The burgeoning field of biosimilars provides opportunities for biopharma and biotech companies to bring lower-cost products to the marketplace more rapidly than is possible for novel biologics. However, the time and cost saved by the decreased requirements for clinical testing results in the regulatory authorities placing very strong emphasis on the presentation of a firm foundation of structural analytical data to justify this, support the application and demonstrate that the candidate biologic is indeed worthy of being accepted as biosimilar. Richard L. Easton and Andrew J. Reason of BioPharmaSpec expand on what a biosimilar really is.

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