FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapeutic Goods Administration (Australia's medicines regulatory authority)
Maltese: Therapeutic Goods Administration (l-awtorità regolatorja tal-Awstrija għall-mediċini)
English: Recombinant DNA technology
Maltese: Teknoloġija tad-DNA rikombinanti
English: Modification of a protein after its production, which involves the addition of carbohydrate (sugar) groups.
Maltese: Modifika ta' proteina wara l-produzzjoni tagħha, li tinvolvi ż-żieda ta' gruppi ta' karboidrati (zokkor).
English: In principle, adverse reactions related to the pharmacological action can be expected at similar frequency for the biosimilar and reference product, if functional, analytical, PK, PD and efficacy comparability data are robust.
Maltese: Fil-prinċipju, reazzjonijiet avversi relatati malazzjoni farmakoloġika jistgħu jkunu mistennija bi frekwenza simili għall-bijosimili u għall-prodott ta' referenza, jekk iddata ta' komparabbiltà funzjonali, analitika, PK, PD u taleffikaċja tkun robusta.
English: Batch 1
Maltese: Lott 1
English: Step 1
Maltese: Lot 1
English: http://www.ema.europa.
Maltese: Ibgħat mistoqsija www.ema.europa.eu/contact www.ema.europa.eu
English: Microheterogeneity Minor molecular variability among biological substances due to natural biological variability and slight alterations to production methods.
Maltese: Varjabbiltà molekulari minuri fost is-sustanzi bijoloġiċi minħabba varjabbiltà bijoloġika naturali u alterazzjonijiet ħfief għall-metodi ta' produzzjoni.
English: Sophisticated analytical methods (e.g. peptide mapping, mass spectrometry and assays in cells) are used to study their physicochemical and functional properties such as molecular structure, protein modifications and biological activity.
Maltese: Jintużaw metodi analitiċi sofistikati (eż. immappjar tal-peptidi, spettrometrija ta' massa u assaġġi f'ċelloli) biex jiġu studjati l-karatteristiċi fiżikokimiċi u funzjonali tagħhom bħall-istruttura molekulari, il-modifiki tal-proteini u l-attività bijoloġika.
English: Proteins Monoclonal antibodies
Maltese: Antikorpi monoklonali
English: Section 5.1 (pharmacodynamic properties) of the SmPC will identify a medicine as a biosimilar with the following wording:
Maltese: It-Taqsima 5.1 (karatteristiċi farmakodinamiċi) tal-SmPC se tidentifika mediċina bħala bijosimili bilkliem li ġej:
English: Pharmaceutical quality studies
Maltese: Studji tal-kwalità farmaċewtika
English: Batch 3
Maltese: Lott 3
English: Clinical studies Safety and efficacy PK/PD
Maltese: Studji kliniċi Sikurezza u effikaċja PK/PD
English: Potential for immunogenicity
Maltese: Potenzjal għal immunoġeniċità
English: Pharmacokinetic studies
Maltese: Studji farmakokinetiċi
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
Maltese: Is-sikurezza tal-bijosimili Kunsiderazzjonijiet ġenerali dwar is-sikurezza għall-bijosimili Monitoraġġ tas-sikurezza għall-mediċini bijoloġiċi kollha, inklużi l-bijosimili Traċċabilità: l-importanza li l-mediċini bijoloġiċi jiġu identifikati mill-isem kummerċjali u min-numru tal-lott Kif il-professjonisti fil-kura medika jistgħu jgħinu biex itejbu l-farmakoviġilanza għall-mediċini bijoloġiċi Id-data inkluża fl-informazzjoni tal-ħruġ ta' riċetta u fir-rapporti ta' valutazzjoni tal-EMA għall-bijosimili
English: Minor change (e.g. adding a more sensitive test method to characterise the active substance)
Maltese: Tibdil minuri (eż. żieda ta' metodu ta' ttestjar iktar sensittiv għall-karatterizzazzjoni tassustanza attiva)
English: Endpoints measuring pharmacodynamic activity (‘PD endpoints') can be used when available and when relevant for the medicine's clinical effect.
Maltese: Jistgħu jintużaw punti ta' tmiem li jkejlu l-attività farmakodinamika (“punti ta' tmiem PD”) meta jkunu disponibbli u rilevanti għalleffett kliniku tal-mediċina.
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.
Maltese: Dan jorbot lill-kumpanija wkoll sabiex tirreġistra l-istudju fir-Reġistru tal-PAS tal-UE li hu disponibbli pubblikament: http://www. encepp.eu/ encepp_studies/indexRegister.shtml.
