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Kim Brown

Kim Brown is the AAPS communications and social media manager in the Public Outreach Department.

Biologic drugs (aka biologics), defined as a medicinal preparation made from living organisms and their products, are seen as one of the most promising new treatment options in the pharmaceutical pipeline. Numerous influences have recently led to the creation of European and U.S. approval procedures for biosimilar products, which are biologics that have been approved by regulatory agencies and have demonstrated comparability to the originator biologic. The efficacy of original biopharmaceutical products has resulted in sales totaling over $100 billion in 2010, and they are expected to reach $150 billion by 2016.

Improvements in the manufacturing, bioprocessing, and analytical testing methodologies indicate high potential for significant cost reduction in the development of biosimilars. As more blockbuster biologic drugs lose patent protection, the development of biosimilar versions is attracting increased market attention.

Biosimilar producers are now encouraging the Food and Drug Administration (FDA) to implement the new regulatory pathways mandated by the Affordable Care Act, a pathway largely endorsed based on the expectation of significant savings. FDA can encourage biologics sponsors to submit for approval of similar products that serve the same market, but it is ultimately up to the sponsors to submit applications. The implementation of this pathway will be the key factor to producing cost-effective, high-quality, safe, pure, and potent biosimilars that can enable a wider range of treatment choices for patients and their physicians.  While the European Medicines Agency has developed scientific guidance documents on biosimilars medicine, the FDA has recently issued three draft guidance documents on biosimilar product development.

What is the future landscape for biosimilar guidances?

This piece was reviewed by members of the AAPS Blog Committee.