FDA Strategizes to Step Up Introduction of Lower-Cost Drugs and NGS

Samantha Hitchcock
Published: Tuesday, Jun 19, 2018
Scott Gottlieb, MD

Scott Gottlieb, MD

The market for biosimilar introduction is “extremely unstable,” but the FDA is working to ease the launch of more affordable cancer medicines, both biosimilars and generics, with a strategy that includes an attempt to reduce anticompetitive behavior, according to Scott Gottlieb, MD, commissioner of the FDA.

Gottlieb discussed the competitive landscape for oncology agents and how it is affecting the introduction of new medicines in a keynote talk at the 2018 Community Oncology Conference that the Community Oncology Alliance held in National Harbor, Maryland, in April.

There are numerous approval and marketing challenges for makers of biosimilars who seek to challenge the dominance of branded drugs. Since September 2017, 2 biosimilars have received FDA approval specifically for treatment of cancer and 2 for conditions related to cancer. Gottlieb said that pace has been a pleasant surprise. “I always thought it was going to be a slower-developing area with more hurdles to get over, but we’re right on track,” he said.

Although the FDA has no regulatory power over the prices set by manufacturers, distributors, and retailers, Gottlieb said, the FDA’s commitment to encouraging biosimilar and generic competition in the cancer drug marketplace has the potential to lower costs and improve patient access to available cancer care.

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