Exploration of Musculoskeletal Diseases

From: Biologics and biosimilars in musculoskeletal diseases: addressing regulatory inconsistencies and clinical uncertainty

Table 4. Biosimilar substitution policies across EU countries [17]

Country	Automatic substitution allowed?	Policy details
Czechia	Yes	Automatic substitution at pharmacy level
Estonia	Yes	Automatic substitution at pharmacy level
France	Conditional	Allowed for treatment-naive or same-group patients unless prohibited by physician
Latvia	Yes	Automatic substitution at pharmacy level
Poland	Yes	Automatic substitution at pharmacy level
Denmark	No	Physician-driven substitution encouraged
Germany	No	Physician-driven substitution encouraged
Netherlands	No	Physician-driven substitution encouraged
Italy	No	Physician-driven substitution encouraged
Spain	No	Physician must explicitly prescribe biosimilar
Sweden	No	Physician-driven substitution encouraged

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EU: European Union

Declarations

Author contributions

LNM and DM: Writing—original draft, Writing—review & editing. SRF: Conceptualization, Supervision, Writing—review & editing. All authors read and approved the submitted version.

Conflicts of interest

Steven R. Feldman has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Leo Pharma, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate, and National Psoriasis Foundation. He is the founder and majority owner of http://www.drscore.com/ and founder and part-owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment. The other authors have no conflicts to disclose.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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