FrancophonIA/ELRC3.0 huggingface dataset:
English: For larger molecules (e.g. monoclonal antibodies), even when robust quality and in vitro comparability data are provided, a comparative study in patients using a conventional clinical efficacy endpoint is usually required.
Danish: For større molekyler (f.eks. monoklonale antistoffer), selv når der foreligger solide sammenlignelighedsdata for kvalitet og in vitro, kræves der normalt et sammenlignende studie hos patienter ved hjælp af et konventionelt klinisk endepunkt for virkning.
English: Comparative quality studies
Danish: Sammenlignende kvalitetsstudier
English: Clinical trials for biosimilars do not need to include all the pivotal studies conducted for the reference medicine to prove safety and efficacy in humans.
Danish: Kliniske forsøg for biosimilære lægemidler behøver ikke at omfatte alle de centrale studier, der er udført for referencelægemidlet, for at vise sikkerheden og virkningen hos mennesker.
English: This also binds the company to register the study in the publicly available EU PAS Register: http://www.encepp.eu/ encepp_studies/indexRegister.shtml.
Danish: Det forpligter også virksomheden til at registrere undersøgelsen i det offentligt tilgængelige EU PAS-register: http://www.
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.
Danish: Ordinerende læger kan med sindsro anvende biologiske lægemidler (herunder biosimilære lægemidler) i alle de godkendte indikationer, da alle godkendte indikationer for et lægemiddel er baseret på videnskabelige beviser.
English: Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use.
Danish: Siden EU godkendte det første biosimilære lægemiddel i 2006, har sundhedspersoner fået mere og mere erfaring med anvendelsen af disse lægemidler.
English: Indications of the reference medicine can be approved for the biosimilar in the absence of specific clinical data generated with the biosimilar (‘extrapolation of indications').
Danish: Mulighed for at ekstrapolere til andre indikationer Referencelægemidlets indikationer kan godkendes for det biosimilære lægemiddel i mangel af specifikke kliniske data, der er genereret med det biosimilære lægemiddel (“ekstrapolering af indikationer”).
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
Danish: Kliniske forsøg, hvis hovedformål er at påvise klinisk ækvivalens med referencelægemidlet ved hjælp af sensitive endepunkter i en population, hvor produktrelaterede forskelle i klinisk effekt kan påvises
English: It is important that the medicine's tradename and batch number are recorded by healthcare professionals at all levels, including dispensing and patient administration.
Danish: Det er vigtigt, at sundhedspersoner på alle niveauer registrerer lægemidlets handelsnavn og batchnummer, herunder ved udlevering og administration.
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.
Danish: Konkurrence inden for biosimilære lægemidler kan være en fordel for sundhedssystemerne i EU, fordi den forventes at give patienterne bedre adgang til sikre og effektive lægemidler af dokumenteret kvalitet.
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.
Danish: Biologiske lægemidler godkendes på grundlag af en acceptabel sikkerhedsprofil, og de bør anvendes som anbefalet i produktresuméet og indlægssedlen.
English: If a patient is switched from one biological medicine to another with the same active substance, it is important to record the tradename and batch number for each of the medicines.
Danish: Hvis der for en patient skiftes fra et biologisk lægemiddel til et andet med samme virksomme stof, er det vigtigt at registrere begge lægemidlers handelsnavn og batchnummer.
English: European Medicines Agency: Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues.
Danish: Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues.
English: There may be minor differences from the reference medicine which are not clinically meaningful in terms of safety or efficacy.
Danish: Der kan forekomme mindre forskelle i forhold til referencelægemidlet, men de er ikke klinisk relevante med hensyn til sikkerhed og virkning.
English: European Medicines Agency: Similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues.
Danish: Similar biological medicinal products containing biotechnology- derived proteins as active substance: non-clinical and clinical issues.
English: For biosimilars, a positive benefit-risk balance is based on demonstrating biosimilarity, i.e. that the active substance is highly similar to the reference medicine (figure 4).
Danish: For biosimilære lægemidler er et positivt benefit/ risk-forhold baseret på dokumentation af biosimilaritet, dvs. at det virksomme stof i høj grad ligner referencelægemidlet (figur 4).
