FDA Approves First Biosimilar Drug – What’s Next for RA?
On March 6, 2015 the Food and Drug Administration (FDA) approved the first biosimilar drug for use by patients in the United States (see FDA press release). The drug called Zarxio (filgrastim-sndz) is produced by Sandoz and is similar to Amgen’s Neupogen (filgrastim). Both are approved to treat certain kinds of cancers and bone marrow transplants.
Biologic medicines come from living organisms. They are different from chemical medicines in that they contain large and delicate biological molecules such as proteins, must be injected or infused since stomach acids would damage the molecules, and are usually much more expensive than chemical medicines due to development and complicated production costs. Given the high development costs associated with biologics, they are given an extended patent length of 12 years in the United States. When a chemical drug looses its patent protection, companies produce generics that are exact chemical matches. Generics are widely used and are much cheaper than the original drug. Given the complexity of biologics, exact chemical matches are replaced with scientific equivalency meaning that the biologic is similar in action but not exactly the same - thus the name “biosimilar” being used for these drugs (Entine, 2012).1
Some of the most popular RA biologic medicines stand to loose patent protection in the United States in next few years. That patent protection is already lost in some countries. There are a large number of big selling biologic drugs that will loose patent protection. This looming problem is known as the “patent cliff”. According to Calo-Fernandez and Martinez-Hurtado (2012), four RA drugs - Humira, Enbrel, Remicade, Rituxan - are among the top selling biologics in the United States.2
Traditional generic drug companies, along with big pharmaceutical companies, are starting to step into the biosimilar market. The Biologics Price Competition and Innovation Act (BPCIA) of 2009 was built into the Patient Protection and Affordable Care Act (“Obamacare”) and is designed to speed up the process of approval for biosimilars in the United States.
Biosimilars are not without controversy. As Mariah pointed out in a recent article, insurance companies or doctors could substitute originals for biosimilars without notification. Since they are not exact duplicates, biosimilars may not work as well or be as safe as originals. Standards for approval of biosimilars have yet to be established. Because of this lack of standards, the American Autoimmune and Related Diseases Association (AARDA) released a cautionary statement on the heels of the approval of Zarxio. A biosimilar to Enbrel called Etacept, which is produced in China, was approved for use in rheumatoid arthritis in India without clearly defined standards for testing and manufacture (Biosimilar News, 2013).3
The news of biosimilars is of particular interest to rheumatoid arthritis patients since many RA drugs include biologic medicines. Over the next few years, we will likely begin to see a slew of biosimilars for RA hit the market worldwide. The potential savings to patients and insurance companies will competitively drive the market (Entine, 2012).4 Decisions about starting or switching to the biosimilars will need to be made. The efficacy and safety of these look-alike drugs will be questioned. This will also drive large pharmaceutical drug companies to research and develop new drugs for RA in order to maintain a competitive edge.
Below is a list of some of the biosimilar drugs being developed or marketed for rheumatoid arthritis throughout the world. Most major pharmaceutical companies have a biosimilar program.
- Remsima by Celltrion. Approved by European Medicines Agency (EMA) and submitted for review by U.S. Food and Drug Administration.
- Etacept by CP Guojian Pharmaceutical. Approved for use in India.
- SB4by Samsung Bioepsis. Currently under review by the European Medicines Agency (EMA) (Lane, 2015).5
- CHS-0214 by Daiichi Sankyo. Undergoing clinical trials in Japan.
- ONS-3010 by Oncobiologics. Undergoing clinical trials in Europe.
- PF-05280586 by Pfizer. Undergoing clinical trials in the United States.
- AcellBia by BIOCAD. Approved for use in Russia.
- GP2013 by Sandoz. Undergoing clinical trials in the United States.
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