Evaluation of similar biotherapeutic products: Scientific and regulatory challenges

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...

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...