Celerion and Ricera Biosciences have launched a new joint venture to provide a cost-cutting one-stop-shop solution for companies developing and commercialising biosimilars.
The new collaboration, named the Biosimilars Alliance, will focus on preclinical and early phase assessment of the products, which are different versions of a biologic manufactured by a new supplier.
The firms say their new ability to test the viability of a potential biosimilar early on will help reduce the number of studies which come up against a wall in costly multi-centre patient studies.
Services offered under the new partnership includes in vitro and in vivo studies, as well as regulatory support with tox studies for clinical trials and investigational new drugs (IND) – providing the compound’s existing safety data to begin trials more quickly.
The alliance also offers bioanalytical assay development for both animal and human pharmacokinetic (PK) and pharmacodynamic (PD) studies, and immunogenicity screening during trials.
Susan Thornton president and CEO 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.”
Ready for the boom
In a joint statement, Celerion and Ricerca said the move was a bid to meet growing client demand for a one-stop-shop solution for the development of biosimilars.
“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.
However a spokesperson for Biosimilars Alliance said although the market is rapidly growing – with an expected increased from $2.4bn (€1.8bn) in 2012 to $44bn by 2020 – regulators are still lagging behind.
The spokesperson said recent developments mean that firms often require assistance with the new guidelines, adding that the new alliance is well placed to provide this.
“While there has been an established pathway for the approval of biosimilar products in Europe for several years, the US FDA (Food and Drug Administration) has only recently issued its guidances,” the statement read.
“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.”
Lenox added the new partnership will leverage the firms’ established operations within Europe, Asia and North America.
Both firms expanded rapidly in 2010, when they made acquisitions from the divided MDS Pharma including clinical research facilities and bioanalytical laboratories across Europe and the US.