Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices Article Swipe
Liese Barbier
,
Steven Simoens
,
Caroline Soontjens
,
Barbara Claus
,
Arnold G. Vulto
,
Isabelle Huys
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.3390/ph14060499
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.3390/ph14060499
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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/ph14060499
- https://www.mdpi.com/1424-8247/14/6/499/pdf
- OA Status
- gold
- Cited By
- 31
- References
- 20
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3165244044
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3165244044Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.3390/ph14060499Digital Object Identifier
- Title
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Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable PracticesWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-05-24Full publication date if available
- Authors
-
Liese Barbier, Steven Simoens, Caroline Soontjens, Barbara Claus, Arnold G. Vulto, Isabelle HuysList of authors in order
- Landing page
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https://doi.org/10.3390/ph14060499Publisher landing page
- PDF URL
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https://www.mdpi.com/1424-8247/14/6/499/pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://www.mdpi.com/1424-8247/14/6/499/pdfDirect OA link when available
- Concepts
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Biosimilar, Call for bids, Procurement, Competition (biology), Business, Market share, Marketing, Medicine, Ecology, Internal medicine, BiologyTop concepts (fields/topics) attached by OpenAlex
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31Total citation count in OpenAlex
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2025: 5, 2024: 11, 2023: 6, 2022: 8, 2021: 1Per-year citation counts (last 5 years)
- References (count)
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20Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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