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A special issue of Pharmaceuticals (ISSN 1424-8247).

Deadline for manuscript submissions: closed (31 December 2020) | Viewed by 52443

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Special Issue Editors

Prof. Arnold G. Vulto

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Guest Editor

1. Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
2. Hospital Pharmacy, ErasmusMC, Rotterdam, The Netherlands
Interests: biosimilars; hospital pharmacy; clinical pharmacology; pharmacoeconomics

Prof. Steven Simoens

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Guest Editor

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium
Interests: economic evaluation; pharmaceutical policy; market access of innovative and off-patent medicines

Prof. Isabelle Huys

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Guest Editor

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium
Interests: IPR; legal and regulatory strategies for drug development

Special Issue Information

Dear Colleagues,

Biological medicinal products have contributed to the treatment of many diseases, e.g., autoimmune diseases and cancer, by targeting key disease mediators. These products represent a multibillion-dollar industry and continued growth in market share and expenditure is expected in the coming years. However, as patents and other exclusivity rights on many biological medicinal products are expiring or have expired, biosimilars can enter the market. The introduction of biosimilars may create competition, possibly resulting in reduced prices, altered market dynamics, revised competitive strategies of pharmaceutical companies; and might attract new players to the biopharmaceutical market. For healthcare systems, biosimilars may represent a tool to control healthcare expenses or expand patient access to treatment. Competition between off-patent biologicals and biosimilars may also induce incremental innovation and the development of next-generation biological medicinal products with, for example, a new formulation or route of administration.

This Pharmaceuticals Special Issue will focus on all facets of market access of off-patent biologicals, biosimilars, and next-generation biologicals in Europe, including policies and local practices that might influence market dynamics of these products. The editors welcome papers related to legal aspects, regulatory requirements, pricing, reimbursement and market uptake of off-patent biologicals, biosimilars and next-generation biologicals; and papers analyzing policy issues like tendering and reimbursement mechanisms, gainsharing practices, physician quotas, prescribing and switching frameworks, substitution, stakeholder perspectives, and education.

Scientific contributions to this Pharmaceuticals Special Issue can be review articles, as well as original qualitative or quantitative research articles.

We invite you to contact us if you would like to discuss suggestions for contributions or send us an abstract by 30 September 2020.

Prof. Arnold G. Vulto
Prof. Steven Simoens
Prof. Isabelle Huys
Guest Editors

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Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

biological medicinal products
biosimilars
off-patent biologicals
next-generation biologicals
Europe
market access
policies
local practices
legal aspects
regulatory requirements
pricing
reimbursement

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Published Papers (12 papers)

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Editorial

Jump to: Research, Review, Other

4 pages, 194 KiB

Open AccessEditorial

Emerging Insights into European Markets of Biologics, Including Biosimilars

by Steven Simoens and Isabelle Huys

Pharmaceuticals 2022, 15(5), 615; https://doi.org/10.3390/ph15050615 - 17 May 2022

Cited by 1 | Viewed by 1932

Abstract

Biological medicinal products have revolutionised the treatment of many diseases, e [...] Full article

(This article belongs to the Special Issue Biosimilars in Europe)

Research

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27 pages, 333 KiB

Open AccessArticle

Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices

by Liese Barbier, Steven Simoens, Caroline Soontjens, Barbara Claus, Arnold G. Vulto and Isabelle Huys

Pharmaceuticals 2021, 14(6), 499; https://doi.org/10.3390/ph14060499 - 24 May 2021

