A quick hitter from Outsourcing-pharma.com. CROs like Charles Rivers report a noticeable increase in development services are being requested by innovator pharma, generics and biobetter small biotechs as they attempt to introduce follow on biologics.
Many of the biobetter companies are small -- and many times virtual -- and rely on an outsourcing development model. They're buying services like assay development, preclinical toxicology, pharmacokinetics and other biobetter development work. The surge in demand has really upticked in the past two years.
Biobetters do not try to mimic existing biologics and won't use the as yet unspecified FDA pathway for biosimilar approval, but must follow the same path as innovator drugs. However, as biobetters are targeting proven drug targets with "enhanced properties" of some sort, their failure rate (and therefore risk) is considered to be lower. Though one might argue the technical risk is lower but the commercial risk is high unless the enhancement is differentiating and important to imporved patient care. Nevertheless, it appears that many smaller firms are going to test this route and will need help to do so.
Posted by Bruce Lehr May 16th 2011.