The Biologics Price Competition and Innovation Act of 2009 (BPCIA), embedded in the Patient Protection and Affordable Care Act (PPACA), established a statutory approval pathway and patent dispute resolution scheme for biological medicines. The biotechnology and pharmaceutical industries must be ready to implement BPCIA strategies once the FDA’s regulatory framework is finalized. This article will provide an overview of biologics, the scientific issues surrounding implementation of an abbreviated biosimilar licensure pathway, the biosimilar regulatory process and the BPCIA’s new patent information exchange and litigation provisions.
Biologics
Biologics are complex medicinal agents produced and then isolated from living bioreactors, such as micro-organisms, animal cells or animals. Examples of biologics include blood components, nucleic acids for gene therapies, proteins, tissues, cells and vaccines. Specific examples on the market include Humira (rheumatoid arthritis), Avastin (cancer) and Epogen (anemia). Biologics are large “macromolecules” that are more complex than small-molecule drugs, which have an easily defined structure. The complexity of biologics makes it difficult for a generic manufacturer to produce an identical version of an innovator’s biologic. Instead, a generic manufacturer may only be able to produce a similar agent, a biosimilar.
