Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters

Author:

Mielke Johanna1ORCID,Woehling Heike2,Jones Byron1

Affiliation:

1. Novartis Pharma AG; Basel Switzerland

2. Sandoz Biopharmaceuticals; Holzkirchen Germany

Funder

Marie Sklodowska-Curie

Swiss State Secretariat for Education, Research, and Innovation (SERI)

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference34 articles.

1. On the regulatory approval pathway of biosimilar products;Wang;Pharmaceuticals,2012

2. Statistical and regulatory considerations in assessments of interchangeability of biological drug products;Tóthfalusi;Eur J Health Econ,2014

3. Questions and answers on biosimilar medicines (similar biological medicinal products) 2012 http://www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf

4. Interchangeability of biosimilars-position of Finnish Medicines Agency Fimea 2015 https://www.fimea.fi/documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf

5. Guide to biosimilars for healthcare professionals and patients https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-biosimilars-for-healthcare-professionals-and-patients-v2.pdf?sfvrsn=18 2015

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3. Biosimilar Drug Development;Principles and Practice of Clinical Trials;2020

4. Biosimilars for the treatment of psoriasis;Expert Opinion on Biological Therapy;2019-07-01

5. Les biosimilaires en Médecine Interne : bien les connaître pour bien les prescrire;La Revue de Médecine Interne;2019-01

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