English: Comparative quality studies
Maltese: Studji komparattivi tal-kwalità
English: Acceptance limits for important quality standards which an active substance or a finished medicine must meet.
Maltese: Limiti ta' aċċettazzjoni għal standards tal-kwalità importanti li sustanza attiva jew mediċina lesta trid tissodisfa.
English: 2016. http://ec.europa.eu/growth/toolsdatabases/newsroom/cf/itemdetail.cfm?item_ id=9066.
Maltese: Information for patients. 2016. http://ec.europa.eu/growth/ tools-databases/newsroom/cf/itemdetail.
English: Generic medicine
Maltese: Mediċina ġenerika
English: International nonproprietary name
Maltese: Denominazzjoni internazzjonali komuni
English: Modification of a protein after its production, which involves the attachment of molecules or groups such as phosphates or carbohydrates (sugars).
Maltese: Modifika ta' proteina wara l-produzzjoni ta' din, li tinvolvi l-hemża ta' molekuli jew ta' gruppi bħal fosfati jew karboidrati (zokkrijiet).
English: Full non-clinical data (pharmacology and toxicology)
Maltese: Data sħiħa mhux klinika (farmakoloġija u tossikoloġija)
English: Type of manufacturing change
Maltese: Prassi tajba ta' manifattura
English: Adalimumab Infliximab Rituximab Bevacizumab Trastuzumab
Maltese: Is-sikurezza tal-bijosimili hi ssorveljata permezz tal-attivitajiet tal-farmakoviġilanza, bl-istess mod bħal kwalunkwe mediċina oħra.
English: A robust regulatory framework for biosimilars
Maltese: Qafas regolatorju robust għall-bijosimili
English: Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety.
Maltese: Illum, il-bijosimili huma parti integrali mit-terapiji bijoloġiċi effettivi disponibbli fl-UE, appoġġjati minn salvagwardji adegwati li jipproteġu s-sikurezza tal-pazjenti.
English: eu/docs/en_GB/document_library/Scientific_ guideline/2014/10/WC500176768.pdf.
Maltese: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2014/10/WC500176768.pdf.
English: There may be minor differences from the reference medicine which are not clinically meaningful in terms of safety or efficacy.
Maltese: Jista' jkun hemm differenzi minuri mill-mediċina ta' referenza li mhumiex klinikament sinifikanti f'termini tas-sikurezza u tal-effikaċja.
English: Studies of the biochemical and physiological effects of a medicine in the body, including mechanism of action.
Maltese: Studji tal-effetti bijokimiċi u fiżjoloġiċi ta' mediċina fil-ġisem, inkluż mekkaniżmu ta' azzjoni.
English: Reference medicine
Maltese: Mediċina ta' referenza
English: The list of INNs, which is globally recognised and public property, is maintained by WHO.
Maltese: Il-lista ta' INNs, li hi rikonoxxuta globalment u pubblika, hi miżmuma mid-WHO.
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.
Maltese: Għal molekuli ikbar (eż. antikorpi monoklonali), anki meta tiġi pprovduta data tal-kwalità u tal-komparabilità in vitro robusta, normalment ikun meħtieġ studju komparattiv f'pazjenti billi jintuża l-punt ta' tmiem konvenzjonali li juri effikaċja klinika.
English: These include information on analytical and functional comparability, pharmacokinetics, clinical comparability and immunogenicity.
Maltese: Dawn jinkludu informazzjoni dwar il-komparabilità analitika u funzjonali, il-farmakokinetika, ilkomparabilità klinika u l-immunoġeniċità.
English: Biosimilar medicine
Maltese: Mediċina bijosimili
English: Fusion proteins
Maltese: Proteini tal-fużjoni
English: The EU has pioneered the regulation of biosimilars since the approval of the first one (the growth hormone somatropin) in 2006.
Maltese: L-UE kienet pijuniera tar-regolamentazzjoni tal-bijosimili mindu ġiet approvata l-ewwel waħda (l-ormon tattkabbir somatropin) fl-2006.
English: Refer to www.ema.europa.eu/how-to-find-us
Maltese: Refer to www.ema.europa.eu/how-to-find-us Telefown +31 (0)88 781 6000
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).
Maltese: Meta s-sustanza attiva tkun proteina, kemm ilbijosimili kif ukoll il-mediċina ta' referenza jrid ikun fihom l-istess proteina (jiġifieri s-sekwenza tal-amminoaċidi) u l-istess struttura “3D” (tiwi tal-proteina).
