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US demand for biosimilarity testing growing says specialist CRO

By Gareth Macdonald , 30-Sep-2013

Humira a focus for testing services demand
Humira a focus for testing services demand

Interest in the US biosimilars market is still growing despite Big Pharma delaying tactics and continuing regulatory uncertainty according testing services CRO, BioOutsource.

The Glasgow, Scotland-based contractor made the comment after revealing that while demand for biosimilarity testing services in Europe and Asia is growing, US biosimilar developers have been the firm's key growth driver over the last few months.

CEO Gerry MacKay told Outsourcing-pHarma.com that: “We have seen a huge surge from the US over the last 6 months and this market appears to be growing stronger than elsewhere" adding that “We are working closely with Regulatory consultants in this area and they are also seeing this high demand from US clients probably due to their earlier EU experience.”

BioOutsource’s core business is the provision of testing services that support drugmakers’ efforts to prove that their products are comparable to innovator drugs, which is an area of the services sector that is still relatively underserved according to MacKay.

The niche position we have is to focus on the biological characterisation and to provide an end to end service offering,” he said, adding that “There are some smaller CROs working in this space that offer some of the methodologies, but certainly not across all the technologies we offer nor across the range of biosimilar molecules that we have.”

Abbott’s autoimmune disease monoclonal antibody (mAb) Humira (adalimumab) has been focus for many of the firms with which BioOutsource has worked, with antibody dependent cell mediated toxicity (ADCC) testing being a particularly strong area of demand.

We have tested over 10 different biosimilar Humira molecules along with many different innovator Humira batches,” he explained, adding that “it is not difficult to believe that we have actually more experience looking at Humira in this assays than anyone else.”

BioOutsource plans to further R&D focused investments according to MacKay, who highlighted cell line development as a particular area of interest for the contract research organisation (CRO) going forward.

We have multiple assays using internal engineered cell lines that are used in assays [and are] looking to agree commercial licenses for a further three and have about six more in various stages of development internally.” 

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