Biosimilar Medicines Research Articles

Potential for biosimilars in rheumatology in Africa

Biosimilars are products which are highly similar to a reference biologic product (RBP). In Africa, regulatory frameworks for biosimilar approval are still in development in many countries and few biosimilars...

The impact of policy interventions to promote the uptake of biosimilar medicines in Belgium: a nationwide interrupted time series analysis

BackgroundThe Belgian government has taken several measures to increase the uptake of biosimilars in past years. However, no formal evaluation of the impact of these measures has been made yet. This study aimed to investigate the impact of the implemented measures on biosimilar uptake.MethodsAn interrupted time series analysis was performed using an autoregressive integrated moving average (ARIMA) model with the Box-Jenkins method. All data were expressed as defined daily doses (DDD) per month/quarter and obtained from the Belgian National Institute for Health and Disability Insurance (NIHDI). Three molecules were included in the analysis: etanercept (ambulatory), filgrastim (hospital), and epoetin (hospital). A significance level of 5% was used for all analyses.ResultsIn the ambulatory care, the effect of a financial prescriber incentive of 2019 was investigated. After this intervention, 44.504 (95% CI −61.61 to −14.812; P < 0.001) fewer etanercept biosimilar DDDs were dispensed monthly than expected in the absence of the intervention. Two interventions were modelled for biosimilars in the hospital setting. The first intervention of 2016 includes prescription targets for biosimilars and monitoring of hospitals on adequate tendering. The second intervention involves an information campaign on biosimilars. After the first intervention, a small decrease in quarterly epoetin biosimilar uptake of 449.820 DDD (95% CI −880.113 to −19.527; P = 0.05) was observed. The second intervention led to a larger increase in quarterly epoetin biosimilar uptake of 2733.692 DDD (95% CI 1648.648–3818.736; P < 0.001). For filgrastim, 1809.833 DDD (95% CI 1354.797–2264.869; P < 0.001) more biosimilars were dispensed immediately after the first intervention and 151.639 DDD (95% CI −203.128 to −100.150; P < 0.001) fewer biosimilars each quarter after the first intervention. An immediate and sustained increase of 700.932 DDD (95% CI 180.536–1221.328; P = 0.016) in quarterly biosimilar volume was observed after the second intervention. All other parameter estimates were not statistically significant.ConclusionsThe results of this study suggest that the impact of past policy interventions to increase the uptake of biosimilars has been variable and limited. A holistic policy framework is required to develop a competitive and sustainable off-patent biologicals market in Belgium.

Biosimilars in dermatology: identifying myths and knowledge gaps.

Biosimilars are beginning to gain regulatory approval in the United States. Biosimilars are structurally near identical to the innovator and must demonstrate identical pharmacokinetics via the same binding affinity and biological function on assays. However, biologics are so complex that even the innovator company cannot produce exact duplicates; there is batch-to-batch variation. The International Psoriasis Council has outlined a biosimilarity index, which aims to standardize preclinical definitions of biosimilarity. Such an index, paired with post-approval monitoring, could provide a transparent, quantitative definition of biosimilarity. Such an index could increase trust in biosimilar medicines and the preclinical assessment process without increasing costs. As preclinical analyses are critical to biosimilar approval, manufacturers should devote proportionate resources to completing them. Dermatologists, who might reflexively look for indication-specific clinical data, might also shift their focus to preclinical variables. Finally, it should be noted that biosimilars provide more evidence of similarity than we have for different batches of the innovator product. Thus, any clinical testing standards, or lack thereof, for different batches of innovator products should also apply to biosimilars.