English: Development based on demonstration of biosimilarity using comparability studies (comprehensive head-to-head comparison of the biosimilar with the reference medicine to show high similarity in chemical structure, biological function, efficacy, safety and immunogenicity)
Danish: Udvikling baseret på påvisning af biosimilaritet ved hjælp af sammenlignelighedsstudier (omfattende head-to-head-sammenligning af det biosimilære lægemiddel med referencelægemidlet for at påvise høj grad af similaritet med hensyn til kemisk struktur, biologisk funktion, virkning, sikkerhed og immunogenicitet)
English: Comparison of the biosimilar with the reference medicine involves extensive comparability studies to assess any possible impact on safety and efficacy.
Danish: Sammenligning af det biosimilære lægemiddel med referencelægemidlet inkluderer omfattende studier af sammenlignelighed for at vurdere en eventuel påvirkning af sikkerhed og virkning.
English: An increasing number of biological medicines are ‘biosimilars' - medicines highly similar in all essential aspects to an already approved biological medicine.
Danish: Flere og flere biologiske lægemidler er “biosimilære lægemidler” - som på alle væsentlige områder i høj grad ligner et allerede godkendt biologisk lægemiddel.
English: Most biological medicines in current clinical use contain active substances made of proteins.
Danish: De fleste biologiske lægemidler, der aktuelt er i klinisk anvendelse, indeholder proteiner som virksomme stoffer.
English: Similar biotherapeutic products (WHO term for biosimilars)
Danish: Similære bioterapeutiske produkter (WHO's betegnelse for biosimilære lægemidler)
English: Glycosylation
Danish: Glykosylering
English: Examples of types of proteins in biological medicines approved in the EU
Danish: Eksempler på biologiske proteinlægemidler godkendt i EU
English: There is also no reason to believe that harmful immunogenicity should be expected after switching between highly similar biological medicines
Danish: Der er heller ingen grund til at forvente immunogenicitit når der skiftes mellem biosimilære lægemidler8.
English: EPAR summaries for biosimilars can be accessed by searching for the medicine's name on EMA's homepage.
Danish: EPAR-sammendrag for biosimilære lægemidler kan findes ved at søge på lægemidlets navn på EMA's websted.
English: The biosimilar's SmPC mentions the name of the active substance (i.e. INN) and not the tradename of the reference medicine.
Danish: I produktresuméet for det biosimilære lægemiddel nævnes navnet på det virksomme stof (INN) og ikke referencelægemidlets handelsnavn.
English: Biosimilar Working Party (EMA's working party of EU experts on biosimilars)
Danish: Arbejdsgruppen om biosimilære lægemidler (EMA's arbejdsgruppe af EU-eksperter om biosimilære lægemidler)
English: Comparative clinical studies Safety and efficacy PK/PD
Danish: Sammenlignende kliniske studier Sikkerhed og virkning PK/PD
English: Practice of dispensing one medicine instead of another equivalent and interchangeable medicine at pharmacy level without consulting the prescriber.
Danish: Udlevering af et lægemiddel i stedet for et andet tilsvarende og indbyrdes udskifteligt lægemiddel på apoteket uden at konsultere den ordinerende læge.
English: Comparative non-clinical studies Pharmacodynamic
Danish: Sammenlignende non-kliniske studier Farmakodynamiske
English: Step 1 Comparative quality studies
Danish: Trin 1 sammenlignende studier af kvaliteten
English: Biosimilarity
Danish: Biosimilaritet
English: EMA does not regulate interchangeability, switching and substitution of a reference medicine by its biosimilar.
Danish: EMA regulerer ikke indbyrdes udskiftelighed, skift og substitution mellem et referencelægemiddel og det tilsvarende biosimilære lægemiddel.
English: Same safety monitoring for all biological medicines
Danish: Samme sikkerhedsovervågning af alle biologiske lægemidler
English: Some differences may be allowed if they have no effect on safety and efficacy - for example differences in the formulation of the medicine (e.g. excipients), presentation (e.g. powder to be reconstituted versus solution ready for injection) and administration device (e.g. type of delivery pen).
