Celerion and Ricerca Biosciences to provide integrated service for biosimilars
Will test viability of a potential biosimilar early in the process
Celerion and Ricerca Biosciences have agreed to provide an integrated service for companies developing and commercialising biosimilars.
The collaboration, called the Biosimilars Alliance, will focus on preclinical and early clinical assessment of biologics manufactured by a new supplier. It will offer access to all of the specialised services required to perform early assessment of a potential biosimilar product before beginning costly multi-centre comparative studies in the target patient populations.
Services offered under the new partnership include in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies to support CTAs and INDs.
The alliance also offers access to bioanalytical assay development to enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modelling, immunogenicity screening during clinical studies and the regulatory and integrated project management support to ensure timely results for strategic decision-making.
Susan Thornton, president and chief executive of Celerion, said the formation of the Biosimilars Alliance ‘is consistent with Celerion’s goal of providing fully integrated services to get to go/no go decisions quickly’.
Ian Lennox, chief executive of Ricerca, added: ‘Ricerca Biosciences is well positioned in Europe, Asia and North America to enhance the success of the Biosimilars Alliance.
‘Biosimilars are a rapidly growing segment of the market and we see increasing demand from our clients for safety and efficacy testing to assess viability.