Neupogen bioequivalent shown to work as well as original

RICHMOND, Va. Insmed has released results from a clinical study which showed that its drug, INS-19, a recombinant human granulocyte colony stimulating drug for the treatment of neutropenia, a disorder characterized by an abnormally low amount of white blood cells, was bioequivalent to Amgen’s Neupogen.

According to the company, this makes Insmed the first U.S. company to successfully demonstrate bioequivalence for a follow-on biologic product.

“These results are very exciting as they represent Insmed’s ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug,” said Dr. Geoffrey Allan, president and chief executive officer of Insmed. “To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is positioned to be a leader in the field. Demonstration of bioequivalence is typically the sole clinical requirement to support FDA approval of generic drugs today. Thus, based on this data, Insmed intends to request a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19.”

Insmed is also working on creating another follow-on biologic; this one is a version of another one of Amgen’s chemotherapy drugs, Neulasta. The company has completed pre-clinical pharmacological and pharmacokinetic studies for the product, INS-20 and intends to start a phase I bioequivalence study of the drugs in the fourth quarter of this year.

Neulasta and Neupogen combined had worldwide sales of almost $4.3 billion in 2007, according to Amgen.