Christopher Webster | Principal

Christopher Webster, Principal, BioApprovals

Chris Webster is a regulatory affairs consultant specialising in biologics and vaccines and principal of BioApprovals. Before founding BioApprovals, Chris led regulatory affairs groups at different companies for over 25 years, most recently heading biosimilars at Baxalta and previously leading development or policy programmes at Vertex, Novartis, Millennium and Pfizer. Chris’s involvement with biosimilars began in the late 1990s, when he represented Pfizer on the biotechnology committee of PhRMA and was the lead author of one of the group’s position papers on biosimilars. Chris believes that biosimilars can greatly enhance the access of patients to needed treatments and that patients benefit when product sponsors do not face unnecessary data burdens for the approval of their products. For the last few years, Chris’s published work has focused on simplifying the data burden upon biosimilar sponsors by the careful application of scientific realities and regulatory precedents. Chris graduated in veterinary medicine at the University of Edinburgh and holds a doctorate in immunology from the University of London.


Festival of Biologics Day 2 @ 12:30

Evidentiary Consistency and Regulatory Efficiency in Development of Biosimilars

  • The endpoint of comparability is the critical indistinguishability of the clinical properties of the compared products.
  • To be efficient, regulators should apply consistent evidentiary requirements and logic to both biosimilars and manufacturing changes of all biologics.
  • Approval of biosimilars through regulatory reliance is a logical outcome that would enhance regulatory efficiency and access for patients.
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT

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