FDA: New Regulations for Biosimilar Drugs

Source: bioprospecting from May 20, 2014, the US Food and Drug Administration (FDA) released the regulatory path of Biomimetic Drugs through three documents, and published specific publications in the US as the draft requirements for FDA to guide clinical pharmacology The U.S says its biosimilars policy has lagged behind the rest of the world, including Europe and Canada, in its efforts to develop a regulatory approach based Biopharmaceutics that are no longer protected by patents Since March 2010, biosimilars in the United States are on the way to the market Regulatory requirements are too vague to encourage developers to take risks and costs to develop these drugs for the United States market Now, FDA has detailed how to deploy clinical pharmacology data of biosimilars, including pharmacokinetic (PK) and pharmacodynamic demand (PD) data The draft includes research design and population, dose selection and statistical comparison, as well as a 90 day review of the opening-up, with the aim of formulating the gold standard for the development of high-priced brand bio generic drugs Even a manufacturer's product can show differential production runs, such as patterns of side chain protein drugs However, due to the biological complexity, it means that in the development process of generic drugs, it is almost impossible to have drugs that completely duplicate small molecule drugs According to the FDA definition, there is no clinically significant difference between a biological imitation product and the "safety, purity and efficacy" of a reference drug, but slight differences are allowed in clinical pharmaceutical vitality The document also states that "clinical pharmacology research is a step-by-step process of demonstrating the properties of biopharmaceuticals Demonstrate an effective biosimilars product by demonstrating no clinically significant differences " Europe has the longest history of allowing Biomimetic Drugs to enter the market More than ten protein Biomimetic Drugs and two monoclonal antibodies have been approved for sale Frost & Sullivan Frost & Sullivan (hereinafter referred to as "Sullivan") recently predicted that the bio generic pharmaceutical industry has entered a golden period of rapid growth, and the generic pharmaceutical market will grow exponentially from $1.2 billion last year to $23 billion in 2019.