalt af typen og omfanget af de sikkerhedsproblemer, som er konstateret for referencelægemidlet.
English: For questions on prescribing or interchangeability practices, information may be available at the national competent authority in the relevant Member State (the list can be found on EMA's website).
Danish: For spørgsmål om ordineringspraksis eller praksis for indbyrdes udskiftelighed findes der oplysninger hos den nationale kompetente myndighed i den relevante medlemsstat (se listen på EMA's websted).
English: There are certain key aspects that need to be considered for the design of comparative clinical trials:
Danish: Visse vigtige aspekter skal overvejes i forbindelse med udformningen af sammenlignende kliniske forsøg:
English: Why biosimilars are not considered generic medicines
Danish: Hvorfor biosimilære lægemidler ikke betragtes som generiske lægemidler
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.
Danish: Kriterierne for at afgøre, om der er behov for en sikkerhedsundersøgelse efter markedsføring, er de samme for alle lægemidler, herunder biosimilære lægemidler og deres referencelægemidler.
English: Healthcare professionals play an essential role in contributing to the understanding of a medicine's safety profile during clinical use.
Danish: Sundhedspersoner spiller en afgørende rolle i at skabe forståelse for et lægemiddels sikkerhedsprofil i klinisk anvendelse.
English: Over the years, EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
Danish: I årenes løb har EMA publiceret videnskabelige retningslinjer som en hjælp til udviklere til at overholde de strenge lovkrav for godkendelse af biosimilære lægemidler.
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).
Danish: Den potentielle effekt af disse ændringer på det biologiske lægemiddels kliniske effekt vurderes omhyggeligt i forbindelse med sammenlignelighedsstudier (hovedsagelig studier af kvalitet og in vitro-studier).
English: Variability of biosimilar kept within strict limits
Danish: Biosimilære lægemidlers variation holdes inden for snævre grænser
English: Compared with small chemical substances, biological medicines consist of large and often complex molecular structures.
Danish: Sammenlignet med små kemiske stoffer består biologiske lægemidler af store og ofte komplekse molekyler.
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.
Danish: Planen, som er skræddersyet til det enkelte produkt, omfatter en lægemiddelovervågningsplan og foranstaltninger til minimering af risiko for at identificere, karakterisere og minimere et lægemiddels vigtige risici.
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.
Danish: Producenterne i EU skal have en fremstillingstilladelse og er retligt forpligtet til at overholde God Fremstillingspraksis (GMP), de aftalte standarder for at få et lægemiddel af dokumenteret kvalitet.
English: If clinical studies are needed, these are conducted in one relevant indication and, based on all these data, extrapolation to the other indications is usually possible.
Danish: Hvis der er behov for kliniske studier, gennemføres de i én relevant indikation, og på grundlag af alle disse data er det normalt muligt at ekstrapolere til de andre indikationer.
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.
Danish: Myndigheder evaluerer kontinuerligt benefit/risk-forholdet for alle lægemidler og træffer de nødvendige regulatoriske foranstaltninger (f.eks. ved at indføre nye advarsler i produktinformationen eller begrænse anvendelsen) for at beskytte den offentlige sundhed.
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.
Danish: Faktorer vedrørende patienter (alder, immunstatus), sygdom (komorbiditet, samtidige behandlinger), eller behandlingsrelaterede faktorer (administrationsmetode, eksponeringens længde) skal også tages i betragtning.
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.
Danish: Toksikologiske in vivostudier kræves kun i visse tilfælde, f.eks. hvis det biosimilære lægemiddel fremstilles i en ny type celle eller organisme, eller hvis formuleringen indeholder nye hjælpestoffer, som ikke er anvendt tidligere.
English: Safety monitoring of long-term or long-latency events for biological medicines follows the same principles as for small-molecule medicines.
Danish: Sikkerhedsovervågning af hændelser på langt sigt eller med lang latenstid for biologiske lægemidler følger samme principper som for småmolekylære lægemidler.
English: In practice, variability (within a batch or batch-to-batch) is very low when using the same manufacturing process.
Danish: I praksis er variationen (inden for en batch eller mellem batches) meget lille, når fremstillingsprocessen er den samme.
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
Danish: Forsøg, hvis hovedformål er at sammenligne med placebo eller en nuværende behandlingsstandard med "hårde" endepunkter (f.eks. langsigtet resultat, mortalitet, strukturelle skader) og en relevant patientpopulation for at påvise gavnlig virkning
English: Comparability: a scientific principle routinely used after manufacturing changes to medicines on the market
Danish: Sammenlignelighed: Et videnskabeligt princip, der anvendes rutinemæssigt efter ændringer af fremstilling af lægemidler på markedet
English: Companies can market approved biosimilars once the period of market protection of the reference medicine expires (after 10 years).
