It was recently announced that Etacept was being launched in India by the generic drug company Cipla as a “biosimilar” to Enbrel (Etanercept). This new biological drug is designed to treat rheumatoid arthritis and other rheumatic conditions and is being manufactured by China-based Shanghai CP Guojian Pharmaceutical Company Ltd. It is supposed to cost 30% less than Enbrel. The approval of this biosimilar in India is not without controversy as biotechnology companies are complaining that Cipla did not follow the standards for approval (see this article).
In the United States, patent exclusivity for biological drugs is set at 12 years. This is designed to protect the expensive and time consuming processes involved in developing and testing these complex biological treatments. However, there is an approaching “patent cliff” (see this excellent article on biosimilars). Of all biologicals used for a variety of diseases, Humira, Enbrel, Remicade, and Rituxan are among the most profitable biologicals on the market. These drugs will lose their patent protection in the next few years. Once the patent cliff is reached, large pharmaceutical companies stand to lose billions of dollars in sales (see this article). 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. Large generic drug manufacturers are beginning to ramp up to enter the biosimilar market
Over the next few years, we will likely begin to see a slew of biosimilars for RA begin to hit the market worldwide. The potential savings to patients and insurance companies will competitively drive the market (see this article). 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.