Knowledge and attitude of community pharmacists toward biosimilar medicines: A cross-sectional study in Lebanon

ObjectivesPharmacists are drug experts who can play a significant role in promoting the use of biosimilar medicines. Therefore, the aim of this study was to assess community pharmacists' knowledge and attitude toward biosimilars in Lebanon, as well as potential factors influencing their knowledge. MethodsA descriptive, cross-sectional study involving licensed community pharmacists in Lebanon was conducted using random sampling between January and July 2022. An electronic survey consisting of 30-closed ended questions was used, it included 10 questions to assess participants knowledge towards biosimilars and 10 attitudinal statements. A knowledge score was then calculated. A multivariable analysis was conducted to determine predictors of knowledge using binary logistic regression including all variables with p < 0.20 on univariate analysis. Statistical significance was set at p value < 0.05. Key findingsIn total, 354 community pharmacists completed this survey. The majority of participants 261 (73.7%) were knowledgeable, with only 54 (15.3%) answering all the questions correctly. The results of the multivariable analysis showed only a statistically significant association between knowledge and pharmacists who had taken a course or post-graduate training course about biosimilar drugs (OR = 2.213, 95% CI = 1.088–4.500, p-value = 0.028). The majority of pharmacists 314 (88.7%) agreed with the statement “Healthcare professionals should be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice.” ConclusionsOverall, community pharmacists in Lebanon had a good knowledge about biosimilars that was significantly associated with post-graduate training courses. Additionally, our participants had a generally favorable attitude toward biosimilars.

An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain.

The availability of biosimilar medicines in Southern European markets has allowed purchasing biologics at a lower cost for healthcare systems. However, the capacity to seize this cost-reduction opportunity in the long run depends on fostering a sustainable competitive environment for all the market players involved. Diverse policies and information campaigns have been launched in Italy, Portugal and Spain to support uptake of "best-value" biologics (BVB). Despite these measures, the utilization of lower-cost biologics in certain regions is low, especially when it comes to the treatment of chronic conditions. We aim to identify biosimilar uptake determinants in hospital environments in Italy, Portugal and Spain, using the class of TNF-alpha inhibitors as an example. This is a mixed-methods study based on (1) the quantitative analysis of regional uptake data for TNF-alpha inhibitor biosimilars and (2) the qualitative processing of semi-structured interviews capturing experts' views on uptake determinants for biosimilars. The organization of multi-stakeholder information campaigns supporting TNF-alpha inhibitor biosimilars use in Italy, Portugal and Spain has resulted in an increased familiarity of healthcare professionals and patients with the prescription/use of these products. However, barriers persist that impede high biosimilars uptake, especially in chronic patient populations eligible for a switch. These are: (1) the late publication of position statements on biosimilars interchangeability by regulatory health authorities; (2) the vague positioning of (national/regional) health authorities on best switching practices (including multiple biosimilar-to-biosimilar switches); (3) the existence of policy frameworks that do not necessarily support the initiation of switching protocols; (4) the establishment of sometimes inefficient purchasing procedures that limit biosimilars potential to compete for market shares. Diverse approaches taken regionally to address these barriers have contributed to heterogeneous TNF-alpha inhibitor biosimilars uptake across Southern Europe. Our research signaled the limited reach of biosimilar policies implemented locally, if not supported by a national policy framework. This study highlights the need for the coordinated implementation of policy measures fostering biosimilars use at the regional and national level in Italy, Portugal and Spain. These measures should account for the particularities of off-patent biologic and biosimilar markets and should jointly address supply- and demand-side challenges.

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis.

Background: The level of competition achieved following biosimilars market availability varies by country, care setting and molecule. Hence, biosimilars contribution to attaining price reductions and extended access to treatments can also vary. Objective: The aim of this study is to capture market dynamics for tumor necrosis factor (TNF)-alpha inhibitors and competing molecules in Southern European markets (2011-2020), and to evaluate the benefits of the competition generated by the availability of biosimilars. Methods: This study is based on a literature review examining market characteristics for TNF-alfa inhibitors and competing immunomodulator molecules, and on the quantitative analysis of market data for these molecules in Italy, Portugal and Spain. Results: Following biosimilars availability in Italian, Portuguese and Spanish markets, there has been an expansion in the overall access to TNF-alfa inhibitor pharmaceuticals. Further, savings have been generated within the TNF-alfa inhibitors class even after the increased use of these molecules. However, the potential of infliximab, etanercept and adalimumab biosimilars to generate price competition outside of their own drug class appeared limited in the studied markets. Considering this limitation and that shifts towards on-patent and higher-cost therapies have occurred after TNF-alfa inhibitor biosimilars availability, the importance of investing in biosimilars development for still on-patent immunology biologics is emphasized. Conclusion: This study highlights the need for policies that do not only seek higher utilization of biosimilars, but that also support a sustainable market for these products. This is expected to foster the future development of biosimilar medicines.

