Insmed: Biosimilar Matches Amgen Drug Neupogen
Insmed Inc. (NASDAQ CM: INSM), a Richmond-based developer of follow-on biologics and biopharmaceuticals for unmet medical needs, announced that it has demonstrated the bioequivalence of INS-19, the company’s recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen®, an FDA-approved G-CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion.
Human bioequivalence studies utilize well-established, FDA-recognized methodology with rigorous standards. Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen®. G-CSF concentration profiles for the two products were identical. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen®. These human INS-19 and Neupogen® data complement Insmed’s extensive analytical testing and comparative data from pre-clinical assessments.
“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 CEO 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 has one of the most robust follow-on biologics pipelines in the industry. Building upon the success of INS-19, the company has also completed pre- clinical pharmacological and pharmacokinetic studies for its second follow-on biologic product, INS-20, which has demonstrated comparability to FDA-approved Neulasta®. Based on these data, Insmed intends to initiate a Phase I bioequivalence study of INS-20 in humans in the fourth quarter of 2008. Insmed intends to seek approval of both products in the U.S. and launch the products on expiration of the relevant innovator patents.
