A Practice Note discussing the drug approval process for biosimilars under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This Note discusses the BPCIA's abbreviated biologics license application (aBLA) pathway for biosimilar and interchangeable biological drug products, data protection and market exclusivity provisions, and patent dispute resolution procedures. It also discusses the Food and Drug Administration's (FDA's) guidance documents and state regulations concerning biological products.