PP18 Horizon Scanning For Clinical Biosimilar Medicines: Informing The Lifecycle Of Health Technology Assessment And Market Access

IntroductionThe National Institute for Health and Care Research (NIHR) Innovation Observatory (IO) national horizon scanning research centre, has a remit to notify its stakeholders, including the National Institute for Health and Care Excellence (NICE), about innovative interventions; including biosimilar medicines in the pipeline. Biosimilar medicines bypass many developmental steps, making them substantially cheaper to manufacture for providers, which increases market availability and improves treatment access for patients.MethodsSince 2017, the NIHR IO has monitored biosimilars in clinical development that align to the NICE health technology assessment remit. The data set explored was exported from our internal medicines innovation database - MInD.Data sets were created that included information on the characteristics of biosimilars and their associated clinical trials. Analyses and visualization creation were carried out using Microsoft Excel and Microsoft Power BI.ResultsA total of 100 unique biosimilar medicines in 136 clinical trials were included in the MInD since April 2017. Of these, 44 percent of biosimilars are currently EMA-approved (Nov 2021). Adalimumab was the reference medicine with the most unique biosimilars identified (12%). Seventy-two percent of the biosimilars in MInD were indicated for non-oncology conditions, twenty percent for oncology condition and eight percent for both.There were 46 biosimilars unapproved, which were in active development. Of these biosimilars 17.4 percent are indicated for an oncology condition, 78.3 percent for non-oncology conditions, and 4.3 percent for biosimilars for both. Aflibercept was the reference product with the most (eight) biosimilars in active development.There were 56 individual clinical trials in the MInD that list a biosimilar in development. For 26 trials, the primary completion date (PCD) was prior to 2021, whilst 28 trials listed a PCD post-2021, and 2 PCD’s were unavailableConclusionsOur analysis identified high levels of active clinical development for biosimilars. The majority of biosimilars being developed are indicated for non-oncology conditions, with many in trials due to readout in the near future. Early identification, monitoring and reporting of biosimilars allows for expedited patient access and benefits, including cost-savings for health services.This study is funded by the National Institute for Health Research (NIHR) [(HSRIC-2016-10009)/Innovation Observatory].

Biosimilars of anti‐vascular endothelial growth factors for ophthalmic disease – Clinical trial status 2022

AbstractPurpose: Diabetic Macular Œdema (DME) and Age‐related Macular Degeneration (nAMD) are the leading causes of vision loss in developed nations. Anti‐Vascular Endothelial Growth Factor (aVEGF) has revolutionized the treatment of both conditions, but access is limited by costs. Biosimilars of aVEGF can cut costs, but prescriber concerns over the lack of clinical data can slow uptake. This paper reports all biosimilar aVEGF in development for Europe and the USA, and pools the results of clinical confirmatory trials to provide statistically greater reassurance in the similarity of outcomes.Methods: Biosimilars in the clinical development phase were identified from US and EU trial registries.Results: There are 13 biosimilars of ranibizumab and aflibercept in final clinical comparative trial stage of development in Europe and the USA, recruiting 6126 patients. Five studies of intravitreal bevacizumab biosimilars are recruiting 772 patients. Equivalence outcomes are typically based on Best‐Corrected Visual Acuity (BCVA) with 90% confidence limits of −3 to +3 letters between reference and biosimilar medicines. Completed trials to date with 1166 participants analysed together show BCVA outcomes of ≤1 letter between Originator Reference Products and Biosimilars; for serious adverse events the risk ratio is 1.17, with 95% confidence intervals of 0.85–1.63, p = 0.32.Conclusions: Biosimilars of aVEGF are expected soon. There are likely sufficient brands expected to create meaningful price competition. To date, the EU/US regulatory pathway is delivering biosimilars with close equivalence of safety and efficacy outcomes.

