Browsing by Subject "biosimilaari"

Biological medicines are used, for example, in the treatment of diabetes, cancer, and autoimmune diseases. Biological medicines cause a significant part of the costs of prescription drugs in outpatient care. In Finland, automatic substitution of biological medicines will be introduced in 2024–2025 to promote the use of biosimilars and to increase price competition. When substituting biological medicines, pharmacists are required to counsel the customer and ensure proper use of the new administration device. The objective of this study was to study Finnish community pharmacists’ knowledge about biological medicines and biosimilars and the need for further training. Data was collected with an electronic questionnaire and analyzed using frequencies and percentages. Associations between background variables and readiness for automatic substitution were analyzed using crosstabulation and chi-squared test. Differences in drug-specific knowledge were compared using sum variables. Most pharmacists (n=899) answered that they understood at least the basics of what biological medicines and biosimilars are. The important role of biosimilars in reducing society's drug costs seemed to be well understood, but only one in four (25.0%) felt that they were ready for automatic substitution. Master’s degree in pharmacy, graduating as a pharmacist (BSc) between 2010 and 2022, and working in community pharmacy for less than 10 years after graduating as pharmacist (BSc) increased the experience of readiness for automatic substitution. Previous work in the pharmaceutical industry or wholesale trade, in official positions or in research and teaching positions also increased the experience of readiness for automatic substitution, as well as clinical expertise or additional training in the field of pharmacy. Drug-specific knowledge seemed to be best about enoxaparin and insulins. Further training was needed especially on the differences of administration devices and giving injection advice. The strength of this study was a representative sample of pharmaceutical personnel working in Finnish community pharmacies, although low response rate weakens generalizability of the results. The results give an indication of how Finnish community pharmacists assessed their knowledge about biological medicines and biosimilars before the introduction of automatic substitution in Finland. Further research is needed to monitor the development of knowledge about biological medicines and to examine customers’ experience on the quality of medication counselling related to biological medicines at pharmacies.

This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.

The price competition of biological medicines induced by biosimilars has started slower than expected in Europe. One of the main reasons has been the differences in physicians’ attitudes toward biosimilars. Switching biological medicines to clinically comparable alternatives is an important way to enhance the cost-effectiveness of using biological medicines. The focus of the conversation has shifted from the general similarity of biosimilars and the originators to whether frequent switching involves additional risks. The purpose of this master’s thesis was to investigate factors influencing physicians’ prescribing of biological medicines. In addition, their perceptions of the automatic substitution of biological medicines in Finland were explored. The study was based on structured personal interviews of rheumatologists and gastroenterologists including specialising physicians who work at HUS Helsinki University Hospital in the Hospital District of Helsinki and Uusimaa (n=48). They had a chance to comment on their responses at any time freely. The interview consisted of four sections: demographics, general attitudes toward biosimilars, factors affecting prescribing biological medicines, and perceptions of the automatic substitution of biological medicines. Study participants had a chance to comment on their structured responses during the interview. The interviews were recorded for further analysis of the comments. The results are based on a descriptive quantitative analysis and an inductive analysis of the comments. The interviewed physicians’ (n=27, response rate 56,3%) attitudes toward biosimilars were highly positive. Most of the physicians (21/27, 78%) also strive to motivate patients to switch biological medicines to clinically comparable but lower-cost options despite the challenges associated with switching, for example the differences in the administration devices. Of the previously determined factors, the ones affecting prescribing biological medicines the most were the willingness to support the price competition between the biological medicines, reimbursement status, and the hospital’s drug formulary when initiating the biological treatment in the hospital. The attitudes toward the automatic substitution of the biological medicines were positive among 13/27 (48 %) physicians. Our study results are in line with the results of earlier studies, but the open responses especially to the automatic substitution of biological medicines might indicate more positive perceptions on the subject among physicians in Finland.

