Biological Generics: A Business Case

Biological generics are protein products comparable in quality, safety, and efficacy to the brand product and marketed after exclusivity has expired. In the US, sales of biologics are expected to exceed US$60bn by 2010 while in the EU the market size for ‘biosimilars’ is estimated to be US$16–20bn per year by 2010–2011. Biological drugs for which the patent period has expired or is soon to expire include insulin, human growth hormone, interferons, erythropoetin, growth factors, monoclonal antibodies, and blood factors. Not all biological products are currently candidates for various technical and scientific reasons; however, most are. The economics of biological generics will be different than chemical generics. While savings equivalent to a chemical generic may not be realised by the end user, savings in terms of absolute dollars will be substantial. In the EU, so far two ‘biosimilars’ have been approved, while in the US the FDA is reviewing and approving Follow-on Protein Products under the FD&C Act, £505(b)(2). As with chemical generics, challenges and opportunities exist. The entry of biological generics will result in rewards for all. As these products range in the complexity of their molecular structure and indications, the mantra of biologics — case-by-case drug development — will need to be followed.