Abstract: The Biologics Price Competition and Innovation Act (BPCIA) was enacted by Congress in 2010 as part of the Affordable Care Act. The BPCIA was intended to help innovators and pharmaceutical drug developers by streamlining the regulation of biologics, much as the Hatch-Waxman Act of 1984 did with respect to small molecule generic drugs. Unlike the Hatch-Waxman Act however, which only covered small molecule generic drugs, the BPCIA regulates large molecule drugs with “no clinically meaningful difference” to the reference product. Biologics, under the BPCIA, are complex molecules such as viruses or therapeutic serums produced for the purpose of preventing, treating, or curing human diseases or conditions. In enacting the BPCIA, Congress sought to facilitate the development and marketing of biosimilars and increase competition amongst drug developers as well as provide a specific process for potential patent infringement claims. Biosimilars are biologics that are “highly similar” to a reference product with no clinically meaningful difference between the biosimilar and the reference product in terms of “safety, purity, and potency of the product.” Recognizing biosimilars as a separate class of products allows drug development companies to produce a drug that is clinically equivalent to a drug already patented and on the market, thus spurring innovation and competition between drug developers and pharmaceutical companies. Because the biosimilar has a reference drug, under the BPCIA, the developer of the biosimilar is able to use clinical data already collected for the reference drug and apply that data for approval from the FDA for their biosimilar. Since the biosimilar developer, referred to as a subsection (k) applicant in 42 USC § 262, does not have to compile its own clinical data regarding the safety, purity, and potency of its drug, the path towards FDA approval is consequently faster, more certain, and less expensive. However, as a result of this streamlined process, the BPCIA also raises issues involving patent infringement and patent litigation, as several cases have been filed primarily concerning the interpretation of the BPCIA and its specific biosimilar approval process requirements.
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