HPR116 The Impact of Policy Measures to Increase the Uptake of Biosimilar Medicines in Belgium: A Nationwide Interrupted Time Series Analysis

HPR116 The Impact of Policy Measures to Increase the Uptake of Biosimilar Medicines in Belgium: A Nationwide Interrupted Time Series Analysis

Sandoz boosts Austria antibiotics

Sandoz says it will invest $50 million to expand production capacity for finished-dosage penicillin at its plant in Kundl, Austria. The company, a leading supplier of generic and biosimilar medicines, last year announced a $100 million investment in the site to manufacture the active pharmaceutical ingredient (API) in oral amoxicillin. The investments are part of Sandoz’s $250 million expansion in antibiotics manufacturing at its European sites, including a $50 million project unveiled in 2021 to bolster sterile API production in Palafolls, Spain.

Prices of new medicines: International analysis and policy options

Equitable and sustainable access to medicines is a global challenge, including for high-income countries. Over the last two decades, launch prices of new medicines have considerably increased, making some medicines unaffordable for many countries. This article is based on a presentation held by the author at the IQWiG Autumn Symposium in November 2021. The medicine price situation in European countries and beyond is presented informed by international evidence. Medicine prices vary across countries, and for some therapeutic groups (e.g., cancer drugs) medicines are largely unaffordable and/or unsustainable for most countries. Selected policy options to improve affordability, which are commonly applied and considered as potential solutions, are discussed. The article stresses the importance of price regulation, and of transparency of prices and further components across the pharmaceutical value chain. Many governments opted for concluding managed-entry agreements (e.g., pay-for-performance) with confidential discounts to make new medicines with high price tags affordable and/or to manage uncertainty about their performance. However, this policy is linked to limitations, particularly due to its secrecy of discounts. Patent expiry of biological medicines can contribute to affordable access; however, it is important to strategically exploit the biosimilar potential by implementing a mix of appropriate policies to foster competition and enhance the uptake of biosimilar medicines.

The systematic evaluation of biosimilar medicine studies for the last five years in the world, and the outcomes

Amaç: Faz 1 çalışmalar aday ilacın ilk defa insan ile karşılaştığı çalışmalar olması nedeni ile önemlidir. Ülkemizde yazım tarihi itibari ile 12 adet onaylı Faz 1 merkezi bulunmaktadır. Biyoteknolojik ilaçlar tüm dünyada başarı göstermelerin yanı sıra çok ciddi bir tedavi maliyetine neden olabilmektedirler. Patent koruma sürelerinin sonlanması ile biyobenzer ilaçlar aynı pazarda yer bularak hem tedavi maliyetlerinde azalmaya hem de daha fazla kişinin ilacı ulaşabilmesine sonuç vermektedir. Gereç ve Yöntem: Bu yazıda 01.01.2017-01.06.2022 yıllarında dünyada biyobenzer ilaçlar ile yapılmış olan Faz 1, Faz 1, Faz 1-2 klinik çalışmaların sistematik değerlendirilmesi yapılmıştır. Son 65 aya ait olan bu veriler başvuru sayıları, çalışma süreleri, gönüllü sayıları ve sağlıklı gönüllü sayıları açısından ilişkilendirilerek değerlendirilmiştir. Bulgular: 01.01.2017-01.06.2022 tarihleri arasında toplamda kayıtlı 87 biyobenzer çalışmasında 7746 gönüllü ile çalışılmıştır. Bu gönüllülerin 4906’sı (%76,08) sağlıklı gönüllülerden oluşmaktadır. Tamamlanmış olan çalışmaların ortalama süresi 293,2 gün ve bu çalışmalara ait ortalama gönüllü sayısı 155,6’dır. Sonuç: Sonuç olarak, biyobenzer ürünler ile yapılan karşılaştırmalı Faz 1 çalışmalar yüksek sayıda sağlıklı gönüllü katılımı gerektirebilen, uzun süreli, her basamağının detaylı olarak planlanması gereken çalışmalardır. Patent sürelerinin sonlanması önümüzdeki dönemde biyobenzer çalışmaları için yeni merkezlerin aranması ihtiyacını doğuracaktır.

