Version 1
: Received: 24 October 2022 / Approved: 26 October 2022 / Online: 26 October 2022 (03:58:16 CEST)
How to cite:
Niazi, S.K.; Al-Shaqha, W.M.; Mirza, Z. A Practical Guidance for Biosimilars Approval--Strategy for the ROW. Preprints2022, 2022100397. https://doi.org/10.20944/preprints202210.0397.v1
Niazi, S.K.; Al-Shaqha, W.M.; Mirza, Z. A Practical Guidance for Biosimilars Approval--Strategy for the ROW. Preprints 2022, 2022100397. https://doi.org/10.20944/preprints202210.0397.v1
Niazi, S.K.; Al-Shaqha, W.M.; Mirza, Z. A Practical Guidance for Biosimilars Approval--Strategy for the ROW. Preprints2022, 2022100397. https://doi.org/10.20944/preprints202210.0397.v1
APA Style
Niazi, S.K., Al-Shaqha, W.M., & Mirza, Z. (2022). A Practical Guidance for Biosimilars Approval--Strategy for the ROW. Preprints. https://doi.org/10.20944/preprints202210.0397.v1
Chicago/Turabian Style
Niazi, S.K., Waleed Mohammed Al-Shaqha and Zafar Mirza. 2022 "A Practical Guidance for Biosimilars Approval--Strategy for the ROW" Preprints. https://doi.org/10.20944/preprints202210.0397.v1
Abstract
Biological drugs are inaccessible to more than 80% of the world population due mainly to their high costs; this is a significant concern of the World Health Organization. Biosimilars are supposed to reduce the cost burden, but their approval process is complex, including expensive and irrelevant studies. While the Stringent Regulatory Authorities (SRAs) have adopted the guidance of the FDA or EMA, such adoptions are neither necessary nor practical for the rest of the world (ROW). We present a science-driven, rational approach to formulate regulatory guidelines that will enable faster biosimilars' entry into the ROW without compromising their safety and efficacy. The key recommendations include removing animal and safety efficacy testing, making analytical assessment more robust, and cGMP compliance assured through third-party audits. The ROW countries are also recommended to initiate a rapporteur system available in the EU, to overcome the biases and assure state-of-the-science evaluation as the common understanding of the critical quality attributes evolves. It is anticipated that stronger regional agencies like those in the MENA region, with the leadership of the Kingdom of Saudi Arabia, will help propel the idea faster across the globe.
Public Health and Healthcare, Health Policy and Services
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
