Supreme Court Ruling Could Hasten Biosimilars Approval

By: | Jun-16-17

The Supreme Court ruled unanimously this week in a decision on biosimilar medications, a ruling that could save patients and the healthcare system billions of dollars. In Sandoz v. Amgen, the Court held that a federal statute should not be interpreted to delay marketing of each new biosimilar product by an additional six months.

The Supreme Court’s decision backs up a legal brief NACDS filed in the case, which opposed the additional six-month delay in marketing biosimilar products. NACDS’ brief, which was filed jointly with Pharmaceutical Care Management Association and the Healthcare Supply Chain Association, argued that delaying each new biosimilar product by an additional six months is contrary to congressional intent to promote access to biosimilars when it enacted the Biologics Price Competition and Innovation Act.

NACDS also voiced support for policies that boost increased use of biosimilars in statements last week to the Senate Finance Committee and the House Ways and Means Committee as they reviewed the FY2018 Department of Health and Human Services’ budget. NACDS stated, “NACDS supports policies that promote confidence in and encourage increased use of more cost-effective biosimilar medications.” NACDS noted in the statements that “a 2014 report published by the Rand Corporation found that the use of biosimilars could provide a $44.2 billion reduction in direct spending on biologic medications over the next ten years.”

NACDS is working with a coalition of associations and companies to advance the development and marketing of biosimilar drug products, with the goal of improving access and lowering costs for pharmacies and patients.

2017-06-16T08:04:18+00:00Jun-16-17|Categories: Article|Tags: |