QDIS Blog

The FDA and Biogenerics

by Ed Vawter @ 8:09 am. Filed under FDA

One of the major upcoming hurdles for the FDA will be approval of biogenerics (aka generic biodrugs). These are biologics that will soon be coming off patent such as human growth hormone Omnitrope (somatropin) from Sandoz (generics division of Novartis) and Valtropin (somatropin) from BioPartners GmbH. Currently, there is no process for approval of these by the FDA. Unlike small molecule drugs, these compounds are complex proteins with a complex manufacturing process. I personally think (at least initially) this needs to be handled on a case-by-case basis but with a well-thought out process for doing so. Small changes in a proteins structure can have a major impact on the biological activity. Also the process by which the biologic is produced has a major impact on the overall quality. Use of yeast is different from the use of e.coli to produce a given compound.

There are 11 biologics who’s patents have either expired or will expire before the end of 2006. I good article in C&EN listed these back in Sept 2002.

The market size for biopharmaceuticals is approximately $20 billion and continues to have strong growth. Estimates for biogenerics is less well known but is estimated to be $2 billion in 2010 and will grow to $12-15 billion in 6-8 years after that. The US is already behind other countries such as Australia and the EU with regard to approving biogenerics. This issue is particularly important for the US healthcare system since the generic market was developed as a way to control costs and these are some of the most costly pharmaceuticals. The average daily cost for a small molecule drug is $1.66 whereas for biologics at is $45 per day. (ref: Kathleen Jaeger, president and chief executive officer of Generic Pharmaceutical Association in Generics in 2006 in Pharma & Bio Ingredients Jan/Feb 2006, p44).

According to Crystal Rice, spokeswoman for the FDA’s Center for Drug Evaluation & Research the FDA expects to release guidance documents soon. “We can’t say exactly when it will be ready, but we certainly plan for this calendar year.” This was from an article in Drug Topics in 2004! It’s been over two years now and still no guidance documents on this have been released.

A federal judge in the District of Columbia has recently ordered the FDA to act on Sandoz’s application. Judge Ricardo Urbina called the delay “egregious” and said the FDA must give some kind of response. Sandoz is already marketing Omnitrope in Germany and Austria as well as Australia.

Here is a list of some good recent articles covering this area:

Biogenerics: US to finally follow EUs lead? - Pharmaceutical Business Review
Sandoz Wins EU Approval, US Progress for Biogeneric Product - PharmTech
Regulators struggle with generic biodrugs - The Boston Globe:

TAKING BIOLOGICS FOR GRANTED? TAKINGS, TRADE SECRETS, AND OFF-PATENT BIOLOGICAL PRODUCTS
Moving Towards Biogenerics in the U.S. - Pharma & Bio Ingredients SSRN-The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement by Gregory Mandel

Technorati Tags: biogenerics, FDA, somatropin