Danish: Visse forskelle kan tillades, hvis de ikke påvirker sikkerheden og virkningen - f.eks. forskelle i lægemidlets formulering (f.eks. hjælpestoffer), konsistens (f.eks. pulver, der skal rekonstitueres, over for en opløsning, som er klar til injektion) og administrationsanordning (f.eks. pentype).
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.
Danish: For biologiske lægemidler med en lav immunogenicitetsprofil (f.eks. filgrastim) testes patienterne normalt hyppigt for antistoffer ved begyndelsen og afslutningen af det kliniske studie med en kortere opfølgningsperiode og løbende lægemiddelovervågningsforanstaltninger til styring af eventuelle risici.
English: Key features of biological medicines
Danish: De vigtigste kendetegn ved biologiske lægemidler
English: Pharmaceutical quality studies
Danish: Studier af farmaceutisk kvalitet
English: Safety monitoring for all biological medicines, including biosimilars
Danish: Sikkerhedsovervågning af alle biologiske lægemidler, herunder biosimilære lægemidler
English: Comparative clinical and non-clinical studies that support the approval of a biosimilar rule out differences which may affect the medicine's safety and efficacy.
Danish: Sammenlignende kliniske og nonkliniske studier, som underbygger godkendelse af et biosimilært lægemiddel, udelukker forskelle, der kan påvirke lægemidlets sikkerhed og virkning.
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.
Danish: Derfor kræver myndighedsgodkendelse af biosimilære lægemidler flere studier, end det er tilfældet for generiske lægemidler, for at sikre, at mindre forskelle ikke påvirker sikkerheden eller virkningen.
English: For a biological medicine, its tradename, INN and batch number can be found in the product packaging.
Danish: Biologiske lægemidlers handelsnavn, INN og batchnummer står på produktets emballage.
English: Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine.
Danish: Biosimilære lægemidlers sikkerhed er underlagt lægemiddelovervågning på samme måde som alle andre lægemidler.
English: Extrapolation
Danish: Ekstrapolering
English: Step 3 Comparative clinical studies
Danish: Trin 3 Sammenlignende kliniske studier
English: Strict controls are always in place during manufacturing to ensure that minor differences do not affect the way the medicine works or its safety.
Danish: Det kontrolleres altid strengt under fremstillingen, at mindre forskelle ikke påvirker lægemidlets virkemåde eller sikkerhed.
English: Non-clinical studies
Danish: Non-kliniske studier
English: Deoxyribonucleic acid
Danish: Deoxyribonukleinsyre
English: Strict control of the quality of biological medicines
Danish: Streng kvalitetskontrol med biologiske lægemidler
English: Obtained from a biological source
Danish: Fremstillet fra en biologisk udgangsmateriale
English: Details of the studies with the biosimilar as well as the tradename of the reference medicine can be found in EMA's assessment report, available on EMA's website.
Danish: Nærmere oplysninger om studierne med det biosimilære lægemiddel samt referencelægemidlets handelsnavn kan findes i EMA's vurderingsrapport på EMA's hjemmeside.
English: Clinical studies that support the approval of a biosimilar confirm that any differences will not have an effect on safety and efficacy.
Danish: Kliniske studier, der ligger til grund for godkendelsen af et biosimilært lægemiddel, bekræfter, at eventuelle forskelle ikke har nogen effekt på sikkerheden og virkningen.
English: A statement has been introduced in the SmPC to remind healthcare professionals of the need to clearly record the tradename and batch number in the patient's healthcare records.
Danish: Produktresuméet indeholder en tekst, der skal påminde sundhedspersoner om, hvor vigtigt det er at registrere handelsnavn og batchnummer tydeligt i patientjournalen.
English: Alternatively, they can download it from EMA's website.
Danish: De kan også hente den på EMA's hjemmeside.
English: Potential for immunogenicity
Danish: Potentiale for immunogenicitet
English: Accessed on 10 April 2017.
Danish: Sidst tilgået den 10. april 2017.
English: Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilar medicines and their reference medicines.
Danish: I løbet af de seneste 10 år har EU's system til overvågning af sikkerheden ikke påvist relevante forskelle i karakteren, graden eller hyppigheden af bivirkninger mellem biosimilære lægemidler og deres referencelægemidler.
