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Sister companies trod biosimilar path
LINCOLN, Neb.—Celerion, a provider of early-stage drug development solutions, and Ricerca Biosciences, a drug-safety assessment specialist, have formed the Biosimilars Alliance, which will focus on preclinical and early clinical assessment of biologics manufactured by a new supplier.
The two new partners have long operated as "sister companies," says Celerion's vice president of global bioanalytical services, Dr. Raymond Farmen, with Ricerca's CEO Ian Lennox also serving as chairman of the board at Celerion. The formation of the new alliance was driven by "client demand for an integrated service solution for the development of biosimilar products," the companies claim, but also quite probably by the existing level of uncertainty about regulatory issues. The goal will be to bridge the gap between newly sourced products and patient studies.
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 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 analytical differences could be found between batches but PK studies in mice revealed completely different efficacy profiles, with two batches failing completely while two others presented good concentration curves. Also, Farmen notes the importance of determining if the assay is for free drug or total drug when you are developing the bioanalytical assay.
"You need to develop a strategy upfront for developing assays," he says, because large molecule biosimilars are likely to result in more variability.
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.