bioRASI has issued comments to the FDA in connection with the recent Draft Guidelines Relating to the Development of Biosimilar Products. “bioRASI is pleased that the FDA is making strides towards establishing a domestic approval pathway for these important drugs, which will provide patients with increased access to life saving medications,” said Boris Reznik Ph.D., chairman of bioRASI. “Just as the Hatch-Waxman Act facilitated the approval and marketing of lower cost but equally safe and effective small molecule drugs, the pending regulations and accompanying legislation will allow for the delivery of follow-on biologics to a greater population in the U.S. and abroad.”
“Many of our current clients are planning their expansion from generic drugs into the biosimilars market,” added Dr. Reznik. “As a powerful leader in generic drug development, bioRASI is leveraging our 10 years of biologics experience to advance these clients on their path to success.”
bioRASI has also commented on the three FDA issued guidance documents that were released in February 2012. The company participated in the public hearing regarding these documents on May 11th, and together with biopharmaceutical opinion-leaders, provided input on the draft guidelines. bioRASI’s comments related primarily to facilitating the approval pathway for biosimilars in various conditions of use, and for the demonstration of interchangeability as a path that can potentially be beneficial both for patients and for the biosimilars industry as a whole.