Streamlining biosimilar development based on 20 years’ experience

Author:

Nick Cecil1

Affiliation:

1. Parexel International, Uxbridge

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Reference63 articles.

1. EMA: Medicines | European Medicines Agency (europa.eu). [Internet]. Amsterdam. Available at: https://www.ema.europa.eu/medicines: searched “medicine” + “monoclonal“between 2013 November 14 and 2023 November 14 excluded “biosimilars” + “withdrawn products” [cited 2023 November 15]

2. ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised guideline. Organisation of the common technical document for the registration of pharmaceuticals for human use (M4). Current Step 4 version. [Internet} 2016June 15 2016. Available at: https://database.ich.org/sites/default/files/M4._R4__Guideline.pdf [cited 2023 November 15]

3. CHMP: Committee for Medicinal products for Human (CHMP) guideline on non-clinical and clinical development of similar biological medicinal products containing low molecular-weight-heparins [Internet]. 2016 November 10. EMA/CHMP/BWP/118264/2007 Rev. 1. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-development-similar-biological-medicinal-products-containing-low_en.pdf [cited 2023 November 15]

4. FDA: “Deemed to be a License” Provision of the BPCI Act. 2020 April 4. Available at:. Available at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act#:~:text=The%20Biologics%20Price%20Competition%20and biologics%20license%20application%20(BLA)%20under . [cited 2023 November 15]

5. Kang HN. WHO activities related to regulatory standardization of biosimilars. Norms and standards for biological products. Presented at IPRP Biosimilars Working Group Workshop: “increasing the efficiency of biosimilar development programs-re-evaluating the need for comparative clinical efficacy studies (CES)” IPRP Biosimilars Working Group (BWG) Session 1: Setting the stage—How have we been using comparative clinical efficacy studies (CES) in biosimilar development programs and what have we learned? 2023 September 12. [Internet]. Available at: https://www.fda.gov/media/172197/download. [cited 2023 November 15]

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