Celerion and Ricerca Biosciences have formed a biosimilars alliance focused on preclinical and early clinical assessment of biologics manufactured by a new supplier. The Biosimilars Alliance will offer access to all of the services required to perform early assessment of the viability of a potential biosimilar product before initiating multi-center comparator studies in the target patient populations.
 
Services include in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies to support CTAs and INDs. The Biosimilars Alliance also provides access to bioanalytical assay development to enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modeling, immunogenicity screening during clinical studies and the regulatory and integrated project management support. The alliance will also work with other providers to offer comprehensive services for biosimilar development.
 
“The announcement of The Biosimilars Alliance demonstrates Celerion’s ability to respond to client needs and offer effective solutions that leverage the knowledge base built up over the past 20 years of supporting biologic drug development,” said Susan Thornton Ph.D., president and chief executive officer at Celerion. “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.”
 
“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,” said Ian Lennox, chief executive officer of Ricerca. “The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients.”