Finland is one of the first countries in the world to introduce automatic substitution of biological medicines in community pharmacies. The automatic substitution for biological medicines will be introduced in stages in years 2024–2026. The successful and safe transition requires guidelines for implementing new operating practices and dispensing practices, including possible continuing education to community pharmacists to ensure their sufficient competence e.g. in advising patient how to use their administration devices. Therefore, the change process requires competence development and management. The purpose of competence management is to create, maintain and develop an organization. Competence management is part of strategic personnel management, which ensures that the organization has the core competence and other necessary competence to implement its mission. The aim of this master's thesis was to study the competence management while preparing for the automatic substitution of biologics in community pharmacies in Finland. The research focused on the competence management practices and competence development needs within the framework of 1) personnel management and competence development and 2) automatic substitution of biologics. The research was carried out as a qualitative focus group discussions (FGDs) (n = 6, altogether of 23 participants) in January 2023. Voluntary participant participated in the group discussions from community pharmacies of different sizes and from different parts of Finland. Of the participants there were pharmacy owners with M.Sc. (Pharm) degree (n = 5/23, 22 %), pharmacists with M.Sc. (Pharm) degree (n = 10/23, 43 %) and pharmacists with B.Sc. (Pharm) degree (n = 8/23, 35 %). Qualitative content analysis was carried out inductively, i.e. data oriented. In addition to the themes emerging from the research material, the main themes of the discussion body partially guided the analysis. SRQR checklist was used to support detailed reporting to evaluate the reliability of the study. The data analysis identified 1) factors related to the current practices and needs of competence management and needs for competence development, 2) methods applicable for competence development of pharmaceutical personnel, and 3) functions related to the delivery of the biological medicine, such as medication counselling, support for the patient's self-care and a possible substitution of biologics, as well as the functions and tools that support these. The results of this study indicated that competence management practices vary between community pharmacies, and the competence management actions were not always systematically planned. Community pharmacies did not yet have operating models or practices for implementing automatic substitution of biologics, although they perceived that automatic substitution practices for inhalable medicinal products could perform as a model for the substitution of biologics. Despite some perceived uncertainties concerning implementation of automatic substitution of biologics, community pharmacists and pharmacy owners had mainly positive attitude towards the coming changes.

Biologisten lääkkeiden tarjonta ja käyttö ovat lisääntyneet voimakkaasti viimeisen vuosikymmenen aikana. Biologiset lääkkeet voivat parantaa reumasairauksien ja useiden muiden pitkäaikaissairauksien hoitotuloksia. Biologiset lääkkeet ovat yleensä perinteisiä pienimolekyylisiä lääkkeitä kalliimpia, ja siksi biologisen alkuperäislääkkeen kanssa kliinisesti samanarvoiseksi kehitettyjen edullisempien biosimilaarien käyttöä pyritään edistämään osana rationaalista lääkehoitoa. Potilaan näkemyksillä ja niiden huomioimisella on hoitoon sitoutumisen ja hoidon tulosten kannalta suuri merkitys. Potilaiden näkemyksistä ja kokemuksista biologisista lääkkeistä ja niiden vaihdosta on melko vähän tutkimuksia. Tutkimuksen tavoitteena oli tutkia reumapotilaiden tietämystä ja näkemyksiä biologisista lääkkeistä ja biosimilaareista sekä kokemuksia niiden ei-lääketieteellisestä lääkevaihdosta. Lisäksi tutkittiin reumapotilaiden uskomuksia omasta lääkityksestään, halukkuutta osallistua lääkitykseen liittyvään päätöksentekoon lääkärin kanssa ja biologisten reumalääkkeiden käyttäjien lääketiedon lähteitä. Tutkimus toteutettiin sähköisenä kyselynä Yliopiston Apteekin kanta-asiakkaille ja kertomalla siitä Reumaliiton ja IBD- ja muut suolistosairaudet ry:n viestinnässä 18.–30.1.2021. Kohderyhmänä olivat aikuiset avoterveydenhuollon reuma-, IBD- ja muut suolistosairaus-, sekä ihopsoriasispotilaat, jotka käyttivät adalimumabin tai etanerseptin alkuperäistä biologista lääkettä (BA) tai biosimilaaria (BS) tai ainoastaan perinteisiä pienimolekyylisiä lääkeitä (PL). Tässä tutkimuksessa tarkasteltiin vastauksia 260 reumapotilaalta, joista biologisia lääkkeitä oli käyttänyt 75 (BA-käyttäjiä 35, BS-käyttäjiä 40) ja perinteisiä lääkkeitä 185. Ei-lääketieteellisen lääkevaihdon kokeneita oli 17. Tutkimuksen teoreettisena viitekehyksenä käytettiin terveysuskomusmallia. Ensisijaiset lopputulosmuuttujat olivat faktorianalyysillä muodostettuja summamuuttujia. Erot lääkekäyttäjäryhmien (BA, BS, PL) välillä ja taustamuuttujien vaikutukset testattiin tilastollisilla analyyseillä. Vastanneista potilaista 94 % tunnisti biologisen lääkkeen käsitteen, mutta biosimilaari-käsite tunnettiin huonommin (34 %). Suurin osa potilaista (73–78 %) luotti biosimilaarien olevan ominaisuuksiltaan samankaltaisia alkuperäisvalmisteiden kanssa. Lääkärin tekemään biologisten lääkkeiden vaihtoon luotettiin enemmän (89 %) kuin mahdollisesti apteekissa tehtävään vaihtoon (40 %). Tutkimuksessa todetut kokemukset biologisten lääkkeiden vaihdosta biosimilaariin olivat pääosin positiivisia. Tutkimuksen reumapotilailla oli hyvä tietämys biologisista lääkkeistä, mutta he tunsivat huonommin biosimilaarin käsitteen ja mitä biosimilaarit ovat. Heillä oli yleisesti ottaen luottavainen näkemys siitä, että biosimilaari on ominaisuuksiltaan alkuperäisvalmistetta vastaava lääke. Biologisten ei-lääketieteelliseen vaihtoon suhtauduttiin melko myönteisesti, mutta lääkärin toteuttamaan lääkevaihtoon suhtauduttiin luottavaisemmin kuin mahdollisesti apteekeissa tehtävään vaihtoon. Lisää tutkimustietoa tarvitaan muun muassa potilaiden biosimilaareihin kohdistuvan epävarmuuden syistä.