Medicines for Europe - 16th Legal Affairs Conference (June 29-July 1, 2022 - Barcelona, Spain).

Medicines for Europe held its 2022 annual conference in Sitges, Spain, from June 29 to July 1. Many topics were discussed including future-proofing healthcare systems in the E.U., methods to build a sustainable European ecosystem to incentivize the development of value-added medicines (VAMs), how to reshape national market policies and build a strong European co-operation to prevent shortages. In addition, attendants discussed key challenges and barriers that need to be addressed to ensure the E.U. remains a leader and an innovator in medicines manufacturing, as well as national strategies and practices influencing the sustainability of the biosimilar medicines market and patient access to biological medicines.

Availability of New Medicines in the US and Germany From 2004 to 2018

Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial availability of medicines. To examine differences in the timing and scope of new medicines available in Germany and the US. This retrospective cohort study analyzed initial availability of new medicines approved by regulatory agencies in Germany and the US between January 1, 2004, and December 31, 2018, and followed up through December 31, 2019. Data analysis was conducted from January 1, 2020, to July 1, 2022. A total of 599 novel approvals were reviewed. Generic, biosimilar, vaccine, and combination medicines were excluded. US Food and Drug Administration approvals were reviewed for therapies categorized as new molecular entities or new active ingredients. German approvals were reviewed from secondary administrative data of authorized medicines that determine availability in Germany, including data presented by the European Medicines Agency. Approvals were analyzed to determine the percentage of medicines approved and available in the US, Germany, or both countries and compare the times to reach the market. Analysis of 599 new medicines demonstrated that fewer were available in Germany compared with the US (80% vs 92% of all potential therapies) and that the median difference in time to market was 4 months (95% CI, -44.40 to 44.76 months). Forty-nine medicines were approved in Germany but not in the US, 75% of which were rejected by the US Food and Drug Administration, were withdrawn, or had US equivalent agents. In this cohort study, fewer new medicines were available in Germany compared with the US between 2004 and 2018. In addition, drugs entered the German market later than in the US.

Nurses' Knowledge and Attitudes towards Biosimilar Medicines as Part of Evidence-Based Nursing Practice-International Pilot Study within the Project Biosimilars Nurses Guide Version 2.0.

Introduction: The increasing availability of biosimilars can increase patient access to these drugs and reduce the economic burden. Nurses play a key role in the education, administration, pharmacovigilance and management of the side effects of biosimilars. The aim of this study was to assess the knowledge and attitudes of nurses towards biosimilar drugs in different countries. Methods: An international cross-sectional study was conducted from November 2021 to February 2022. The survey was carried out using Computer-Assisted Web Interview (CAWI), sent by the CAWI panel via the website. Results: The results showed that nurses with a greater level of education felt most knowledgeable about biosimilars (χ2 = 105.813, df = 2, p < 0.001). One-third of nurses with a doctorate and a second degree said biosimilars are used in their workplace (χ2 = 48.169, df = 4, p < 0.001); most nurses with a second degree said that they had never heard of biosimilars (41%). Doctorate-level nurses thought knowledge is the key factor to increasing biosimilar uptake (97%). Conclusions: Nurses are not knowledgeable about biosimilars. Most would like to participate in training on biosimilars. This is a very important topic, because biosimilars are constantly evolving in medicine.

The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease.

Despite growing awareness of the nocebo effect, few studies have evaluated the nocebo effect using combined assessment of patient-reported outcome measures (PROMs), clinical indices, and objective biomarkers in inflammatory bowel disease (IBD) patients switching from originator to biosimilar medicines. This study aimed to compare these outcomes across switch and non-switch cohorts to evaluate the nocebo effect in patients with IBD. Parallel cohorts of IBD patients who (1) switched from originator to biosimilar (CT-P13) infliximab and (2) continued biosimilar (CT-P13) infliximab were evaluated over 32 weeks. Clinical disease activity, objective biomarkers and PROMs were assessed at baseline, and weeks 16 and 32 across both cohorts. The PROM of interest was patient-perceived disease activity evaluated using a 0-100 visual analogue scale (VAS) per the IBD-Control Questionnaire. Of 81 patients, 47 switched from originator to biosimilar (CT-P13) infliximab. A negative change from baseline patient-reported disease control was observed across the switch cohort compared with the non-switch cohort at week 16 (mean VAS - 8.21 vs. 1.26; p=0.03), but not at week 32 (mean VAS - 1.21 vs. 1.38; p=0.58). Corresponding clinical and objective biomarker assessments over these timepoints were comparable across both cohorts. This study demonstrated a temporary yet discernible nocebo effect in the first 16 weeks following non-medical switching that was not sustained at week 32. Negative patient perceptions may be overcome by a patient-inclusive approach to non-medical switching in conjunction with close clinical follow-up and disease monitoring.

