Biosimilars are subsequent versions of innovator biopharmaceutical products manufactured and proved to be simialr to that of innovator product. The biosimilars are marketed after the patent and exclusivity expires on the innovator product.
The second generation of biopharmaceuticals manufactured using recombinant technologies were launched in late 1990s/early 2000s, and patents protecting them are now nearing expiration. Recombinant proteins currently command premium pricing due, in part, to the high manufacturing costs associated with their production, superior safety and efficacy profiles, and limited or absent competition. It has been estimated that by the end 2020, many blockbustor biopharmaceuticals will have lost patent protection and this has laid the foundation for the development, manufacturing and marketing of biosimilars. A recent study (IMS health) has reported that the global biosimilar market in 2015 is expected to 2500 Million USD with a CAGR of 52% during 2010 - 2015. In US alone the biosimialr market is expected to grow to 11.4 Billion USD by 2020 (source (IMARC).
At Apcegen we have identified biosimilar development and manufacturing as the one of the thrust areas. Currently, the team is working on three biosimilar drugs that are at various stage of development.