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Abstract

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval and patent protection. These hurdles are somewhat in tension with each other. The more similar biosimilars are to their pioneer counterparts, the more easily they may advance to market via the Biologics Price Competition and Innovation Act's ("BPCIA") new accelerated approval pathway. While the FDA has provided some guidance about how much similarity is likely to suffice, the standard is not yet clearly defined. In contrast, the more similar two drugs are to one another, the less likely that they will be able to obtain patent protection. Further, biologic drugs pose special issues when considering various legal factors required for patentability. Resolving these questions for the optimal benefit of all stakeholders requires both fundamental institutional competency and a willingness on the part of decision makers to engage with difficult scientific questions. This Note explores these ongoing challenges, with particular focus on the clinical and litigation history of the TNFá inhibitors Humira, Enbrel, and Remicade.

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