On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018. FDA noted that, among these policy areas, it planned to “leverage innovation and competition to improve health care, broaden access, and advance public health goals.” In this regard, FDA plans “to take new steps in 2018 to make the process for developing and approving biosimilar drugs more efficient. As part of these efforts, [FDA] will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs.” According to FDA, these policies will be part of a new Biosimilar Innovation Plan (BIP) that will be advanced in the coming year.
The Roadmap also addresses the availability of biosimilars: “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.”