The whole experience of public hospital physicians from several specialties with biopharmaceutical effectiveness, safety, adverse drug reactions and interchangeability: A qualitative study

BackgroundAlthough there is increasing support for biosimilar medicines by the Iraqi Ministry of Health (MOH), there is scarce information about whether physicians accept these medicines and support movement toward replacing reference medicines with their biosimilar counterparts. ObjectivesThe study objectives were to 1) explore in-depth the perceptions of Iraqi physicians working in public hospitals about the difference in effectiveness and safety between biosimilar medicines and their reference biological counterparts, 2) evaluate physicians' barriers to prescribing biosimilar medicines, 3) assess the adherence of physicians to the new pharmacovigilance regulations on reporting biopharmaceutical adverse drug reactions (ADRs) and 4) identify any barriers facing physicians to reporting biopharmaceutical- ADRs. MethodsThis qualitative study included face-to-face and virtual semi-structured interviews involving physicians from different disciplines who had experience with biological or biosimilar medicines. The interviews were conducted between November 6, 2020, and February 7, 2021. Thematic analyses were used to analyze qualitative data generated from the interviews. ResultsThe study sample included 36 physicians (6 women and 30 men) from seven different specialties at ten governmental hospitals mainly in Baghdad, and one physician was from Mosul, Iraq. Because most physicians had insufficient experience with biosimilar medications and were not sure about their effectiveness, the majority were hesitant to prescribe them. Most physicians preferred to prescribe reference biological medicines initially. However, the initial prescribing and switching between a reference and counterpart biosimilar relies on its availability. They chose biosimilar medications that have been approved by the U.S. FDA or EMA. Most physicians were unaware about the new pharmacovigilance regulations to report adverse biopharmaceutical reactions. The physicians tended to underreport biopharmaceutical ADRs and believed that inadequate physician-pharmacist collaboration negatively impacts preventing and reporting ADRs. ConclusionsMedicine procurement in healthcare settings should focus on sustainably securing high-quality biopharmaceuticals rather than looking only at costs to enhance physician experience and patient clinical outcomes. Promoting documentation, monitoring, and physician-pharmacist collaboration is pivotal to prevent, monitor, and treat biopharmaceutical ADRs.

Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan.

Aims Pharmacists in all clinical settings are recognized drug experts and integral educators of biosimilar medicines. Therefore, the objective of this study was to assess pharmacists' knowledge, predictors of knowledge, and views toward biosimilar medicines in Jordan. Methods A cross-sectional study was conducted in Jordan during October–December 2020. An Internet-based self-administrated questionnaire on knowledge and views was distributed using social media groups to the pharmacists among different areas in Jordan. A descriptive and univariate analysis was performed. Binary logistic regression was conducted to determine the predictors of knowledge including all variables with p < 0.20 on univariate analysis. Results A total 536 responses were received, 502 of which were completed (93.7% response rate). A total of 52.6% of the pharmacists were knowledgeable about biosimilar medicines and the mean of knowledge level was 6.47 ± 1.62 (range 2–10). Multivariate analysis identified that respondents who had heard about biosimilars before (OR = 1.942, 95% CI = 1.231–3.063, p < 0.05) was more likely to be knowledgeable. Respondents who had not taken the course or the postgraduating training course about biosimilars that were less likely to be knowledgeable (OR = 0.548, 95% CI = 0.357–0.839, p < 0.05). A positive response was noted in pharmacist's view regarding the implementation of biosimilar medicines in healthcare setting, biosimilar medicine prescription related to decreased costs, self-study about biosimilar medicine, and incorporating biosimilar education program at the pharmacy school curriculum universities level. Conclusions Pharmacists' views and knowledge vary regarding the particularities and key issues on biosimilar medicines in Jordan. Incorporating biosimilar course in pharmacy school curriculum could improve their acceptance for future pharmacy jobs.

