Compliance Resources to Help you Stay Current

GSK’s new medicine for treating Lupus – Benlysta (generically known as ‘Belimubab’) was rejected by the UK National Health Service’s (NHS) drug rationing body. The drug was discovered by Human Genome Sciences and developed by Glaxo SmithKline (GSK) to combat the disease that causes the immune system to attack joints and organs. This article details why the drug was rejected and outlines the NHS drug approval process.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.