Innovator pharma and generic giants have generated headlines as they scramble to bring follow-on biologics to market. However, Charles River Laboratories’ (CRL) client mix includes a third, less publicised group of companies – small biobetter-focused biotechs.
Christina Satterwhite, associate director of laboratory science at CRL’s site in Reno, Nevada, told Outsourcing-Pharma, innovator pharma, generic manufacturers and biobetter-focused biotechs are all seeking services.
Biobetter-focused biotechs have been set up to improve a biologic due to come off-patent, for instance by lowering immunogenicity, before licensing the compound to a larger company. In August 2010 the Wall Street Journal profiled three biotechs pursuing similar biobetter strategies.
Being small, and in some cases virtual, the biotechs developing biobetters are reliant on service providers such as CRL. Using experience gained serving innovator biotechs CRL supports assay development, preclinical toxicology, pharmacokinetics and other biobetter development work.
Demand for services linked to biosimilars and biobetters from all types of clients, pharma, generic and biotechs, has increased significantly over the past two years, said Satterwhite. In this time biologics edged closer to patent expiration and the US developed a biosimilar approval pathway.
A clear pathway
Much about biosimilars is still unclear though. Last week the US Food and Drug Administration (FDA) acknowledged this when it proposed that review fees for biosimilars should be comparable to innovator biologics, at least initially.
“Review to determine biosimilarity or interchangeability of a proposed product in a [biosimilar] application is expected to becomparably complex, technically demanding, and resource-intensive as review of a proposed [innovator biologic] application”, said the FDA.
Biobetters lack an abbreviated pathway. Instead developers follow the same route as innovator biologics. This avoids the uncertainty of showing biosimilarity and, by retracing the steps of an approved and successful product, is expected to have a lower failure rate than innovator drugs.