Biotech-Driven Change in Prescription Drugs

By Sandy K. Johnson

Technology is revolutionizing our lives, including the prescription drugs that help keep us ticking.

Medicines once made of small molecules are giving way to new high-tech drugs made from living organisms, or biologics. These pharmaceuticals are gaining a growing share of the prescription drug market.

* In 2002, biologics generated $46 billion in revenue.
* By 2017, biologics are forecast to reach $221 billion, or nearly 20% of the total global pharmaceutical market.

Viewed another way, the federal government approved 44 new drugs in 2014; more than a third were biologics.

Regulation and Prevalence of Bio-Tech Drugs

From start to finish, the timeline to develop a new drug and push it through the government approval process takes about 10 years.

From the lab, a new drug goes through animal trials and then three phases ofclinical trials in humans – all under stringent FDA oversight. Eventually, there are scientific hearings that are open to journalists and hundreds of pages of regulatory documents to wade through. The process for large-molecule biologic therapies is similar to small-molecule conventional drugs.

The new wrinkle is biosimilars, which are “similar to” the new bio-tech drugs – but not in the way that generic drugs are exact copycats of conventional drugs. Europe’s equivalent of the FDA has approved 20 biosimilars so far and just one – Zarxio – has been approved in the United States.

What's Next? Biosimilars: The Future of Biosimilar Drugs in the U.S

The first biosimilar drug therapy won FDA approval in March and is launching in U.S. markets this fall, finally moving the United States down a path taken by European nations a decade ago.

A biosimilar is “highly similar” to the drug that it copycats. The best analogy is a generic version of a conventional small-molecule drug, but biosimilars are really a different ball game, as two experts said in a conversation with NPF.

The newly approved biosimilar, Zarxio, is the “highly similar” alternative to the existing anti-infection drug Neupogen. Its maker said Zarxio will be sold at a wholesale price of $438 for a single dose, compared with $516 for the brand-name drug. That is a 15 percent discount, but both prices are steep – which is one of the controversies about these new complex drug therapies.

But cost, too, is in the eye of the beholder. The cost of Zarxio is “relatively inconsequential in the grand scheme” of overall cancer treatment costs, said Michael Kleinrock, director of research development for IMS Institute For Healthcare Informatics. Kleinrock joined Dr. Jeremy Greene of Johns Hopkins University in a webinar for NPF.