Understanding the Experience of Hospital Pharmacists with the Effectiveness, Safety, Adverse Drug Reaction Reporting and Interchangeability of Biopharmaceutical Medicines

The study objectives were to 1) explore the real-world experience of hospital pharmacists with the differences in effectiveness safety, and interchangeability between biosimilar medicines and their reference biological counterparts, 2) reveal pharmacist recommendations to enhance the safety of biopharmaceutical medicines in public hospitals. The study has a mixed-method design where the core component was qualitative (interviews) and the supplemental component was quantitative (adverse drug reaction, ADR, reports). This qualitative component included semi-structured (mostly face-to-face) interviews involving hospital pharmacists from different hospitals with experience with biological or biosimilar medicines. The interviews were conducted from Nov 2020 through Feb 2021. Thematic analyses were used to analyze qualitative data generated from the interviews. The study sample included 25 pharmacists from ten governmental hospitals in Baghdad, Iraq. The pharmacists were 21 women and 4 men. Because most pharmacists had a short experience with biosimilar medications, they were unsure about their effectiveness and safety. Most pharmacists preferred reference biological over biosimilar medicines because of their effectiveness. However, they believed that initial prescribing and switching between a reference and counterpart biosimilar rely on their availability. The pharmacists tended to underreport biopharmaceutical ADRs. The non-sustainable supply of the same biopharmaceutical medicines in public hospitals negatively impacted pharmacist evaluation of the effectiveness and safety of biosimilar medicines. Both pharmacist interviews and the Iraqi Pharmacovigilance Center (IqPhvC) data showed under-reporting of biopharmaceutical ADRs. Medicine procurement in healthcare settings should focus on sustainably securing high-quality biopharmaceuticals rather than looking only at costs to enhance patient clinical outcomes. Providing pharmacist training, electronic reporting, promoting documentation, and following up with patients is pivotal to prevent, monitor and treat their ADRs.

Pharmaceutical regulation and policies in Austria

Austria is a middle-sized, high-income country in Central Europe with universal health coverage and a highly fragmented health care system. Medicines for outpatient use that are reimbursed by the social health insurance are price-regulated, whereas medicines for inpatient use are neither subject to price regulation nor to health technology assessment (HTA). These medicines are procured by hospitals, hospital groups and provinces which are the main owner of public hospitals. The major pricing policy for new medicines in the outpatient sector is external price referencing. Austria refers to all other 26 European Union (EU) Member States; the determined benchmark price must not exceed the EU average price. External price referencing is based on list prices, but the statutory manufacturer discounts applicable in some reference countries are considered. Regular price reviews with subsequent price adjustments are in place. For generic and biosimilar medicines to be included in the outpatient positive list, a price link policy is applied with different reduction rates for generics and biosimilars. In the supply chain, prices of all medicines are regulated through regressive mark-up schemes for wholesale and community pharmacies. The inclusion in the outpatient positive list is based on an HTA process which comprises pharmacological, medical-therapeutic and economic evaluations, followed by price negotiations about the reimbursement price. For medicines with high financial burden for the public payers, the Austrian Social Insurance (for the outpatient sector) and procurers for hospitals tend to conclude managed-entry agreements with confidential discounts. For outpatient medicines, patients are charged a fixed prescription fee per prescribed item; no further co-payments apply for outpatient or inpatient medicines. Studies have shown that the current pricing and reimbursement policies in Austria have contributed to keep prices of outpatient medicines stable (high-cost medicines tend to range above EU average), whereas the unregulated prices of medicines used in hospitals are frequently the highest in European comparison. Pharmacy mark-ups are also high in comparison to other European countries.