Prime Therapeutics Urges FDA to Keep Consistent Naming Conventions for Biologics, Biosimilars

Prime Therapeutics, LLC (Prime) has submitted comments to the FDA in support of two citizen petitions on the naming of biosimilar drugs.

Biosimilars are medically equivalent versions of biologics, used to treat complex illnesses such as cancer. The citizen petitions were filed in 2013 by the Generic Pharmaceutical Association (GPhA) and Novartis.

The petitions urged the FDA to adopt a naming system where each approved biosimilar is assigned the same non-proprietary name as the approved reference biologic.

“How biosimilars are named matters because it directly affects consumer access to these treatment alternatives," said Eric Elliott, chief executive officer at Prime. “Today, there are very few substitutes to expensive specialty biologic medicines that treat complicated illnesses. As more of these medicines become available, having biosimilars that share a non-proprietary name with the branded biologic product will help doctors easily substitute the highly similar, lower cost medicine just as we do for generics now.”

As specialty medicines drive increases in overall spending on pharmacy, efforts to bring safe biosimilars to market in the US are extremely important. Prime predicts specialty drug costs will consume 60% of total drug spending by 2018 — today they account for 20% of drug costs.

Biosimilars have been successfully used in Europe for many years.

According to Joseph P. Fuhr, Jr, MD, a professor of economics at Widener University, biosimilars are, on average, 30% cheaper than branded biologics.

Prime joins GPhA and Novartis in opposition to the position taken by the Pharmaceutical Research and Manufacturers of America (PhRMA), calling for the assignment of a non-proprietary name that is unique and distinct from the reference product. Prime, a pharmacy benefit manager privately held by 13 not-for-profit Blue Cross and Blue Shield plans, believes the changes called for by GPhA and Novartis would help increase patient safety, prevent prescriber confusion, and help keep medicine more affordable.

Shared non-proprietary names have been used in the US for chemical drugs. They’re also consistent with the World Health Organization’s policy and the naming convention that has been in place in Europe for more than 50 years.

“It’s our hope that by adding our voice in support of naming consistency, the FDA will choose to maintain the current naming structure they’ve successfully used for other drug approvals and ensure the development of a robust biosimilars market in the US,” said Elliott.

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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 25 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