Biopharming / Biopharming regulations
How are plant-made pharmaceuticals regulated?
Novel plant-made pharmaceuticals (PMPs) follow the same regulatory approval processes as other biologic (large molecule) protein drugs. Government agencies responsible for regulating the safety, efficacy and quality of biologic drug products include:
The first PMP approved for human use was Elelyso (taliglucerase alfa), an enzyme produced in carrot cells by Israel-based Protalix Biotherapeutics Inc. (commercial rights sold to Pfizer in 2015). The FDA approved Elelyso for Gaucher’s disease in 2012.
In 2015, the FDA granted LeafBio Inc. (Mapp Biopharmaceutical, Inc.) Fast Track designation for a plant-made drug called ZMapp for treatment of Ebola virus disease.
Biosimilars
PMPs that are “biosimilar” versions of approved biologic drugs (also known as follow-on biologics or subsequent entry biologics) are subject to laws and guidelines that are being developed by regulatory authorities around the world.
The EMA was the first regulatory authority to establish a standard specifically for regulatory approval of biosimilar drugs. Learn more about the EMA’s guidelines for biosimilar medicines. The EMA has approved 23 biosimilar drugs.
In Canada, the BGTD is developing a comprehensive regulatory framework for biosimilars, and in 2010 released the finalized Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Canada’s first SEB drug was Omnitrope, approved in 2009. Inflectra, an SEB to Remicade (infliximab), was approved in 2015.
In the U.S., the Biologicals Price Competition and Innovation Act (BCPI) of 2009 established an abbreviated licensure pathway for biologics that are shown to be “biosimilar” to or “interchangeable” with an FDA-approved biological (reference) product. See the U.S. FDA Information on Biosimilars website. The FDA has approved two biosimilar drugs to date: Zarxio (filgrastim-sndz), a biosimilar version of Amgen Inc.’s Neupogen (filgrastim), and Inflectra (infliximab-dyyb).