How to Save a Big Money Blood Cancer Franchise

One month ago, the FDA approved the first so-called biosimilar for the US market. This move on the part of a sometimes slow-witted regulatory agency was seen as a victory for consumers—no more paying through the nose for biologic drugs! Biosimilars, being like generics, will bring costs down and create some competition in the multi-billion dollar bio-pharmaceutical marketplace!

The best example was to be Rituxan, the anti CD20 monoclonal antibody so familiar to lymphoma patients, a drug that may be saddled with plenty of problems, but is a certified game-changer in cancer treatment. Rituxan's total revenues are mindblowing: Since 1997, this first-in-class cancer treatment has brought Roche somewhere around $40 billion.

-- Weddings in the United States are a $40 billion industry.
-- With $40 billion, the International community just bailed out Ukraine.

Costs vary widely, but a full course of Rituxan could cost around $60,000. Even if a biosimilar could cut that in half, it would amount to significant savings.

Roche, however, is not about to watch competitors devour its multi billion dollar blood cancer franchise simply because their patent on the drug is set to expire. They can't themselves make a biosimilar, so what do you do?

The Magic of Branding

For several years, Roche has been developing a monoclonal antibody that used to be known as GA101 but is now called Gazyva. In 2013 the FDA approved it for chronic lymphocytic leukemia. All the while, Roche has been launching head-to-head clinical trials pitting Gazyva against Rituxan in some high-rent subtypes, including

• Indolent non-Hodgkin's lymphoma
• Previously untreated diffuse large b-cell lymphoma
• Relapsed or refractory diffuse large b-cell lymphoma.

At least seventeen separate trials, all with one goal in mind: cannibalize that pesky Rituxan. Use the low-lying fruit of the clinical trial endpoint world, progression-free survival, and watch Rituxan get its ass kicked.

[Progression free survival, PFS, is a measure of the length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse, according to things like scans. Longer progression free survival does not mean the patient lives longer than someone whose progression free survival period was shorter. There is no correlation between PFS and actual survival times.]

If Roche can convince your doctor that Gazyva is better for you than a Rituxan biosimilar, not only will they have snatched revenues out of the hands of their competitors, they will have also continued to support that blood cancer franchise, now to the tune of roughly $41,000 per Gazyva treatment.

But for Roche that's not even the best part. The best part shows big pharma doing what it does best—no, not developing worthwhile drugs for humanity—rather, effectively marketing those drugs to a confused and frightened public. They do it with nothing more than labels.

Remember that incredible breakthrough treatment, the monoclonal antibody Rituxan? It is being re-branded now as a 'First Generation' anti-CD20 monoclonal antibody. So last generation, that Rituxan.

Gazyva, meanwhile, is 'Next Generation'.

And how about those Biosimilars we heard so much about, aren't they new and hip?

Sure. They were. Until Gazyva, the 'Biobetter.'