SEATTLE--(BUSINESS WIRE)--BioSim Pharmaceuticals, Inc. today announced that it has selected CPC Scientific to supply BioSim with their cGMP ACTH peptide. BioSim’s ACTH Gelatin Depot 80 IU/mL product is a copy of the branded drug H.P. ACTHAR®, manufactured by Mallinckrodt Plc (NYSE: MNK). CPC Scientific's advanced purification plant enables it to meet all anticipated needs of BioSim in a more timely manner and BioSim will no longer require its previous synthetic supplier for this portion of the ACTH Gel manufacturing supply chain.
BioSim has been advancing its ACTH (Corticotropin) Gel since 2012. With significant research and development, coupled with government support, its product has been demonstrated to perform like ACTHAR in mammal models over the same duration of action. In October of last year, BioSim received a boost to its timelines and is now expected to become the first copy of ACTHAR to reach the market, all while becoming the lowest costing version. Without potentially insurmountable regulatory restrictions like having to demonstrate equivalence to an unavailable expired product or bridging, manufacturing, and safety issues seen in newer formulations requiring extensive human trials, BioSim expects to capture over half the ACTHAR market very quickly and soften demand for any third-party ACTH products.
In the past decade, biosimilars, complex generics, and 505(b2)s for rare diseases have exploded. For established companies like Mylan (NASDAQ: MYL) and Dr. Reddy's Labs (NYSE: RDY), as well as niche players like Amneal and USV Biologics, the US market continues to see rapid growth. BioSim has positioned itself to take advantage of that change, all with the goal of lowering costs of medicine for America’s Healthcare System.
ABOUT CPC SCIENTIFIC
With over 10 years of service to the peptide market, CPC Scientific manufactures quality custom peptides for research and clinical use. CPC Scientific and CPC comprise the CPC Group. The CPC Group is a trusted provider of high-quality, complex peptides for researchers and pharmaceutical companies worldwide. For more information, visit www.cpcscientific.com.
ABOUT BIOSIM PHARMACEUTICALS
BioSim, a Seattle-based pharmaceutical company started in 2012, is focused on building a portfolio around hard to copy generic drugs and biologics for the orphan disease market. For more information, visit www.biosimpharmaceuticals.com.
H.P. ACTHAR®, which treats Infantile Spasms, Multiple Sclerosis, and other indications, is a registered trademark of Mallinckrodt.