Biologic drugs are generally derived from a living organism that can come from many sources, including humans, animals, microorganisms, or yeast. Biologics are seven out of the top ten highest selling drugs in the U.S with treatments that can cost $100,000 or more per year for a patient. However, more than $70 billion biologics will be off patent by 2017.
On the other hand, a biosimilar product is a biological product that is approved based on showing that it is highly similar to an already approved biological product known as a reference product. The biosimilar must also show that it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
According to estimates, biosimilars may produce almost $5 billion in sales in Europe in 2015. Although one biosimilar has just been approved, biosimilars are not a major market yet in the U.S. The pharmaceutical industry wants to bring a number of biosimilars to market in the U.S where sales could be even higher.
Sumant Ramachandra M.D, PhD, Senior Vice President and Chief Scientific Officer at Hospira, www.hospira.com as one of the panelists, spoke at the Alliance for Health Reform www.allhealth.org briefing held to discuss the many issues surrounding biosimilar products.
He said “Bringing biosimilars to the U.S is the next major step toward reducing costs for the healthcare system. Since costs are lower for biosimilars, the introduction of biosimilars in the U.S is expected to increase accessibility and provide cost savings.”
To begin the process, FDA www.fda.gov recently approved the first biosimilar product which is the Sandoz www.sandoz.com drug called Zarxio a biosimilar to Amgen’s Neupogen (filgrastim) which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen.
To discuss the FDA approval process for biosimilars, Sally Howard J.D, Deputy Commissioner for Policy, Planning, and Legislation at FDA reported on how FDA begins the process by reviewing structural and functional characterizations, examining animal studies, human pharmacokinetic, pharmacodynamics, and clinical immunogenicity data, along with other clinical safety and effectiveness data.
Geoffrey Eich, Executive Director of External Affairs at Amgen www.amgen.com said, “It is essential to develop appropriate regulatory standards for biosimilars to enable patient safety, high quality, and reliable supplies to be available. Also, having sound scientific standards will enable biosimilars to successfully withstand scrutiny and will build trust among providers.”
In addition, FDA must also address interchangeable biological products. An interchangeable biological product in addition to meeting the biosimilar standard must produce the same clinical result as the reference product in any given patient. Manda Bartelme, Director of Reimbursement at Avalere Health http://avalere.com said that FDA will need to address interchangeability and how interchangeability will be determined.