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 effect...