English: Bioequivalence
Maltese: Mikroeteroġenità
English: Step 3
Maltese: Lot 3
English: Collecting spontaneous adverse drug reactions and submitting PSURs
Maltese: Il-ġbir ta' reazzjonijiet avversi tal-mediċina spontanji u s-sottomissjoni ta' PSURs
English: The manufacture of biological medicines tends to be more complex than for chemically-derived molecules.
Maltese: Il-manifattura tal-mediċini bijoloġiċi għandha t-tendenza li tkun iktar kumplessa minn dik ta' molekuli derivati kimikament.
English: An increasing number of biological medicines are ‘biosimilars' - medicines highly similar in all essential aspects to an already approved biological medicine.
Maltese: Numru dejjem ikbar ta' mediċini bijoloġiċi huma “bijosimili” - mediċini ferm simili fl-aspetti essenzjali kollha għal mediċina bijoloġika diġà approvata.
English: Step 2
Maltese: Lot 2
English: Immunogenicity may be influenced by product characteristics (e.g. changes to the structure of the protein may occur during improper storage or transport, or proteins could form aggregates), but also by treatment-related factors (e.g. the risk may vary with subcutaneous versus intravenous administration or with continuous versus intermittent treatment regimen) and patient- or disease- related factors (e.g. age, genetic and immune status or concomitant treatments).
Maltese: L-immunoġeniċità tista' tkun influwenzata minn karatteristiċi tal-prodotti (eż. tibdiliet fl-istruttura tal-proteina jistgħu jseħħu matul ħżin jew trasport inadatt, jew il-proteini jistgħu jifformaw aggregati), iżda anki minn fatturi relatti mat-trattament (eż. irriskju jista' jvarja bejn amministrazzjoni taħt il-ġilda u dik intravenuża jew bejn reġimen ta' trattament kontinwu u dak intermittenti) u minn fatturi relatati mal-pazjenti jew mal-mardiet (eż. età, status ġenetiku u immuni jew trattamenti konkomitanti).
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
Maltese: Provi mfassla primarjament biex iqabblu malplaċebo jew ma' standard attwali tat-terapija bl-użu ta' punti ta' tmiem “ibsin” (eż. eżitu fit-tul, mortalità, ħsara strutturali) u popolazzjoni talpazjenti rilevanti biex jintwera l-benefiċċju
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.
Maltese: Fatturi relatati mal-pazjenti (età, status immuni), mard (komorbiditajiet, trattamenti konkomitanti) jew fatturi relatati mat-trattament (rotta tal-amministrazzjoni, tul tal-esponiment) iridu jiġu kkunsidrati wkoll.
English: Pharmacodynamic studies
Maltese: Studji farmakodinamiċi
English: Comparative non-clinical studies Pharmacodynamic
Maltese: Studji mhux kliniċi komparattivi Farmakodinamiċi
English: Healthcare professionals play an essential role in contributing to the understanding of a medicine's safety profile during clinical use.
Maltese: Il-professjonisti fil-kura medika jaqdu rwol essenzjali fil-kontribuzzjoni għall-fehim tal-profil tas-sigurtà ta' mediċina matul l-użu kliniku.
English: Minor variability, e.g. in glycosylation (represented by small blue triangles) may be allowed, while the protein's amino acid sequence (circles) and biological activity are the same.
Maltese: Varjabbiltà minuri, eż. fil-glikosilazzjoni (rappreżentata minn triangoli blu żgħar) tista' tkun permessa, filwaqt li s-sekwenza tal-amminoaċidi tal-proteina (ċrieki) u l-attività bijoloġika huma l-istess.
English: European Medicines Agency: Similar biological medicinal products (overarching guideline).
Maltese: L-Aġenzija Ewropea tal-Mediċini: Similar biological medicinal products (linja gwida globali).
English: Information guide for healthcare professionals
Maltese: Gwida ta' informazzjoni għallprofessjonisti fil-kura medika
English: Immunogenicity data required for approval include incidence, titre and persistence of antibodies against the biological medicine (ADAs), neutralisation assays (because neutralising antibodies may reduce the effect of the medicine), assessment of the clinical impact and measures to manage the potential risk of immunogenicity (e.g. special monitoring of immune-mediated adverse reactions or use of concomitant medication to mitigate infusion reactions).
Maltese: Id-data dwar l-immunoġeniċità meħtieġa għallapprovazzjoni tinkludi l-inċidenza, it-titre u l-persistenza tal-antikorpi kontra l-mediċina bijoloġika (ADAs), l-assaġġi ta' newtralizzazzjoni (għaliex il-korpi newtralizzanti jistgħu jnaqqsu l-effett tal-mediċina), valutazzjoni tal-impatt kliniku u miżuri għall-ġestjoni tar-riskju potenzjali tal-immunoġeniċità (eż. monitoraġġ speċjali tar-reazzjonijiet avversi medjati mis-sistema immunitarja jew l-użu ta' mediċina konkomitanti għall-mitigazzjoni ta' reazzjonijiet għall-infużjoni).
