Viewpoint: We need to speed up biosimilar drug approval process

3-26-2019 gaining momentum on the road to accessible biosimilars
Image: Stella Wooder

Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. Biosimilars now have the potential to create substantial savings on complex biologic drugs.

As we write this, the FDA has approved a total of 17 biosimilars.


This stands in stark contrast to how these medicines have fared in many other countries, where biosimilars are widely acceptedbroadly used, create substantial savings for health care systems, and expand access for patients.

Recent efforts to streamline the regulatory process, such as the FDA’s Biosimilars Action Plan, are steps in the right direction. But they aren’t enough to ensure that these medicines reach patients. We need a multipronged approach to improve post-approval uptake that includes expanding educational programs and encouraging good-faith efforts to efficiently and fairly resolve patent disputes.

Related article:  Viewpoint: At-home test detects cervical cancer early. It should be available to all women


Biologic medicines that represent approximately $100 billion in sales are expected to be off patent by the year 2020. That represents a substantial opportunity for biosimilar medicines to create savings for the U.S. health care system. The question is, will we be able to act sooner rather than later to make a difference for patients today?

Read full, original post: Biosimilar approval and adoption in the U.S. needs to be expedited

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