Today the FDA announced a new education and awareness campaign that will help physicians better understand the world of biosimilars.

First, what is a biosimilar? Biosimilars are complex therapies that are similar to biologicals – such as cancer therapies.  They have the potential to facilitate greater competition and thereby reduce costs, similar to what generics have done for the small molecule market.

In a blog post this week, FDA Commissioner Scott Gottlieb announced the new initiative, saying “FDA has developed educational materials to help health care providers gain a better understanding of these important products and the approval process they undergo.”

Physicians are key to making sure that FDA approved biosimilars (of which there are now seven) are prescribed and utilized in a way that facilitates competition.

If physicians have questions or concerns about the safety standards of FDA approved biosimilars, they may be hesitant to recommend them to patients.  Hence, FDA’s education campaign.

According to the announcement, the campaign will have three broad goals:

  • Provide the basic definitions of terms like: biological product, reference product, biosimilar, interchangeable; and other terms to facilitate understanding of the relationship between biosimilars and their reference products;
  • Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products; and,
  • Provide easily accessible information about the data and information FDA reviews to determine biosimilarity, and how to find more resources.

This is the latest step the agency has taken to facilitate a competitive pharmaceutical marketplace.  Since taking over the helm of the FDA, Commissioner Gottlieb has aggressively pursued a course of action that promotes market competition.

Early in his tenure he developed a generics action plan designed to facilitate a speedy generic drug development and review process.

In addition, the agency has been touting recent successes under the Generic Drug User Fee Act, which helps provide FDA with the resources it needs to facilitate the review of generic drug applications.   See this recent chart tweeted out by Dr. Gottlieb.

Source: Food and Drug Administration 

While some will view these measures as positive steps, others may not.  Advocates in favor of more aggressive measures to address drug pricing issues may view this as a distraction to other steps they would prefer the agency take.  For the time being, the FDA seems set to stay on this course.

Will this education campaign help move the needle on biosimilars? Let us know what you think at

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Bobby Clark is Of Counsel at Winning Strategies Washington, a DC-based government relations firm, and a co-founder of Concordis: Strategy and Analytics. He previously served as a senior health policy for a senior member of the Energy & Commerce Committee, and most recently for the Department of Health and Human Services during the Obama administration.

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