Let the Competition Begin

Yesterday there was a huge court decision that will help pave the way for lower prices biologic medicines to help Americans afford medical treatment.

FDAlawblogger, Kurt Karst, has a great summary of the holding:

ZARXIO is not yet marketed because of the pending litigation in California; however, in a court filing last month, Sandoz said that company “will not launch its biosimilar filgrastim product in the United States until the earlier of April 10, 2015, or a ruling in Sandoz’s favor on Amgen’s Motion [for a Preliminary Injunction].” Well, that ruling has now come out. And Sandoz scored a total knockout!
Judge Seeborg

The decision by Judge Seeborg allows Sandoz’ Zarxio to compete with Amgen’s Neupogen. It will be the first time that a biosimilar has competed in the US.

As Judge Seeborg noted, Amgen has sold Neupogen in the US since 1991, without any competition. Last year Amgen made almost $2 billion from sales of Neupogen in the US.

Biosimilars have been in Europe for years

Data from Europe shows that biosimilars have led to savings on average of 30 percent.

Sandoz’ Neupogen has been in Europe for several years, engendering significant savings to the cost of caring for chemotherapy patients suffering from low white blood cells counts and infections, and for patients undergoing stem cell harvest for transplant. The company presented at the January 7, 2015 FDA meeting that over 7.5 million doses have been injected or infused in patients safely and with the same results as the premium priced branded product by Amgen.

Savings Predicted in the Billions

A PBM (prescription benefit manager) which is a sophisticated purchaser of drugs, may be on the forefront of market acceptance of biosimilars as offering much needed price competition. While predicting the future savings is difficult, Troyen Brennan of CVS Health, is reported by Reuters as predicting that in the US, biosimilars will offer discounts of 40% to 50%, resulting in significant savings for Americans.

This is all good news for cancer patients and their families who often see co-pays for these type of medicines (often called MAbs, monoclonal antibodies) in the thousands of dollars per year. Now Americans will see the benefit that competition brings in lowering the prices of these existing medicines and spurring innovation of new and better ones.

I have a dear friend kept alive on one of these medicines. Her co-pay one year for one of the biologic drug, Genentech’s Herceptin, was $15,000. I once asked her if she would use a biosimilar at a 30% savings, even if it wasn’t exactly the same thing as the drug that was saving her life. She said yes, without hesitation because she wanted to spend more money on her kids than on her medicine.

I look forward to the day when this burden of care is reduced for her, for you, me, for all of us.

Let the competition begin; it is desperately needed here.