Prime Therapeutics welcomes FDA's approval of first biosimilar in U.S., but says more clarity is needed

ST. PAUL, Minn., March 6, 2015 /PRNewswire/ -- Prime Therapeutics LLC (Prime), a non-profit pharmacy benefit manager serving more than 26 million members, today released the following statement responding to the U.S. Food and Drug Administration's (FDA) approval of the first biosimilar to enter the U.S. market.

"Today's U.S. Food and Drug Administration (FDA) approval of Sandoz's Zarxio® to treat neutropenia, a condition affecting about half of all cancer patients, is a major milestone in our country's journey to curb the escalating costs of specialty drugs," said Peter Wickersham, senior vice president for integrated care and specialty at Prime.  "However, it's really only a first step, as we believe a robust market for biosimilars may be in jeopardy if regulators and lawmakers on federal and state levels adopt adverse regulations that create steep hurdles for biosimilar manufacturers."

According to a recent whitepaper Prime sponsored, which was authored by Alex Brill, a health care economist in Washington D.C., biosimilars may only be viable for drugs that can achieve $898 million in annual sales.  If more or less hurdles exist for manufacturers, the threshold could be as much as $1.3 billion or as little as $626 million. As more biosimilars seek approval this year, it's urgent that the FDA decide on naming conventions and avoid unnecessary clinical requirements that serve only to add confusion or costs to the development of biosimilars.  Similarly, state lawmakers need be careful of the unintended consequences of passing substitution laws only for biosimilars labeled "interchangeable" or requiring onerous approvals and paperwork on the part of pharmacists and physicians when switching patients to the lower cost drugs. 

Wickersham added "While we will see some immediate savings from biosimilar blockbusters that have been used for a decade in Europe, our big concern is that a robust biosimilar market will never exist in the U.S. because many biologics being developed today won't meet the desired sales thresholds previously mentioned. As a result, taxpaying citizens will end up saving less than they could have saved. The U.S. has waited long enough for the same access to effective drugs that Europe has used for 10 years. Prime urges regulators and legislators to carefully consider their decisions on this complex issue, or we will miss the full opportunity biosimilars can yield as one way to help solve the unsustainable growth in health care costs."

Biosimilars are drugs made out of organic materials and are highly similar to their biologic reference product, but not an exact copy. It's taken five years for the first biosimilar to be approved under the new pathway provided for as part of the Affordable Care Act.

About Prime Therapeutics
Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime manages pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and delivers medicine to members, offering clinical services for people with complex medical conditions. Headquartered in St. Paul, Minn., Prime serves more than 26 million people. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. Prime has been recognized as one of the fastest-growing private companies in the nation.

For more information, visit www.primetherapeutics.com  or follow @Prime_PBM on Twitter.

SOURCE Prime Therapeutics LLC

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