New Process for FDA Approval of Biosimilars

Wall Street Transcript

67 WALL STREET, New York - September 13, 2013 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Biotechnology and Pharmaceutical Investing - Orphan Drug and Biologics Manufacturing - Oncology Drug Development

Companies include: Amgen Inc. (AMGN), Celgene Corporation (CELG), Onyx Pharmaceuticals Inc. (ONXX), The Coca-Cola Company (KO), International Business Machine (IBM), Celldex Therapeutics, Inc. (CLDX), Immunomedics Inc. (IMMU), Keryx Biopharmaceuticals Inc. (KERX), Pluristem Therapeutics, Inc. (PSTI), NPS Pharmaceuticals, Inc. (NPSP) and many others.

In the following excerpt from the Biotechnology and Pharmaceuticals Report, an expert analyst discusses the outlook for the sector for investors:

TWST: Let's jump back to an earlier conversation about the FDA. Are they becoming more accommodative?

Mr. Peaker: They certainly are trying to be more accommodative. There are a number of new developments at the FDA that people are just waiting to see that some of them, how they play out. I mean, one big area, it is the biosimilar front, which is kind of the generic equivalent for biologics. Not a true generic, but that's been something that's been an uncertainty for a long time, exactly how biosimilars are going to be viewed and how exactly they're going to be analyzed and how to bring one to market. And even though we are still in the early stages of this process, the FDA has had a lot of clarity, and we've seen a lot of companies make some substantial investment into the biosimilar area. So that's one area of FDA.

The other thing that the FDA has done is they've tried to help further identify drugs that are more significant, let's say, than an incremental drug or the drug that's more than an incremental improvement on something existing, and they've come out with a breakthrough designation. Basically the idea is that if you can identify a drug as being higher priority than others, then the FDA is going to allocate more resources and working closer with the sponsor to make sure that the drug is developed as fast as reasonably possible and that studies that are being conducted are satisfactory for the agency...

For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Rates

View Comments (0)