By Donald Zuhn --
Last month, the European Medicines Agency (EMEA) released a paper entitled "Questions and Answers on biosimilar medicines (similar biological medicinal products)," in which the EMEA provided answers to a number of questions concerning the authorization of biosimilars. The European biosimilar regulatory pathway was established in 2004. In view of recent attempts by Congress to enact biosimilar legislation (see "Senate Commitee Passes Biologics Legislation"), the EMEA paper is informative.
In the paper, the EMEA defines a "biological medicine" as a medicine whose active ingredient is made by or derived from a living organism (such as recombinant insulin produced by a bacterium carrying the insulin gene), a biological reference medicine" as an authorized biological medicine, and a "biosimilar medicine" as a medicine that is similar to the biological reference medicine. In describing the similarity between a biological reference medicine and a biosimilar medicine, the EMEA noted that, in general, both would be used "at the same dose to treat the same disease," but that because the two "are similar but not identical, the decision to treat a patient with a reference or a biosimilar medicine should be taken following the opinion of a qualified healthcare professional."
With regard to the authorization of biosimilars, the EMEA stated that such medicines could only be marketed after a suitable regulatory authority - such as the EMEA - had conducted a scientific evaluation of the efficacy, safety and quality of the medicine. The EMEA also noted that those seeking to market biosmilar medicines would be allowed to do so only after the expiration of "a period of data protection following the pharmaceutical legislation."
Since the active substance in the biological reference medicine and the biosmiliar medicine may differ slightly as a result of the methods of production, those seeking to market biosimilar medicines must perform studies specified by the European biosimilar legislation in order to ensure the similarity, safety, and efficacy of the biosimilar medicine. Such studies must establish that there are "no meaningful differences" between the safety and efficacy of the biological reference medicine and the biosimilar medicine. Submission of information regarding the corresponding biological reference medicine is not required.
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