FDA Begins Approval Process for Biosimilar Drugs
On Thursday, FDA accepted an application from Sandoz seeking approval for a copycat version of Amgen's biologic drug Neupogen, marking the first time the agency has agreed to consider approval for a biosimilar, Reuters reports. Neupogen is used to lower the rate of infections in cancer patients undergoing chemotherapy (Hirschler, Reuters, 7/24). According to the Washington Post's "Wonkblog," the biosimilar is currently being sold in 40 countries, and it could gain FDA approval as soon as 2015 (Millman, "Wonkblog," Washington Post, 7/25).
Biologics are developed from living cells, which makes the drugs both costly to develop and impossible for generic drugmakers to manufacture exact replicas. However, generic drugmakers can develop more affordable versions of the drugs, called biosimilars, that are close enough to biologics to function in the same manner (Reuters, 7/24).
There is a small but growing market overseas for biosimilars, with projections estimating that the global market for the drugs will increase from $1.3 billion in 2013 to $36 billion by 2020. In addition, Express Scripts estimates that because of the lower prices of biosimilars, the U.S. could save $250 billion in health care spending over the next decade if it adopted biosimilars for just 11 biologics.
However, no biosimilar drugs are currently available on the U.S. market because regulators in the country had not, until Thursday, finalized an approval process for the medications. According to "Wonkblog," the Affordable Care Act included a provision designed to create an approval process for biosimilars, and FDA's decision to accept Sandoz' application marks the "first step" toward putting such drugs on the U.S. market ("Wonkblog," Washington Post, 7/24).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.