(Washington, D.C.) – The Trump Administration is taking action to increase access to biosimilars. Congress can take the administration’s lead and entirely eliminate the interchangeability designation for biosimilars.

In response to the new draft guidance, issued yesterday by the Food and Drug Administration, Pharmaceutical Care Management Association President and CEO, David Marin, issued the following statement:

“No other country in the world requires the interchangeability designation for biosimilars. The interchangeability roadblock is yet another example of how manufacturers are manipulating the system to block cheaper generic drugs from getting to patients.

“The FDA’s action will help accelerate biosimilar approvals and that will increase competition. The Trump Administration gets it. Now the responsibility lies solely with Congress to finish the job. Simply put, biosimilars should be interchangeable just like generic drugs. Congress must course correct and eliminate the biosimilar interchangeability designation that is a product of Big Pharma’s agenda to block generics from the market and deny patients access to more affordable drugs.

“Pharmacy benefit managers firmly support biosimilars and generics and prefer them ahead of more expensive brand-name drugs. We urge Congress to take the step to remove regulatory barriers and fight back against drug companies’ war on generics and biosimilars, so that more affordable drugs are available to patients.”