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 Workshop on Biopharmaceutical and EMEA Biosimliar Guidelines |
| Introduction |
Workshop on Biopharmaceutical and EMEA Biosimliar Guidelines The biotechnology revolution has given patients new hopes to fight disease, including cancer and viral infections. Other products of biotechnology, such as vaccines, genes, and oligonucleotides, are holding the key to the success of preventive health care. Being orders of magnitude more complex than conventional small molecules, new rules in formulation and dosing are often required. Despite many structure-function and ¡V toxicity studies, it is still not possible to predict the impact of however minor changes in structure of a biopharmaceutical on efficacy or toxicity ¡V changes that may be introduced during manufacture or clinical use. Such uncertainties pose considerable challenge to regulatory scientists in rendering a decision on product approval. The term ¡§biosimilars¡¨ is adopted as the nomenclature for the ¡§generic¡¨ version of the innovator biopharmaceutical product. Unlike conventional drug molecules, the chemical identity of the active pharmaceutical ingredient may not necessarily be the same. Adding to the complexity is that the formulation composition may also not necessarily be the same. This situation raises the question, "Under what condition would a biosimilar product be considered as safe and effective as the innovator biopharmaceutical product?"
This workshop was organized to highlight the important issues unique to the delivery of biopharmaceuticals. It is a forum to examine the role of manufacturing complexities and possible immunogenicity of biopharmaceuticals in determining the stringency of a risk management plan. Towards that end, a case study of erythropoietin will be considered. The key aspects and the thinking behind the European guidelines will be evaluated, and contrasted with the guidelines in different Asian Pacific countries. The workshop will conclude with a panel discussion on the aspects of biosimilars that should be clarified as Hong Kong is gearing up to formulate its own set of guidelines.
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