[1] WHO. Guidelines on Evaluation of Similar Biotherapeutic Products. 2009.
[2] EMA/CHMP/BMWP/572643/2011. Concept paper on the revision of the guideline on similar biological medicinal product. 2011.
[3] Biologics Price Competition and Innovation Act of 2009 (BPCIA) - Patient Protection and Affordable Care Act. Public Law No: 111-148. Title VII, Subtitle A, 7001 to 7003.
[4] Chirino A. et al. Characterizing biological products and assessing comparability following manufacturing changes. Nat. Biotechnol. 2004; 22: 1383-1391.
[5] Eudralex Volume 4 - Annexe 2. Manufacture of Biological Medicinal Substances and Products for Human Use. Draft 2010.
[6] EMA/CHMP/BMWP/403543/2010. Guideline on similar biological medicinal products containing monoclonal antibodies. 2010.
[7] EMA/CHMP/BWP/617111/2010. Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues - 2011.
[8] EMA/CHMP/BMWP/572828/2011. Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues. 2011.
[9] Kozlowski S. et al. Developing the Nation’s Biosimilars Program. N. Engl. J. Med. 2011; 365(5): 385-388.
[10] Rathore A. et al. Quality by design for biopharmaceuticals. Nat. Biotechnol. 2009; 27: 26-34.
[11] Schiestl M. et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals., Nat. Biotechnol. 2011; 29: 310-312.
[12] ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process - 2004.
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