English: Development and approval of biosimilars in the EU
Danish: Udvikling og godkendelse af biosimilære lægemidler i EU
English: These studies include pharmacodynamic studies in vitro, which look at binding and activation (or inhibition) of physiological targets and immediate physiological effects in cells.
Danish: Trin 2 Sammenlignende non-kliniske studier Disse studier omfatter farmakodynamiske in vitrostudier til vurdering af binding og aktivering (eller hæmning) og umiddelbare fysiologiske effekter i celler.
English: Demonstration of biosimilarity relies on comprehensive comparability studies with the reference medicine.
Danish: Påvisning af biosimilaritet bygger på omfattende sammenlignelighedsstudier med referencelægemidlet.
English: Anti-drug antibody
Danish: Anti-drug-antistof
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.
Danish: Omfattende studier skal vise sammenlignelighed (ved hjælp af data om sikkerhed virkning og immunogenicitet), af det biosimilære lægemiddel og referencelægemidlet i en central indikation i en population, hvor der kan konstateres potentielle forskelle i klinisk effekt.
English: Accessed on 14 March 2017.
Danish: Sidst tilgået den 14. marts 2017.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.
Danish: Du kan finde yderligere oplysninger på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Accessed on 6 March 2017.
Danish: Sidst tilgået den 6. marts 2017.
English: Details of how each biosimilar was developed and on the comparability studies to demonstrate biosimilarity are given in their assessment reports.
Danish: Nærmere oplysninger om udviklingen af hvert enkelt biosimilært lægemiddel og om studierne af sammenlignelighed for at påvise biosimilaritet findes i lægemidlets vurderingsrapport.
English: Potential immunogenicity
Danish: Potentiel immunogenicitet
English: A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (the so-called ‘reference medicine').
Danish: Et biosimilært lægemiddel er et biologisk lægemiddel, som i høj grad ligner et andet biologisk lægemiddel, der allerede er godkendt i EU (det såkaldte “referencelægemiddel”).
English: Since biosimilars are a type of biological medicine, all features pertinent to biological medicines apply.
Danish: Da biosimilære lægemidler er biologiske lægemidler, har de alle de samme karakteristika som biologiske lægemidler.
English: As for all clinical trials, legal requirements (e.g. Good Clinical Practice) have to be met.
Danish: Lovkravene (f.eks. god klinisk praksis) skal opfyldes som for alle kliniske forsøg.
English: These minor differences are not clinically meaningful, i.e. no differences are expected in safety and efficacy.
Danish: De har ingen klinisk betydning, dvs. der forventes ingen forskelle med hensyn til sikkerhed og virkning.
English: If a suspected ADR is identified for a biological medicine, healthcare professionals should report it, taking care to include the tradename and batch number of the medicine.
Danish: Hvis der identificeres en formodet bivirkning af et biologisk lægemiddel, bør sundhedspersoner indberette den, med omhyggelig angivelse af lægemidlets handelsnavn og batchnummer.
English: Depending on the amount and type of sugar groups added, the biological activity can change.
Danish: Den biologiske aktivitet kan ændre sig, afhængigt af mængden og typen af tilsatte sukkergrupper.
English: Comparability studies needed
Danish: Krav til sammenlignelighedsstudier
English: Builds on knowledge of safety and efficacy from years of clinical use with reference medicine
Danish: Ingen tidligere viden om sikkerhed og virkning Bygger på viden om sikkerhed og virkning fra adskillige års kliniske brug af referencelægemidlet
English: Since the EU approved the first biosimilar medicine (‘biosimilar') in 2006, the EU has pioneered the regulation of biosimilars.
Danish: Siden godkendelsen af det første biosimilære lægemiddel i 2006 er EU gået forrest i reguleringen af biosimilære lægemidler.
English: Pharmacodynamic studies
Danish: Farmakodynamiske studier
English: Pharmacokinetic studies
Danish: Farmakokinetiske studier
English: Natural variability is inherent to all biological medicines and strict controls are always in place to ensure that it does not affect the way the medicine works or its safety.
