Celerion and Ricerca Biociences have established a Biosimilars Alliance through which they can offer clients a full scope of integrated, specialist services for developing and commercializing biosimilars. Services will include in vitro and in vivo pharmacological assessments to support regulatory clearance of clinical trials, access to bioanalytical assay development expertise for pharmacokinetic and pharmacodynamic evaluation, PK/PD modeling, and immunogenicity screening during clinical studies. Clients will also have regulatory and project management support.
Celerion and Ricerca say estimates suggest that the market for biosimilars will grow from $2.4 billion in 2012, to $44 billion by 2010. “Biosimilars are a rapidy growing segment of the market and we see increasing demand from our clients for safety and efficacy testing to assess viability,” remarks Ian Lennox, Ricerca CEO.
Ricerca offers a range of discovery, preclinical, and development services to support the development of drug candidates from lead identification through IND and NDA. Capabilities include molecular through in vivo screening and profiling, radiochemistry, IND-enabling toxicology, API process chemistry, and cGMP manufacturing of clinical and commercial API. The firm’s U.S. facilities are in Ohio, Washington, and it also operates ISO 9001-certified facilities in Taipei (Taiwan), and Lyon (France).
Celerion’s capabilities span services for early drug development and clinical pharmacology. The firm offers clinical research (through to NDA-enabling studies) expertise, clinical pharmacology services, bioanalytical services (from discovery to late-stage testing of small, large, metabolite and biomarkers), and drug development services including project management, regulatory expertise, and drug development consultancy. Celerion operates out of four U.S.-based facilities.