GPhA: Including provisions relating to biologics in TPP agreements is 'premature'

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

The GPhA noted that while implementation of a regulatory approval pathway for biosimilars is ongoing at the Food and Drug Administration, significant disagreement remains about how the law should be implemented and whether further legislation is necessary.

“Given your administration’s position and the uncertainty surrounding the pathway’s implementation by [the] FDA, as well as the critical need to ensure access to safe and affordable medicines in global markets, it is premature to include provisions relating to biologics in any trade agreement,” GPhA executive director Bob Billings wrote in the letter.