English: Biosimilar Working Party (EMA's working party of EU experts on biosimilars)
Maltese: Grupp ta' Ħidma tal-Bijosimili (grupp ta' ħidma tal-EMA ta' esperti tal-UE dwar ilbijosimili)
English: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2012/06/WC500128688.
Maltese: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/06/WC500128688.pdf.
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').
Maltese: L-indikazzjonijiet tal-mediċina ta' referenza jistgħu jiġu approvati għall-bijosimili fin-nuqqas ta' data klinika speċifika ġġenerata bil-bijosimili (“estrapolazzjoni talindikazzjonijiet”).
English: Most biological medicines are made by biotechnology, often using sophisticated cell systems and recombinant DNA technology.
Maltese: Ħafna mill-mediċini bijoloġiċi huma magħmula bil-bijoteknoloġija, spiss bl-użu ta' sistemi ta' ċelloli sofistikati u teknoloġija tad-DNA rikombinanti.
English: Biological medicines usually cause no or only a limited immune response (e.g. transient appearance of antibodies).
Maltese: Normalment, il-mediċini bijoloġiċi ma jikkaġunaw ebda rispons immuni jew inkella wieħed limitat biss (eż. dehra temporanja ta' antikorpi).
English: Comparative clinical trials to exclude clinically meaningful differences
Maltese: Provi kliniċi komparattivi biex jiġu esklużi differenzi sinifikanti
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.
Maltese: L-Organizzazzjoni Dinjija tas-Saħħa (WHO) żviluppat il-linji gwida tagħha stess għall-bijosimili (imsejħa “prodotti bijoterapewtiċi simili” jew SBPs) u antikorpi monoklonali bijosimili, bl-għan li tipprovdi gwida lillaġenziji regolatorji madwar id-dinja.
English: Conventional clinical trials to demonstrate efficacy and safety in all claimed therapeutic indications
Maltese: Provi kliniċi konvenzjonali għall-wiri tal-effikaċja u tas-sikurezza fl-indikazzjonijiet terapewtiċi ddikjarati kollha
English: Extrapolation
Maltese: Bijosimilarità
English: The black triangle symbol identifies medicines under additional monitoring.
Maltese: Is-simbolu tat-triangolu iswed jidentifika l-mediċini taħt monitoraġġ addizzjonali.
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.
Maltese: għarfien preċedenti tal-immunoġeniċità: għal mediċini bijoloġiċi bi profil talimmunoġeniċità baxx (eż. filgrastim), il-pazjenti normalment jiġu ttestjati għal antikorpi ta' spiss fil-bidu u fi tmiem l-istudju kliniku b'perjodu ta' segwitu iqsar u miżuri ta' farmakoviġilanza ta' rutina għall-ġestjoni ta' kwalunkwe riskju potenzjali.
English: Generally possible to obtain exactly the same molecule
Maltese: Ġeneralment possibbli li tinkiseb l-istess molekula eżatta
English: absolute neutrophil count for biosimilar granulocyte-colony stimulating factor (rather than number of serious infections)
Maltese: għadd assolut tan-newtrofili għall-fattur stimolanti tal-kolonja tal-granuloċiti tal-bijosimili (minflok in-numru ta' infezzjonijiet serji)
English: Polysaccharides Low-molecular weight heparins
Maltese: Polisakkaridi Eparini b'piż molekulari baxx
English: Complexity of the molecule and comparability data available
Maltese: Il-kumplessità tal-molekula u taddata tal-komparabilità disponibbli
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.
Maltese: Jekk il-komparabilità tintwera f'livell strutturali, funzjonali, farmakokinetiku u farmakodinamiku, u l-effikaċja tkun komparabbli, f'dak il-każ jista' jkun mistenni li r-reazzjonijiet avversi dovuti għall-azzjoni farmakoloġika tal-bijosimili jkunu l-istess u li se jseħħu bi frekwenzi simili.
English: EMEA/CHMP/BMWP/42832/2005 Rev. 1. http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2015/01/ WC500180219.pdf.
Maltese: EMEA/ CHMP/ BMWP/101695/2006. http://www.ema. europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003935.pdf.
English: A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (the so-called ‘reference medicine').
