Randomized controlled trials do not always fit the purpose: A science-based response to Venetis and Mol’s editorial on biosimilars of follitropin alfa

Author:

de Mora Fernando,Howles Colin M.

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference10 articles.

1. Biosimilars versus the originator of follitropin alfa: Randomized controlled trials are still the best way to evaluate their comparative effectiveness in assisted reproduction;Venetis;Drug Discov. Today,2022

2. Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get?;de Mora;Drug Discov. Today,2022

3. European Medicines Agency (EMA) (2012) Questions and answers on biosimilar medicines (similar biological medicinal products) EMA/837805/2011. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf [Published September 27, 2012. Accessed January 31, 2023].

4. Evolution of the EU biosimilar framework: past and future;Wolff-Holz;BioDrugs,2019

5. Regulatory evaluation of biosimilars: Refinement of principles based on the scientific evidence and clinical experience;Kurki;BioDrugs,2022

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