Drug Discovery Today (01/06/2015) Li, E.C.; Abbas, R.; Jacobs, I.A.

Globally, interest in the development of biosimilar products has increased as a result of the widespread use and patent expiration of many biologics, report researchers from University of New England College of Pharmacy and Pfizer. However, biosimilar development is much more rigorous than the development of a generic small molecule drug, and a number of regulatory agencies have set or are planning to establish guidelines to ensure that the safety and efficacy of a biosimilar are highly similar to its reference product. The researchers note the importance of the early clinical phase of biosimilar development. This phase is key to resolving any remaining uncertainties following in vitro and in vivo evaluations as well as for enabling a selective and targeted approach to Phase III clinical efficacy and safety studies.

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