DISQUS

jason · 2 years ago

I think you have to allow for a few differences between a scale-up issue like this and the general debate around biosimilars.

1. Scale-ups are produced with cells cloned from the original production system, biosimilars are not.

2. Originating companies may hold process patents and other know-how that the biosimilar company has to invent around.

3. Biologics have a wide range of complexity. Some are shorter, more simple and without complex sugars, some are not.

Lumping all biologics together (HGH vs. Myozyme) doesn't address these issues. Unless you think that the differences between the two is not that great.

Scott · 1 year ago

You are absolutely correct in that the biotechnology industry wants to have it both ways. I disagree slightly with Jason's characterization that lumping all biologics together (HGH vs. Myozyme) doesn't address these issues. Last year, on March 26, 2007, Novo Nordisk A/S sent one of its executives, Inger Mollerup, Vice President for Regulatory Affairs to testify before Congress. Mollerup said "While some of the best known peptide molecules - like insulin - can be largely characterized with today's technology, we do not yet have the tools and models that enable us to predict safety and efficacy from that characterization without undertaking human clinical trials."

In effect, Mollerup told Congress that even those biotech medicines (insulin) whose sequence is completely characterized is insufficient to predict safety and efficacy. Of course, in 1997, the geniuses in Congress passed the Food and Drug Administration Modernization Act (FDAMA) of 1997. The FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the FDA certified drugs containing insulin, in effect saying that batch testing was not a necessity for that drug (presumably because its a relatively simple molecule), and the pharma-biotech industry has abused this privilege. In 2003, Eli Lilly and Company received FDA approval to outsource the manufacture of at least some of its blockbuster Humalog and Humulin to third-party Hospira, Inc. Just a few days ago, Lilly announced it was closing the plant in Indianapolis that made Humalog and Humulin and would concentrate production at its other facilities in Puerto Rico and France, but would also use third-party contract manufacturers to a greater extent. Anyone who uses insulin knows that part of the unpredictability of using it is derived from sloppy manufacturing processes, so while the Genzyme issue affects a larger-molecule protein, the rules need to be enforced even for the simplest of molecules such as insulin -- they aren't the same, but the dysfunctional regulatory environment which governs most biotechs by the Public Health Services Act, but grandfathers insulin and HGH under the Federal Food, Drug & Cosmetic Act need to resolve these issues. Someone is going to be hurt otherwise, but we need Congress and the regulators at the FDA to address these issues, and the FDA mistakenly believes that the user fee act means they work for the pharmaceutical industry.

But if the industry is to have any shred of credibility