PhRMA, BIO Push for Labeling Distinctions Between Biosimilars

Two major trade groups are pressing the FDA to draw sharp labeling distinctions between biosimilars and the products they mimic.

In a joint petition to the FDA dated Dec. 22, PhRMA and BIO ask the agency to mandate that all future biosimilar labeling include the following:

  • A disclosure that the product is a biosimilar and identify the reference product;
  • A description of the nonclinical and clinical data used to back approval;
  • A description of the basis of approval for each indication; and
  • A statement on whether the product also has received an interchangeability designation from the FDA for the reference product.

While the FDA has yet to issue guidance on the subject, PhRMA and BIO note that the labeling for the lone biosimilar approved thus far — Sandoz’s Zarxio, which was approved last March — did not contain the requested elements.

Toward that end, the petition also asks the agency to “promptly issue” draft guidance on the subject, given that “physician labeling is the central mechanism through which FDA and manufacturers communicate authoritative information for safe and effective prescribing of biologics.”

Lastly, the petition asks the FDA to incorporate these requested policy changes into the guidance document.

A spokesman for BIO says that the group does not believe the requested strict labeling distinctions run counter to its member-companies’ interests. Rather, he contends that without the availability of “full, transparent and distinct labeling information,” many physicians “will lack confidence to prescribe biosimilars to their patients.”

A PhRMA representative declined Jan. 8 to expand on the petition.

Read the petition here: — Cameron Ayers


$1,097 $847


Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar CD, A Biosimilar by Any Other Name — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.