Industry Experts: Naming and Labeling of Biosimilars

The naming and labeling of biosimilar and biologic products has previously caused controversy throughout the industry. The FDA officially released a finalized naming and labeling guideline in January 2017, and started to implement the new approach in November 2017.

The guideline constitutes the non-proprietary name of approved biosimilars and biologics to include a 4-letter suffix, devoid of meaning. In addition, the policy requires previously approved reference products to include the suffix as well; however, to date, no biologic approved prior to the release of the finalized guidance has been retroactively amended.

In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, Laura Sim, JD, senior counsel at Amgen, and Vishal Gupta, JD, partner at Steptoe & Johnson LLP, discussed various naming and labeling considerations to take into account.

Sim began her presentation by noting Amgen’s positive opinion of the FDA’s naming regulations because it “promotes patient safety and success of the market and will also enhance pharmacovigilance and the traceability of a drug.”

An important area to watch going forward in the process will be the naming of any potential interchangeable products, as well as how the FDA will address the addition of suffixes to already marketed products. Amgen, she said, has recommended a few key action items to the FDA to ensure the smooth implementation of suffixes to postmarketed products, such as:

• Allowing a 5-year window for manufacturers to transition to new names
• National Drug Code numbers should be retained
• The Purple Book should be utilized during the transition

Gupta then led a discussion around labeling practices for biosimilar medicines. There has been some litigation around what a biosimilar medicine should or should not legally include within its label. The FDA put out a draft guidance document in March 2016 specifying that a biosimilar drug label must contain:

• A biosimilarity statement
• The reference products proprietary name when discussing clinical data
• The biosimilar proprietary name when discussing indications and usage

Notably, the label guidance does not include the requirement of an interchangeability statement, biosimilarity study data, or statements about any extrapolation of data. “Going forward, I expect that the final guidance will be pretty consistent with the draft guidance the FDA has issued,” said Gupta.