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  • Writer's pictureAIM Team

Final TPP agreement draws ire from both sides over biologics exclusivity

The pharmaceutical industry is not enamored of the recently concluded Trans-Pacific Partnership recently signed by President Obama.

From Regulatory Focus

Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.

The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the US, Australia, New Zealand, Canada, Japan and Malaysia. All parties still need to agree on the final language of the deal.

Trade representatives from the US and Japan favored a longer period of protection – up to 12 years — while others, such as Australia, expressed fears that delaying the entry of biosimilars for that long would raise costs.


Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) issued statements of disappointment over the compromise, claiming it will prevent industry innovation.

“The [US] Congress set 12 years as the appropriate period to both foster innovation and provide access to biosimilars in a reasonable timeframe,” BIO President and CEO Jim Greenwood said. “While the TPP agreement will not impact the US data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients.”

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