By Anna Rose Welch, Director, Cell & Gene Collaborative
If there is one thing we’ve learned in the biosimilar industry over the past 12 years, it’s that a successful biosimilar market is contingent upon a highly involved and supportive government. In fact, if you were to look at the greatest biosimilar successes in countries abroad, you would likely track these triumphs to laws and guidelines put in place by a proactive government.
In the U.S., where uptake remains behind Europe, 2018 will clearly go down in the books as the “Year of Biosimilar Policy.” We saw a number of critical, biosimilar-friendly changes (or proposed changes) to Medicare Part B and Part D, as well as passage of the Biosimilars Competition Act of 2018 and resurgence of the Creating and Restoring Equal Access to Equivalent Samples Act of 2018 (CREATES Act). There are also whispers about the U.S. Department of Health and Human Services (HHS) making changes to rebate models across federal programs.