With 20th Biosimilar Approval, FDA Celebrates Success

June 20, 2019

Biosimilars Team

With the announcement of Kanjinti (trastuzumab-anns) on June 13, 2019, the Food and Drug Administration (FDA) has approved a total of 20 biosimilars for nine different reference products since 2015. In an FDA Voices piece marking this milestone, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, and Peter Marks, MD, PhD, Director, Center for Biologics, Evaluation and Research, reflected on the success that the 20th biosimilar approval represents.

Biologics currently account for approximately one third of all new therapies approved by the FDA. They also represent almost 40% of all prescription drug spending; 70% of the growth in drug spending from 2010 to 2015 was attributable to biologics. Woodcock and Marks explain that biosimilars play a very important role in countering this trend, much as generics have helped make essential small molecule drug therapies available to patients at a reduced cost.

In 2010, Congress authorized an abbreviated licensure pathway through the Biologics Price Competition and Innovation Act (BPCI Act) for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. One of the goals of the BPCI Act was to create greater competition in the medical marketplace that would increase treatment options for patients and lead to less expensive alternatives.

As Woodcock and Marks note, the United States now has at least one biosimilar approved for Avastin, Enbrel, Epogen/Procrit, Herceptin, Humira, Neulasta, Neupogen, Remicade, and Rituxan—each among the top selling biological drugs. Three biological reference products (Avastin, Epogen/Procrit, and Rituxan) have one approved biosimilar. Three (Enbrel, Neulasta, and Neupogen) have two approved biosimilars. Two (Humira and Remicade) have three approved biosimilars. Herceptin has five approved biosimilars.

The FDA has taken a number of steps to ensure the ongoing success of biosimilars. For example, the Biosimilars Action Plan released in 2018 is focused on increasing regulatory clarity through guidance; educating patients, clinicians and payors about biosimilars; and reducing gaming of the FDA requirements or other attempts to unfairly delay competition. A variety of detailed guidance documents for industry have provided greater clarity to manufacturers on scientific and regulatory considerations for the development of biosimilars.

The FDA Voices piece also reiterates concern about the development of mandatory product-specific standards by non-governmental organizations such as the U.S. Pharmacopeia (USP). Although manufacturers comply with USP monographs for many FDA-approved drugs, requiring biological products (including biosimilars) to adhere to a monograph could hinder progress without offering additional quality assurances, as discussed in a recent CDER Conversation piece. The FDA does support the development of voluntary standards by USP and other consensus standards organizations.