Cited by 23 | Viewed by 6026

Abstract

Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully elucidated how tenders for off-patent biologicals and biosimilars are designed and if approaches are aligned with sustaining market competition and societal savings for healthcare systems over the long term. This study aims to (i) explore the design and implementation of tender procedures for off-patent biologicals and biosimilars in Europe, (ii) identify learnings for sustainable tender approaches from purchasers and suppliers, and (iii) formulate recommendations in support of competitive and sustainable tender practices in the off-patent biologicals market. Methods: A mixed methods design was applied. A quantitative web-survey was conducted with hospital pharmacists and purchasers (N = 60, of which 47 completed the survey in full), and qualitative expert-interviews with purchasers and suppliers (N = 28) were carried out. Results: The web survey results showed that the organization and design of tenders for off-patent biologicals and biosimilars, and the experience of hospital pharmacists and purchasers with this, considerably varies on several elements across European countries. From the qualitative interviews, signals emerged across the board that some of the current tender approaches might negatively affect market dynamics for off-patent biologicals and biosimilars. The focus on generating short-term savings and existence of originator favouring tender practices were identified as elements that may limit timely competition from and market opportunity for biosimilar suppliers. The need to optimize tender processes, considering a more long-term strategic and sustainable view, was expressed. In addition, challenges appear to exist with differentiating between products beyond price, showing the need and opportunity to guide stakeholders with the (appropriate) inclusion of award criteria beyond price. Due to the variety in tender organization in Europe, a ‘one size fits all’ tendering framework is not possible. However, on an overarching level, it was argued that tender procedures must aim to (i) ensure market plurality and (ii) include award criteria beyond price (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions may be needed. Conclusions: Findings suggest the need to adjust tender procedures for off-patent biologicals and biosimilars, considering a more long-term strategic and market sustainable view. Five main avenues for optimization were identified: (i) safeguarding a transparent, equal opportunity setting for all suppliers with an appropriate use of award criteria; (ii) fostering a timely opening of tender procedures, ensuring on-set competition; (iii) ensuring and stimulating adherence to laws on public procurement; (iv) securing an efficient process, improving plannability and ensuring timely product supply and (v) safeguarding long-term sustainable competition by stimulating market plurality. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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7 pages, 511 KiB

Open AccessArticle

Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study

by Steven Simoens, Arnold G. Vulto and Pieter Dylst

Pharmaceuticals 2021, 14(5), 450; https://doi.org/10.3390/ph14050450 - 11 May 2021

Cited by 7 | Viewed by 4031

Abstract

This study aimed to compare drug costs and healthcare costs of a 1 year adjuvant course with intravenous biosimilar trastuzumab vs. subcutaneous reference trastuzumab in HER2-positive breast cancer from the Belgian hospital perspective. Our simulation is based on the methodology used by Tjalma and colleagues, and considered costs of drugs, healthcare professional time and consumables. We calculated intravenous drug costs for different body weights, and computed drug costs and healthcare costs to treat 100 patients with either trastuzumab formulation, assuming a binomial body weight distribution in this sample. Scenarios were run to account for drug discounts and intravenous vial sharing. Drug costs amounted to €1,431,282 with intravenous biosimilar trastuzumab and €1,522,809 with subcutaneous reference trastuzumab for a sample of 100 patients in the base case analysis. When healthcare professional time and consumables were also considered, healthcare costs with intravenous biosimilar trastuzumab were similar to those with subcutaneous reference trastuzumab. Differences in healthcare costs between intravenous biosimilar trastuzumab and subcutaneous reference trastuzumab depended on the level of discounts on these formulations and on intravenous vial sharing. Our case study demonstrates that comparing costs of intravenous vs. subcutaneous formulations is complex and multifactorial, and entails more than a simple cost comparison of products. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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16 pages, 2001 KiB

Open AccessArticle

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

by Manuel García-Goñi, Isabel Río-Álvarez, David Carcedo and Alba Villacampa

Pharmaceuticals 2021, 14(4), 348; https://doi.org/10.3390/ph14040348 - 9 Apr 2021

Cited by 9 | Viewed by 5282

Abstract

Since the first biosimilar medicine, Omnitrope^® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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15 pages, 2307 KiB

Open AccessArticle

Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities

by Beverly Ingram, Rebecca S. Lumsden, Adriana Radosavljevic and Christine Kobryn

Pharmaceuticals 2021, 14(4), 306; https://doi.org/10.3390/ph14040306 - 1 Apr 2021

Cited by 2 | Viewed by 5183

Abstract

Slow uptake of biosimilars in some regions is often attributed to a lack of knowledge combined with concerns about safety and efficacy. To alleviate physician and patient apprehensions, regulatory reviews from four major regulatory authorities (RAs) (European Medicines Agency, US Food and Drug Administration, Health Canada, and Japan Pharmaceuticals and Medical Devices Authority) across a portfolio of eight biosimilars were analyzed to provide insight into RA review focus and approach. RA queries were evaluated in an unbiased and systematic manner by major classification (Chemistry, Manufacturing and Controls [CMC], nonclinical, clinical or regulatory) and then via detailed sub-classification. There was a consistent, predominant focus on CMC from all RAs. The review focus based on sub-classification of clinical and regulatory queries was influenced by molecular complexity, with significant differences between categories (monoclonal antibody or protein) in the distribution of query topics; specifically, bioanalytical (p = 0.023), comparative safety and efficacy (p = 0.023), and statutory (including the justification of extrapolation) (p = 0.00033). Each biosimilar had a distinct distribution of clinical query topics, tailored to product-specific data. This analysis elucidated areas of heightened RA interest, and validated their application of regulatory science in the evaluation of biosimilar safety and efficacy. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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15 pages, 838 KiB

