Sister companies trod biosimilar path

LINCOLN, Neb.—Celerion, a provider of early-stage drugdevelopment solutions, and Ricerca Biosciences, a drug-safety assessmentspecialist, have formed the Biosimilars Alliance, which will focus onpreclinical and early clinical assessment of biologics manufactured by a newsupplier.

The two new partners have long operated as "sistercompanies," says Celerion's vice president of global bioanalytical services,Dr. Raymond Farmen, with Ricerca's CEO Ian Lennox also serving as chairman ofthe board at Celerion. The formation of the new alliance was driven by "clientdemand for an integrated service solution for the development of biosimilarproducts," the companies claim, but also quite probably by the existing levelof uncertainty about regulatory issues. The goal will be to bridge the gapbetween newly sourced products and patient studies.

The market for biosimilars is forecast to grow from $2.4billion in 2012 to $44 billion by 2020. While there has been an establishedpathway for the approval of biosimilar products in Europe for several years,the U.S. Food and Drug Administration has only recently issued its guidances.And the process is not likely to be as simple as some may envision.

For example, Farmen cites a study where no GMP analyticaldifferences could be found between batches but PK studies in mice revealedcompletely different efficacy profiles, with two batches failing completelywhile two others presented good concentration curves. Also, Farmen notes theimportance of determining if the assay is for free drug or total drug when youare developing the bioanalytical assay.

"You need to develop a strategy upfront for developingassays," he says, because large molecule biosimilars are likely to result inmore variability.

The Biosimilars Alliance will offer access to all of thespecialized services required to perform early assessment of the viability of apotential biosimilar product before beginning costly multicenter comparatorstudies in the target patient populations. These services include in-vitro and in-vivo pharmacological assessments of activity and toxicological andimmunotoxicological studies to support CTAs and INDs. The alliance alsoprovides access to bioanalytical assay development to enable pharmacokinetic(PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PDmodeling, immunogenicity screening during clinical studies and the regulatoryand integrated project management support to ensure timely results forstrategic decision-making.

"The announcement of the Biosimilars Alliance demonstratesCelerion's ability to respond to client needs and offer effective solutionsthat leverage the knowledge base built up over the past 20 years of supportingbiologic drug development," says Dr. Susan Thornton, president and CEO ofCelerion. "The formation of the Biosimilars Alliance is consistent withCelerion's goal of providing fully integrated services to get to go/no-godecisions quickly."

"Ricerca Biosciences is well-positioned in Europe, Asia andNorth America to enhance the success of the Biosimilars Alliance. Biosimilarsare a rapidly growing segment of the market, and we see increasing demand fromour clients for safety and efficacy testing to assess viability," says Lennox."The Biosimilars Alliance is an important step for Ricerca in supporting thefuture needs of our clients."

Farmen emphasizes that the alliance is based on thelong-term working relationship between the two companies, and there are nocontracts between the two, nor any exclusivity.

"We trust each other," he says.

Celerion provides early-stage clinical research solutionsfrom facilities strategically located around the world, with more than 730 bedsin Phases I and IIa, NDA-enabling clinical pharmacology, ADME, clinicalpharmacology sciences, global bioanalytical services (discovery throughlate-stage) and drug development services. Sister company Ricerca Biosciencesoffers a suite of discovery, preclinical and development services to supportdrug 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 ofclinical and commercial API. It operates out of U.S.-based facilities inConcord, Ohio, and Bothell, Wash., and ISO 9001-certified facilities in Taipei,Taiwan, and Lyon, France. The Lyon and Concord facilities hold AAALACcertification.