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.
Generic Acthar Could Punish Mallinckrodt
Mallinckrodt was one of several drug companies that previously engaged in a pharma roll-up strategy. High drug prices have since come under scrutiny, hurting Mallinckrodt’s sales and creating questions about the value of its prior deals. Top-selling Acthar had been the company’s saving grace. Its revenue had been growing at double-digits, providing an anchor for the stock.