Maltese: Bijosimili hi mediċina bijoloġika ferm simili għal mediċina bijoloġika oħra diġà approvata fl-UE (l-hekk imsejħa “mediċina ta' referenza”).
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.
Maltese: Il-komparabilità hi prinċipju xjentifiku ferm stabbilit tax-xjenza regolatorja: studji komparattivi komprensivi talkwalità juru bil-provi li l-karatteristiċi fiżikokimiċi u l-attività bijoloġika huma ferm simili.
English: Full data requirements on pharmaceutical qualityFull data requirements on pharmaceutical quality, plus additional quality studies comparing the structure and biological activity of the biosimilar with the reference medicine
Maltese: Rekwiżiti tad-data sħaħ dwar il-kwalità farmaċewtika, flimkien ma' studji tal-kwalità addizzjonali li jqabblu l-istruttura u l-attività bijoloġika tal-bijosimili mal-mediċina ta' referenza
English: Overview of biosimilar development compared with a reference medicine Biological medicine with new active substance (e.g. reference medicine)
Maltese: Ħarsa ġenerali lejn l-iżvilupp tal-bijosimili mqabbla mal-mediċina ta' referenza Mediċina bijoloġika b'sustanza attiva ġdida (eż. mediċina ta' referenza)
English: This is achieved via comprehensive comparability studies with the reference medicine (figure 5), and on the basis of solid pharmaceutical quality data.
Maltese: Dan jinkiseb permezz ta' studji komprensivi ta' komparabilità mal-mediċina ta' referenza (figura 5), u fuq il-bażi ta' data solida dwar il-kwalità farmaċewtika.
English: The extent of clinical studies needed for approval depends on several factors, including those outlined in table 6.
Maltese: Il-firxa tal-istudji kliniċi meħtieġa għallapprovazzjoni tiddependi minn diversi fatturi, inklużi dawk spjegati fit-tabella 6.
English: Key considerations on potential immunogenicity of biological medicines
Maltese: Kunsiderazzjonijiet importanti dwar l-immunoġeniċità potenzjali talmediċini bijoloġiċi
English: Apart from reactions of an immunological nature, most adverse drug reactions (ADRs) can be predicted from the pharmacological action, and occur with both the reference medicine and the biosimilar (e.g. high haemoglobin levels with epoetins).
Maltese: Apparti mir-reazzjonijiet ta' natura immunoloġika, l-iktar reazzjonijiet avversi tal-mediċina (ADRs) jistgħu jitbassru mill-azzjoni farmakoloġika, u jseħħu kemm bil-mediċina ta' referenza kif ukoll bil-bijosimili (eż. livelli għolja ta' emoglobina b'epotini).
English: number of oocytes retrieved during in vitro fertilisation for biosimilar folliclestimulating hormone (rather than pregnancies or live births)
Maltese: numru ta' ooċiti misjuba matul ilfertilizzazzjoni in vitro għall-ormon follikolu stimulanti tal-bijosimili (minflok in-numru ta' nisa tqal jew ta' twelid ħaj)
English: The EU legislation imposes strict requirements for the manufacture of all medicines:
Maltese: Il-leġiżlazzjoni tal-UE timponi rekwiżiti stretti għall-manifattura talmediċini kollha:
English: A biosimilar medicine (‘biosimilar') is a medicine highly similar to another biological medicine already marketed in the EU (the so-called ‘reference medicine')
Maltese: Mediċina bijosimili (“bijosimili”) hi mediċina ferm simili għal mediċina bijoloġika oħra diġà mqiegħda fis-suq fl-UE (l-hekk imsejħa “mediċina ta' referenza”)1,2.
English: Demonstration of high similarity to a reference biological medicine in terms of chemical structure, biological activity and efficacy, safety and immunogenicity profile, mainly based on comprehensive comparability studies.
Maltese: Il-wiri ta' similarità għolja għal mediċina bijoloġika ta' referenza f'termini tal-istruttura kimika, tal-attività bijoloġika u tal-profil tal-effikaċja, tassikurezza u tal-immunoġeniċità, l-iktar fuq il-bażi ta' studji komprensivi ta' komparabilità.
English: Traceability: importance of identifying biological medicines by tradename and batch number
Maltese: Traċċabilità: l-importanza li l-mediċini bijoloġiċi jiġu identifikati mill-isem kummerċjali u minnumru tal-lott
English: [Brand name] is a biosimilar medicinal product.
Maltese: [Isem kummerċjali] hu prodott mediċinali bijoloġiku simili.
English: CHMP/437/04 Rev. 1. http://www.ema.europa.
Maltese: CHMP/437/04