On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines.

 

“We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services,” said FDA Commissioner Scott Gottlieb. Regarding biosimilars, the Roadmap emphasizes that FDA will focus on making the process for developing and approving biosimilar drugs more efficient, and promoting cost reductions through increased competition:

 

“As part of these efforts, we will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs. These policies will be part of a new Biosimilar Innovation Plan (BIP) that we will advance over the coming year.

 

As FDA improves its policies related to new product development, it is imperative that we balance increased access to lower-cost, generic medicines and biosimilars with the benefits of new product innovation. Competition plays a key role in reducing costs of products like prescription drugs, and enabling broader access to beneficial medicines. Greater access to effective drugs also helps advance the public health and lower overall health care costs by improving health outcomes and reducing the cost and burden of disease. Enabling access to safe and effective innovation that can promote better health is a critical part of FDA’s mandate.” 

 

Read the 2018 Strategic Roadmap here.