Open AccessArticle

Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars

by Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens and Helga Gardarsdottir

Pharmaceuticals 2021, 14(3), 189; https://doi.org/10.3390/ph14030189 - 25 Feb 2021

Cited by 5 | Viewed by 3364

Abstract

Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists concerning how EU regulators reflect the biosimilarity assessments of (pC)QAs in European public assessment reports (EPARs) by different stakeholders. The type and extent of information on QAs and pCQAs in EPARs were evaluated for seven adalimumab biosimilars. Seventy-seven QAs, including 31 pCQAs, were classified and assessed for type (structural and functional attributes) and extent (biosimilarity interpretation and/or test results) of information in EPARs. Reporting on the QAs (35–75%) varied between EPARs, where the most emphasis was placed on pCQAs (65–87%). Functional attributes (54% QAs and 92% pCQAs) were reported more frequently than structural attributes (8% QAs and 22% pCQAs). About 50% (4 structural and 12 functional attributes) of pCQAs were consistently reported in all EPARs. Regulators often provided biosimilarity interpretation (QAs: 83% structural and 80% functional; pCQAs: 81% structural and 78% functional) but rarely include test results (QAs: 1% structural and 9% functional and pCQAs: 3% structural and 9% functional). Minor differences in structural attributes, commonly in glycoforms and charge variants, were often observed in adalimumab biosimilars but did not affect the functions and clinical profile. Despite the variability in reporting QAs in EPARs, the minor observed differences were largely quantitative and not essentially meaningful for the overall conclusion of biosimilarity of the seven adalimumab biosimilars. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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10 pages, 891 KiB

Open AccessFeature PaperArticle

Did the Introduction of Biosimilars Influence Their Prices and Utilization? The Case of Biologic Disease Modifying Antirheumatic Drugs (bDMARD) in Bulgaria

by Konstantin Tachkov, Zornitsa Mitkova, Vladimira Boyadzieva and Guenka Petrova

Pharmaceuticals 2021, 14(1), 64; https://doi.org/10.3390/ph14010064 - 14 Jan 2021

Cited by 5 | Viewed by 2886

Abstract

The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a combined qualitative and quantitative analysis of time of entry of biosimilars on the national market and the respective changes in the prices and utilization during 2015–2020. We found 58 biosimilars for 16 reference products authorized for sale on the European market by the end of 2019, but for 2 of the reference products biosimilars were not found on the national market. Only inflammatory joint disease had more than one biosimilar molecule indicated for therapy. Prices of the observed bDMARD decreased by 17% down to 48%. We noted significant price decreases upon biosimilar entrance onto the market. In total, the reimbursed expenditures for the whole therapeutic group steadily increased from 72 to 99 million BGN. Utilization changed from to 0.5868 to 2.7215 defined daily dose (DDD)/1000inh/day. Our study shows that the entrance of biosimilars in the country is relatively slow because only half of the biosimilars authorized in Europe are reimbursed nationally. Introduction of biosimilars decreases the prices and changes the utilization significantly but other factors might also contribute to this. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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20 pages, 1609 KiB

Open AccessArticle

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

by Evelien Moorkens, Teresa Barcina Lacosta, Arnold G. Vulto, Martin Schulz, Gabriele Gradl, Salka Enners, Gisbert Selke, Isabelle Huys and Steven Simoens

Pharmaceuticals 2020, 13(10), 324; https://doi.org/10.3390/ph13100324 - 21 Oct 2020

Cited by 23 | Viewed by 5508

Abstract

Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010–2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers’ and insurers’ views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variations across the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions). Quantitative analyses indicated that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions. Through qualitative interview analyses, this study showed that the use of infliximab and etanercept biosimilars across Germany is primarily influenced by (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms to ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts, and (3) gainsharing arrangements established at the insurer-prescriber level. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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Review

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15 pages, 361 KiB

Open AccessReview

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

by Félix Lobo and Isabel Río-Álvarez

Pharmaceuticals 2021, 14(3), 283; https://doi.org/10.3390/ph14030283 - 22 Mar 2021

