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Rahalkar H, Cetintas HC, Salek S. Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. Front Pharmacol. 2018;9:1079doi: 10.3389/fphar.2018.01079.
Rahalkar, H., Cetintas, H. C., & Salek, S. (2018). Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. Frontiers in pharmacology, 91079. https://doi.org/10.3389/fphar.2018.01079
Rahalkar, Hasumati, et al. "Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines." Frontiers in pharmacology vol. 9 (2018): 1079. doi: https://doi.org/10.3389/fphar.2018.01079
Rahalkar H, Cetintas HC, Salek S. Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. Front Pharmacol. 2018 Sep 28;9:1079. doi: 10.3389/fphar.2018.01079. eCollection 2018. PMID: 30364154; PMCID: PMC6192287.
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Front Pharmacol. 2018 Sep 28;9:1079. doi: 10.3389/fphar.2018.01079. eCollection 2018.

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines.

Frontiers in pharmacology

Hasumati Rahalkar, Hacer Coskun Cetintas, Sam Salek

Affiliations

  1. School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
  2. Department of Regulatory Sciences, Metina PharmConsulting Pvt Ltd, Mumbai, India.
  3. Department of Marketing Authorization of Medicines, Turkish Medicines and Medical Devices Agency, Ankara, Turkey.

PMID: 30364154 PMCID: PMC6192287 DOI: 10.3389/fphar.2018.01079

[No abstract available.]

Keywords: biosimilar; comparability; emerging markets; manufacturing; monoclonal antibody; non-clinical; quality; regulatory

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