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FDA Issues Final Guidelines To Make Interchangeable Biosimilars More Easily Available

FDA Issues Final Guidelines To Make Interchangeable Biosimilars More Easily Available

The FDA issued final guidelines Friday concerning the interchangeability of biosimilars with biologics with an intention to make the former easily available to patients, just as how generics are used for branded drugs.

What Happened

The FDA's latest guidelines outlined the studies a company making a biosimilar — a copycat version of the pricey biologic — should conduct to obtain the interchangeable designation.

A biologic can cost up to hundreds or thousands of dollars for some chronic conditions.

"This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement," the FDA said.

Companies are advised to conduct switching studies to determine whether switching between a biologic and interchangeable biologic will alter the efficacy and safety of the treatment.

Why It's Important

The federally approved Biologics Price Competition and Innovation Act of 2009 paved the way for an approval pathway for biologic products.

"This pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, by increasing access to life-saving medications and potentially lowering health care costs through competition," FDA Commissioner Norman Sharpless said in a statement.

While there are no interchangeable biosimilars on the market today, 19 biosimilar drugs have been approved. Therefore, pharmacies can't automatically substitute a biosimilar for a biologic.

With the FDA issuing guidelines to simplify the process, things could change soon.

Boehringer Ingelheim is the only company, which has applied for a biosimilar with the interchangeability designation, for AbbVie Inc (NYSE: ABBV)'s Humira, according to Endpoint News.

Soon, interchangeable biosimilars to insulin biologics may be coming to be the market.

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