BREAKING NEWS: Deal Is Reached on TPP

Biosimilar News

It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP).

As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to provide for biologics. U.S. negotiators originally sought to maintain the 12 years of data exclusivity for biologics provided by the BPCIA, while other countries, including Australia, sought a much shorter exclusivity period. Today’s announced agreement includes a compromise under which biologics data will be protected for at least five years.

The agreement still needs to be ratified by Congress, although it passed a bill earlier this year permitting the President to negotiate the TPP with “fast-track” authority. It is possible that there would be stiff opposition to this and other provisions.

We will continue to post updates as this issue develops.

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