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With many blockbuster biological drugs now, or soon to be off patent, there has been great interest in developing follow-on versions, termed biosimilars. Biosimilars have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. Unlike generic small molecule drugs creating an exact copy of a therapeutic protein is impossible. As a result regulatory agencies evaluate this category of biologics based on their level of similarity to, rather than the exact replication of the innovator drug.
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