Is the Concept of Biosimilars Feasible?
With the introduction of the Biologics Price Competition and Innovation Act that was included in the Patient Protection and Affordable Care Act, drug prices have been changing. This legislation allows companies to produce medications that are similar to brand drugs and use these medications interchangeably. There must be clinical evidence that the biosimilar product produces the same medical result as the brand medication.
In March of 2015, Zarxio, a biosimilar for Neupogen, was the first biosimilar medication approved by the FDA. These medications are granulocyte colony stimulating factors (G-CSF) that treat Neutropenia. A PBM estimates that the introduction of this biosimilar could reduce US Drug costs by $5-7 billion over the next ten years. The release of Zarxio has now been put on hold due to the U.S. Court of Appeals approving an injunction to block the launch of this medication due to a possible patent infringement.
In the short-term drug prices may go down, but as seen with the wave of generics, this could result in drug prices spiking in the long term. The price of biosimilars could increase as the generic drug prices have increased. Is this really an effective way to control drug costs? Short term it is a great solution! It makes sense… Immediate gain for all! Long term, the old saying “learn from your mistakes” (aka generic pricing all over the place) comes to mind. Will this just be another round of smoke and mirrors of steps taken to help lower drug costs?
Will Manufacturers play the same games to control the cost of biosimilars as they have with generics? Only time will tell although combined with new proposed legislations and a big push for industry transparency, we are hopeful that these positive changes will take place!
Burki, T., (2015). First biosimilar drug approved in the USA. Lancet Oncology, 16 (4), 161. Retrieved from: http://proquest.com
Maas, A. (2015). Biosimilars update: appeal date is set; FDA finalizes guidance. Speciality Pharmacy News, 12 (5). Retrieved from: http://aishealth.com | http://www.dpc.senate.gov/healthreformbill/healthbill70.pdf
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