[Editor’s note: This story has been expanded to provide additional details and corrected to note that the office of Max Neeman in Cary is not new.]

CARY, N.C. – Max Neeman, a contract research organization based in India, which has an office in Cary, is expanding its services to focus on testing of “biosimilars.”

The science service firm’s N.C. office is the only one outside its home country.

Max Neeman plans to add testing biosimilars, which are copies of drugs that are based on recombinants or re-engineering of DNA. Among such products are insulin, human growth hormone and interferon.

Biosimilars can be made once patents on recombinant drugs have expired.

“Biosimilars or Follow-on biologics are terms officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product,” explained Donald Swankie, who heads the Cary office as well as business development for the company.

“Biosimilars exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. Hence, the follow-on manufacturer does not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance therefore clinical trials are very important for Biosimilar products.

“The size of the required clinical program will depend on the level of understanding about the protein structure, the impurity profile, and other characteristics, as well as the ability to demonstrate therapeutic equivalence,” he added.

The 10-year-old company says it can offer biosimilar testing services to drug companies and other clients in India at a “relative cost advantage” and “lower regulatory requirements for establishing bioequivalence which also helps to keep development costs low.”

Swankie noted that the company is not shifting its focus to Biosimilars.

“We would not claim to ‘focus’ as priority on Biosimiliars only that, having run recent and significant trials and seeing the potential growth, have added such services and focus to an already robust practice with trials in oncology, cardio, metabolics, device, etc.,” he wrote in an e-mail.

“We are also part of the Hospital Max Healthcare organization and as such leverage expertise from this part of our organization as well,” Swankie added.

Max Neeman has some eight employees in the U.S. and does have a number of RTP clients, according to Swankie.

The Triangle is home to several international CROs and life science service firms, including the largest, Quintiles. 

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