The Biosimilars Alliance will offer access to all of the specialized services required to perform early assessment of the viability of a potential biosimilar product before beginning costly multicenter comparator studies in the target patient populations. These services include in-vitro and in-vivo pharmacological assessments of activity and toxicological and immunotoxicological studies to support CTAs and INDs. The 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 to ensure timely results for strategic decision-making.

 

“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,” says Dr. Susan Thornton, president and CEO of 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,” says Lennox. “The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients.”  

 

Farmen emphasizes that the alliance is based on the long-term working relationship between the two companies, and there are no contracts between the two, nor any exclusivity.

 

“We trust each other,” he says.

 

Celerion provides early-stage clinical research solutions from facilities strategically located around the world, with more than 730 beds in Phases I and IIa, NDA-enabling clinical pharmacology, ADME, clinical pharmacology sciences, global bioanalytical services (discovery through late-stage) and drug development services. Sister company Ricerca Biosciences offers a suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in-vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. It operates out of U.S.-based facilities in Concord, Ohio, and Bothell, Wash., and ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon and Concord facilities hold AAALAC certification.