Cited by 13 | Viewed by 3991

Abstract

Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between health systems and professionals. Likewise, incentives are an important element of clinical governance understood as health services’ management at the micro-level, aimed at achieving better health outcomes for patients. In Spain, monetary and non-monetary incentives are sometimes used in the health services, but not as frequently as in other countries. There are already several examples in European countries of initiatives searching the promotion of biosimilars through different sorts of incentives, but not in Spain. Hence, this paper is aimed at identifying the barriers that incentives to prescribe biosimilars might encounter in Spain, with particular interest in incentives in the framework of clinical governance. Both questions are intertwined. Barriers are presented from two perspectives. Firstly, based on the nature of the barrier: (i) the payment system for health professionals, (ii) budget rigidity and excessive bureaucracy, (iii) little autonomy in the management of human resources (iv) lack of clinical integration, (v) absence of a legal framework for clinical governance, and (vi) other governance-related barriers. The second perspective is based on the stakeholders involved: (i) gaps in knowledge among physicians, (ii) misinformation and distrust among patients, (iii) trade unions opposition to productivity-related payments, (iv) lack of a clear position by professional associations, and (v) misalignment of the goals pursued by some healthcare professionals and the goals of the public system. Finally, the authors advance several recommendations to overcome these barriers at the national level. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

21 pages, 719 KiB

Open AccessEditor’s ChoiceReview

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations

by Yannick Vandenplas, Steven Simoens, Philippe Van Wilder, Arnold G. Vulto and Isabelle Huys

Pharmaceuticals 2021, 14(2), 117; https://doi.org/10.3390/ph14020117 - 4 Feb 2021

Cited by 33 | Viewed by 5612

Abstract

Biosimilar medicines support the sustainability of national healthcare systems, by reducing costs of biological therapies through increased competition. However, their adoption into clinical practice largely depends on the acceptance of healthcare providers and patients. Patients are different from health care professionals (HCPs), who are informing themselves professionally. For patients, the biosimilar debate only becomes actual when they are confronted with disease and drug choices. This paper provides a literature review on how patients are and should be informed about biosimilars, searching in scientific databases (i.e., Medline, Embase). Several large surveys have shown a lack of knowledge and trust in biosimilars among European patients in recent years. This review identified five main strategies to inform patients about biosimilars: (1) provide understandable information, (2) in a positive and transparent way, (3) tailored to the individual’s needs, (4) with one voice, and (5) supported by audiovisual material. Moreover, the importance of a multistakeholder approach was underlined by describing the role of each stakeholder. Patients are a large and diffuse target group to be reached by educational programs. Therefore, patient associations have become increasingly important in correctly informing patients about biosimilar medicines. This has led to widespread biosimilar information for patients among European patient associations. Therefore, a web-based screening of European Patients’ Forum (EPF) and International Alliance of Patients’ Organizations (IAPO) member organizations on publicly available information about biosimilars was performed. We found that the level of detail, correctness, and the tone of the provided information varied. In conclusion, it is paramount to set up a close collaboration between all stakeholders to communicate, develop, and disseminate factual information about biosimilars for patients. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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17 pages, 8201 KiB

Open AccessReview

Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

by Arnold G. Vulto, Jackie Vanderpuye-Orgle, Martin van der Graaff, Steven R. A. Simoens, Lorenzo Dagna, Richard Macaulay, Beenish Majeed, Jeffrey Lemay, Jane Hippenmeyer and Sebastian Gonzalez-McQuire

Pharmaceuticals 2020, 13(11), 400; https://doi.org/10.3390/ph13110400 - 17 Nov 2020

Cited by 10 | Viewed by 4242

Abstract

Introduction: Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe. Methods: The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion. Results: Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability. Conclusions: A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation. Full article

(This article belongs to the Special Issue Biosimilars in Europe)

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Other

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6 pages, 231 KiB

Open AccessCommentary

The Off-Patent Biological Market in Belgium: Is the Health System Creating a Hurdle to Fair Market Competition?

by Philippe Van Wilder

Pharmaceuticals 2021, 14(4), 352; https://doi.org/10.3390/ph14040352 - 10 Apr 2021

Cited by 5 | Viewed by 2378

Abstract

We investigated the off-patent biological market in Belgium from a policy maker’s perspective, in light of the Belgian pharmaceutical health system. The main barriers relate to a short-term budgetary focus, to the overwhelming innovator’s reach and to a concertation model with assessment and [...] Read more.

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