FDA News - July 2016

July 2016, Vol 7, No 6

FDA Regulator Says Too Much Focus Is on PD-1 Drugs

Developing a new type of drug to disable the PD-1 proteins that tumors use to evade the immune system has become the focus of too many drug makers, according to one FDA regulator.

Speaking to Reuters during the annual American Society of Clinical Oncology meeting, Richard Pazdur, MD, Head of the FDA’s Office of Oncology Products, explained that although a few companies have already seen success in developing drugs that target PD-1 proteins, other companies that are in the early stages of developing their own PD-1 drugs may potentially be considered niche indications.

The FDA has already approved the immunotherapies pembrolizumab (Keytruda) and nivolumab (Opdivo), but as many as 5 other companies are developing similar treatments. “People should ask themselves...would we be better off spending those resources into looking at more novel drugs,” Dr Pazdur noted.

Industry leaders, however, argue that with the future of cancer treatments leaning toward combination therapy, having their own PD-1 drugs will give them flexibility in clinical trials.

As Biosimilars Gain FDA Approval, Market Competition Increases

On April 5, 2016, the FDA approved the biosimilar infliximab-dyyb (Inflectra; Janssen Biotech) for multiple indications, including moderate-to-­severe rheumatoid arthritis and chronic severe plaque psoriasis. Infliximab-dyyb is the second biosimilar to be approved. The first biosimilar, filgrastim-sndz (Zarxio), was approved in March 2015.

Biosimilars must be shown to be highly similar, although not identical, to an already approved biologic (reference) drug. There can be no clinically meaningful difference in safety or effectiveness between the biosimilar and the reference drug.

As many biologic patents expire over the next few years, biosimilars have the potential to enter the market and impact drug costs. Although only recently approved in the United States, biosimilars have been available in Europe since 2006 and often cost less than 33% of the price of biologics (Hede K. J Natl Cancer Inst. 2015;107:djv191).

That trend appears to be carrying over to the United States. When Novartis launched filgrastim-sndz, a biosimilar to Amgen’s filgrastim (Neupogen), it did so at a 15% discount. As other biosimilars enter the market (eg, Apotex’s filgrastim biosimilar, Grastofil, is expected to be approved by the FDA in 2016), prices may decrease even further.

With applications submitted by Apotex and Sandoz for biosimilars to pegfilgrastim (Neulasta) as the reference drug (both expected to be accepted in 2016), increased competition in the oncology drug space is likely to drive down costs.

Other oncology biosimilars that are expected to be approved this year include erpoetin alfa (Retacrit; Pfizer), which is a biosimilar to Amgen Epogen and Janssen Procrit.

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