COCERIG ISSUES WITH BIOSIMILARS: AOVERVIEW

Summary Biopharmaceuticals are biological medicinal products that have been developed through biotechnological practices, including recombinant human technology, gene technology or antibody methods. The imminent patent expiration of many biopharmaceutical products will produce the possibility for generic versions of these therapeutic agents (i.e.biosimilars). Biosimilars differ from generic low molecular weight chemical drugs in many important ways. These include the size and complexity of the active substance, which will affect the scientific requirement for testing; the nature of the starting materials (cell banks, tissues, and other biological products); the complexity of the manufacturing processes; and the limitations of state-ofthe-art methods to characterize proteins and to detect all product variations that can influence clinical efficacy, sideeffects like immunogenicity. Therefore, it was acknowledged that established legal and regulatory principles of ‘essential similarity’ that are applied to standard generics cannot be readily applied to biosimilars. Thus, verification of the similarity to or substitutability of biosimilars with reference innovator biopharmaceutical products will require much more than a demonstration of pharmacokinetic similarity, which is sufficient for