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Manufacture Biosimilars

Biosimilars: the Big Picture

In 2010, the Affordable Care Act (ACA) established an abbreviated regulatory pathway for biosimilars. The pathway was based on regulations included in 2009 legislation on biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA essentially does for large-molecule biosimilars what the 1984 Hatch–Waxman Act did for small-molecule generics, and the regulatory pathway is widely expected to speed the development and marketing of biosimilars in the US (1). In March 2015, the FDA approved Zarxio (biosimilar filgrastim), which is the first product to successfully complete the new regulatory pathway.

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About the Author

Joshua Cohen

Turned off by his family’s predilection for the medical doctor profession – following in the footsteps of the family patriarch all four siblings became physicians – Joshua Cohen obtained a degree in economics. “However, as a child growing up I was obviously subconsciously affected by all that health talk around the dinner table, as I specialized in health economics,” says Joshua. Interested less in the clinical side of health and more in the economic aspects, he wants to find out whether what the physicians are prescribing is really worth it and how to facilitate patient access to medically necessary biopharmaceuticals. His research has run the gamut from the ethics of healthcare distribution, to personalized medicine, to neglected disease drug development.

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