Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation

Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)

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Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)

Biosimilar Products Scientific Principles , Challenges , and Opportunities

T he Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and regulatory aspects in the development of biosimilar products. Such products are becoming an increasingly important area of interest for both the biopharmaceutical industry and regulatory agencies. Biosimilars are highly complex, and scientists have be...

Response regarding Colombian regulation of biotherapeutic products.

Regarding a letter by Erika Lietzan (1) addressing our article on regulating biotechnology drugs in Colombia (2), we offer the following response. As Lietzan states, it is true that there is a global consensus on the two regulatory pathways to obtaining market authorization for biological medicines: the full dossier pathway for pioneer products and an abbreviated pathway for competitors (biosim...

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia....