In light of the expected end of patent terms for many large molecule drugs called biologics, there has been a rise in the development of biosimilars—non-branded, copycat versions of biologics. Unlike generic drugs, which are non-branded versions of small molecule chemical drugs, biosimilars are not identical to the biologic they reference, since biologics are derived from living organisms and are often injected into the patient, which makes them impossible to replicate perfectly. Despite their complexities, biologics exist to treat important diseases such as AIDS, Alzheimer’s, and cancer. In 2010, the Biologics Price Competition and Innovation Act (Biosimilars Act) was added to the Public Health Service Act (PHS Act), outlining the approval process and regulatory plan for biosimilars. The Food and Drug Administration (FDA) subsequently released six Draft Guidance Documents (Guidance Documents) to clarify some of the provisions in the Biosimilars Act and to define ambiguous terms and phrases. Although biosimilars have been an important treatment option in many countries for over twenty years, none have been approved in the United States. On March 15, 2015, the FDA approved Sandoz’s Zarxio after the FDA’s Oncological Drugs Advisory Committee recommended approval by the agency. However, on May 5, 2015, the Appeals Court for the Federal Circuit granted an injunction preventing Sandoz from selling Zarxio until further arguments are heard. The FDA may be progressing toward a more lenient view on biosimilar approvals; however, the court’s injunction indicates that the United States lags in its exploitation of biosimilars, and revisions to the current law will allow for a robust biosimilars market. Previous scholarship has outlined the barriers to biosimilar acceptance in the United States and acknowledged the potential benefit of higher approval rates. This Note analyzes the Biosimilars Act and the Guidance Documents, and proposes revisions to these documents and to the current structure of the insurance and health care systems in relation to biosimilars. These adaptations will allow the United States to improve access to key medical treatments across the country and catch up with other biosimilar markets.
Biosimilar Regulation: Bringing the United States Up To Speed with Other Markets.
Minnesota Journal of Law, Science & Technology.
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