Trade Deal Could Effect Cost and Regulation of Biosimilars

Modern pharmaceutical enterprise production lineFor five years, the United States, along with 11 other countries have been negotiating the terms of the Trans- Pacific partnership, a trade deal between multiple Pacific Rim countries. In this deal, there is discussion on the pricing and regulation of drugs. 


Patents play a key role in the biosimilar industry. Many of the biosimilars in the drug pipeline are awaiting FDA approval are copies of drugs that have expired or expiring patents. In an interview with Vox, Amy Kapczynski, Yale Law Samsung Bioepis Courts Investment on Nasdaqprofessor and global health researcher discusses the effect of patent laws. She states, “We know from experience that more expansive patent laws end up reducing the availability of generic medicines.” From leaked draft she finds, “the TPP contemplates expanding countries’ obligations to grant patents to pharmaceutical companies.” This would mean that each individual country would have to set more stringent patent laws, which would reduce any potential flexibility in policy.

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