Biologiset lääkkeet ovat keskeinen osa syöpäsairauksien hoitoa. Ne ovat usein perinteisiä pienimolekyylisiä lääkkeitä kalliimpia, ja niiden aiheuttamia kustannuksia potilaalle ja yhteiskunnalle voidaan hillitä edullisempien biosimilaarien eli vertailukelpoisten biologisten lääkkeiden käytöllä. Tutkimuksen tavoitteena oli tutkia kyselyaineiston perusteella syöpäpotilaiden näkemyksiä lääkärin toteuttamasta biologisten lääkkeiden lääkevaihdosta ja niihin vaikuttavia tekijöitä avoterveydenhuollossa. Lisäksi tutkittiin, miten yleisesti syöpäpotilaat tunnistavat biologisen lääkkeen ja biosimilaarin käsitteet, ja potilaiden syöpälääkitystään koskevia lääketiedon lähteitä. Tutkimuksen osana toteutettiin järjestelmälliseen kirjallisuushakuun perustuva katsaus syöpäpotilaiden näkemyksistä biologisista lääkkeistä ja/tai biosimilaareista ja niiden lääkevaihdosta. Tutkimus perustui Yliopiston Apteekin ja Helsingin yliopiston yhteistyössä Suomen Syöpäpotilaat ry:n kanssa toteuttamaan tutkimuskyselyyn syöpäpotilaille tammikuussa 2021. Tutkimuskutsu lähetettiin Yliopiston Apteekin kanta-asiakkaille tutkimusuutiskirjeenä ja Suomen Syöpäpotilaat ry tiedotti tutkimuksesta sähköisessä viestinnässään. Tutkimuksen kohderyhmänä olivat aikuiset, joilla oli lääkärin toteama syöpäsairaus ja jotka olivat käyttäneet syöpäsairautensa hoitoon lääkärin määräämä lääkehoitoa kyselyä edeltävän 12 kuukauden aikana. Tutkimusaineisto koostui 294 kohderyhmän potilaasta. Ensisijaisella tulosmuuttujalla (summamuuttuja) tutkittiin syöpäpotilaiden näkemyksiä lääkärin toteuttamasta biologisten lääkkeiden lääkevaihdosta. Vastaajilla oli keskimäärin myönteinen näkemys lääkärin toteuttamasta biologisten lääkkeiden lääkevaihdosta, mutta lääkevaihdon toteuttamiseen liittyi potilaiden kokemaa epävarmuutta (summamuuttuja: Cronbachin alfa 0,808; keskiarvo 3,29/5,00, 95 % lv 3,20–3,38). Myönteinen näkemys oli yhteydessä potilaiden myönteisiin näkemyksiin biosimilaarien ja geneeristen lääkkeiden ominaisuuksista, kuten tehosta, haittavaikutuksista ja käytettävyydestä sekä vastaajan korkeampaan koulutustasoon ja vähäisempiin huoliin yleisesti omasta lääkehoidostaan. Enemmistö (72 %) vastaajista tunnisti biologisen lääkkeen käsitteen, biosimilaari-käsite tunnistettiin heikommin (19 %). Vastaajien käytetyimmät lääketiedon lähteet syöpälääkityksestään olivat terveydenhuollon ammattilaiset (48–88 %) ja pakkausseloste (80 %). Syöpäpotilaiden näkemyksiin biologisten lääkkeiden lääkärin toteuttamasta lääkevaihdosta vaikuttivat useat tekijät, kuten näkemykset biosimilaarien ja geneeristen lääkkeiden ominaisuuksista. Vaikka useat syöpäpotilaat suhtautuivat keskimäärin myönteisesti lääkärin toteuttamaan biologisten lääkkeiden lääkevaihtoon, siihen liittyi usein epävarmuutta. Tulevaisuudessa tulisi tutkia tarkemmin syöpäpotilaiden tietämystä biologisista lääkkeistä ja biosimilaareista. Lisäksi tulisi tutkia millaista lääkeinformaatiota potilaat tarvitsevat päätöksenteon tueksi biologisten lääkkeiden lääkevaihdossa.