Danish: Naturlig variation forekommer i alle biologiske lægemidler, og der er altid streng kontrol for at sikre, at det ikke påvirker lægemidlets virkemåde eller sikkerhed.
English: General considerations on safety for biosimilars
Danish: Generelle betragtninger om biosimilære lægemidlers sikkerhed
English: Data included in the prescribing information and EMA assessment reports for biosimilars
Danish: Data i ordineringsoplysninger samt EMAvurderingsrapporter for biosimilære lægemidler
English: If there are no suitable PD endpoints, a clinical efficacy trial comparing the biosimilar and its reference medicine is generally needed.
Danish: I mangel af egnede PD-endepunkter er det som udgangspunkt nødvendigt at udføre et klinisk forsøg af virkning, som sammenligner det biosimilære lægemiddel og referencelægemidlet.
English: Summary
Danish: Sammendrag
English: Kurki P, van Aerts L, Wolff-Holz E, et al. Interchangeability of biosimilars: a European perspective.
Danish: Kurki P, van Aerts L, Wolff-Holz E, m.fl.
English: The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
Danish: Retningslinjerne tilpasses løbende for at holde trit med de hurtige fremskridt inden for bioteknologi og analytiske videnskaber.
English: Specific features of biosimilar medicines Highly similar to the reference medicine
Danish: Særlige kendetegn ved biosimilære lægemidler Høj grad af similaritetmed referencelægemidlet
English: Comparison of development and characteristics between generics and biosimilars Generic medicine
Danish: Sammenligning af generiske og biosimilære lægemidlers udvikling og karakteristika Generiske lægemidler
English: In cases where the product is dispensed at a community pharmacy, the tradename and batch number of the biological medicine should be provided to the patient.
Danish: I tilfælde hvor produktet udleveres fra et lokalt apotek, oplyses patienten om det biologiske lægemiddels handelsnavn og batchnummer.
English: When the prescriber decides to exchange one medicine for another medicine with the same therapeutic intent.
Danish: Når den ordinerende læge beslutter at skifte fra et lægemiddel til et andet lægemiddel med samme terapeutiske formål.
English: The range of variability allowed for a biosimilar is the same as that allowed between batches of the reference medicine.
Danish: Det tilladte interval for variation er det samme for et biosimilært lægemiddel som mellem batches af referencelægemidlet.
English: Alternatively, a live list of EPAR summaries for all biosimilars can be found on EMA's website.
Danish: Alternativt findes en liste, der løbende opdateres, for alle biosimilære lægemidler på EMA's websted.
English: Reference medicine
Danish: Referencelægemiddel
English: Extrapolation is not a new concept but a well-established scientific principle used routinely when biological medicines with several approved indications undergo major changes to their manufacturing process (e.g. to introduce a new formulation).
Danish: Ekstrapolering er ikke et nyt begreb, men et veletabelret videnskabeligt princip, som anvendes rutinemæssigt, når fremstillingsprocessen for biologiske lægemidler med flere godkendte indikationer ændres væsentligt (f.eks. når der indføres en ny formulering).
English: EU post-authorisation study register
Danish: Register over EU's undersøgelser efter tilladelse til markedsføring
English: Communicating with patients on biosimilars
Danish: Kommunikation med patienter om biosimilære lægemidler
English: Process for approval of biosimilars in the EU
Danish: Procedure for godkendelse af biosimilære lægemidler i EU
English: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands
Danish: 1083 HS Amsterdam
English: Implications of the availability of biosimilars
Danish: Konsekvenserne af, at biosimilære lægemidler er tilgængelige
English: If a biosimilar is highly similar to a reference medicine, and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data may be extrapolated to other indications already approved for the reference medicine.
Danish: Hvis et biosimilært lægemiddel er sammenligneligt med et referencelægemiddel og har sammenlignelig sikkerhed og virkning i én terapeutisk indikation, kan der ekstrapoleres data om sikkerhed og virkning til andre indikationer, som allerede er godkendt for referencelægemidlet.
English: Comparison of data requirements for approval of a biosimilar versus the reference medicine
Danish: Sammenligning af datakravene til godkendelse af et biosimilært lægemiddel i forhold til