Lincoln, Neb.-based Celerion, a provider of early-stage drug development solutions, and Ricerca Biosciences, which offer discovery, preclinical and development services, have formed “The Biosimilars Alliance,” focused on preclinical and early clinical assessment of biologics manufactured by a new supplier.
The formation of The Biosimilars Alliance was driven by client demand for an integrated service solution for the development of biosimilar products. The market for biosimilars is forecast to grow from $2.4 billion in 2012 to $44 billion by 2020. While there has been an established pathway for the approval of biosimilar products inEuropefor several years, the FDA has only recently issued its guidances. The foundation now exists for development of newly sourced versions of some of the most effective treatments that have emerged from medical research in the last 20 years.
The Biosimilars Alliance offers all of the specialized services required to perform early assessment of the viability of a potential biosimilar product, before beginning costly multi-center 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 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 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,” said Susan Thornton, Ph.D., 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,” said Ian Lennox, CEO of Ricerca. “The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients.”
The Biosimilars Alliance will also work with other solution providers to offer the full scope of services required to bring biosimilar products to market.