Danish: Virksomheder kan markedsføre godkendte biosimilære lægemidler, når markedsbeskyttelsen af referencelægemidlet udløber (efter 10 år).
English: Most often, analytical and functional data are sufficient, and clinical trials to prove safety and efficacy are not needed (table 5, scenario 1 and 2).
Danish: I de fleste tilfælde er analytiske og funktionelle data tilstrækkelige, og der er ikke behov for kliniske forsøg for at dokumentere sikkerhed og virkning (tabel 5, scenarie 1 og 2).
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).
Danish: Når det virksomme stof er et protein, skal både det biosimilære lægemiddel og referencelægemidlet indeholde det samme protein (dvs. aminosyresekvens) og samme “3D”struktur (proteinfoldning).
English: This avoids unnecessary repetition of clinical trials already carried out with the reference medicine.
Danish: Hermed undgås unødvendig gentagelse af kliniske forsøg, der allerede er udført med referencelægemidlet.
English: Fusion proteins
Danish: Fusionsproteiner
English: Regulators have built up extensive experience to conclude that such differences do not affect the medicine's quality, safety and efficacy.
Danish: De regulerende myndigheder har stor erfaring med at konkludere, at sådanne forskelle ikke påvirker lægemidlets kvalitet, sikkerhed og virkning.
English: A plan to manage risks always in place
Danish: Der er altid en plan for risikostyring
English: This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular microheterogeneity.
Danish: Det skyldes hovedsagelig, at biologiske lægemidlers naturlige variation og mere komplekse fremstilling ikke giver mulighed for præcis gengivelse af den molekylære mikroheterogenitet.
English: The black triangle symbol identifies medicines under additional monitoring.
Danish: Det sorte trekantssymbol viser, at lægemidlet er underlagt supplerende overvågning.
English: To compare the pharmacological effects, a sensitive endpoint that allows detection of product-specific differences should be chosen.
Danish: For at sammenligne de farmakologiske effekter bør der vælges et sensitivt endepunkt, som giver mulighed for at afdække produktspecifikke forskelle.
English: Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety.
Danish: I dag er biosimilære lægemidler en integreret del af de effektive biologiske behandlingsformer, der findes i EU, med tilstrækkelige sikkerhedsforanstaltninger til at beskytte patientsikkerheden.
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.
Danish: I forbindelse med biosimilære lægemidler og referencelægemidler er det vigtigt, at sundhedspersoner får kendskab til terminologien vedrørende indbyrdes udskiftelighed/ interchangability og substitution i EU.
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.
Danish: Det virksomme stofs virkningsmekanisme bør igangsættes af den/de samme receptorer i både den oprindelige og den ekstrapolerede indikation.
English: Companies producing biological medicines are likely to adapt or improve the manufacturing process several times during the commercial life of a product (e.g. by increasing production scale).
Danish: Virksomheder, der fremstiller biologiske lægemidler, vil sandsynligvis tilpasse eller forbedre fremstillingsprocessen flere gange i løbet af et produkts kommercielle levetid (f.eks. ved at øge produktionens størrelse).
English: From a scientific and regulatory point of view, the reference medicine's entire clinical development programme does not need to be repeated.
Danish: Ud fra et videnskabeligt og regulatorisk synspunkt er der ikke behov for at gentage hele det kliniske udviklingsprogram, som referencelægemidlet har gennemgået.
English: European Medicines Agency: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
Danish: Det Europæiske Lægemiddelagentur: ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products.
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.
Danish: Undersøgelser efter markedsføring giver mulighed for overvågning af kendte risici og også for at opdage sjældne bivirkninger, der kun opstår, når et stort antal patienter er blevet behandlet i en lang periode.
English: This is why additional pharmacovigilance activities (such as including patients in registries) could be required in certain cases.
Danish: Derfor kan yderligere lægemiddelovervågningsaktiviteter (som at føre patientregistre) være påkrævet i visse tilfælde.
English: European Medicines Agency: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
Danish: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
English: The EU has pioneered the regulation of biosimilars since the approval of the first one (the growth hormone somatropin) in 2006.
Danish: EU er gået forrest i reguleringen af biosimilære lægemidler siden godkendelsen af det første af slagsen (væksthormonet somatropin) i 2006.