For their good clinical value and supply the use of biological medicines has increased in the treatment of inflammatory bowel disease (IBD). However, biological medicines are often more expensive compared to traditional small molecule medicines. More inexpensive biosimilars, shown to be clinically equal to the corresponding biological original products, can be used to reduce medication costs as part of rational pharmacotherapy. Although patients’ perceptions about biosimilars may affect the treatment adherence and outcomes of the use of these medicines, only a few studies have been published on this area. The primary aim of the study was to study IBD patients’ perceptions of the features of biosimilars and biosimilars’ suitability for their own treatment. The secondary aim was to study biological medicine users’ perceptions of the suitability of biosimilar switch by a physician for their own treatment. In addition, sources of medicines information of the users of biological medicines were studied. The data of the study were based on a cross-sectional survey conducted by the University Pharmacy and University of Helsinki in January 2021. Research Newsletter and response link were delivered per an email to University Pharmacy’s loyal customers and electronically communicated via the Association of Rheumatism and the Association of IBD and other intestinal diseases. The study comprised of the responses of adult outpatients with IBD (n=979) who were using original biological medicines (n=120), biosimilars (n=30) or traditional small molecule medicines (n=829) (medicine user groups). The sum variables constructed by factor analysis based on the study aims were used as outcome variables. Differences between medicine user groups and the effects of other background variables were analyzed by bivariate and multivariate analysis using SPSS Statistics software. Most of the patients (70–97 % depending on the medicine user group) trusted biosimilars’ features to be equal to the corresponding original biological medicines. However, more than half of the patients (53–67%) did not know whether they would like to physician to prescribe biosimilar to them rather than the original biological medicine. Of the users of original biological medicines, 71 % did not want to be switched to a biosimilar if the current medication was working well. Biosimilar users had more positive perceptions about biosimilars and switching compared to other medicine user groups. Physician’s perception played an important role in biologic switching. Several factors that may affect perceptions about the features of biosimilars and their use in patient’s own treatment were identified. These included, in particular, previous user experience with biosimilars and having information about them. Overall, patients had positive perceptions about the features of biosimilars but had uncertainties about the use of biosimilars, especially, for the treatment of their own disease and when switching medication. More research is needed on the perceptions among different patient groups, and on the need and optimal form of medication information on biological medicines, biosimilars and their switching.