UK - Samsung eyes generic biological medicines

Samsung, the South Korean conglomerate, plans to launch generic versions of biological medicines by 2015 at half the current western prices, as it gears up to challenge US and European pharmaceutical companies.

Tae-Han Kim, president of Samsung BioLogics, said his company aimed to complete a manufacturing plant outside Seoul by June, and win international regulatory approval for the factory by the end of this year.

That would pave the way to the launch of a series of lower-cost versions of monoclonal antibodies (MABs) to treat diseases including cancer and rheumatoid arthritis as they come off patent in the next few years.

In an interview with the Financial Times, Mr Kim said: “Biopharmaceutical companies are good for sales, and biotech companies for innovation, but neither is good for manufacturing. It is in Samsung’s DNA to produce products at low prices while meeting legal and industry requirements.

“The price of monoclonal antibodies is very expensive and not affordable to all patients,” he said. “That is a heavy burden on governments and [healthcare] payers.”

While a number of large existing generic drug companies are preparing to offer cheaper versions of “large molecule” or biological drugs, the move by Samsung would represent the entry of a significant new competitor from Asia.

It comes at a time when European regulators have already begun accepting applications from generic companies for post-patent biological medicines – which are far more complex than “small” chemical based molecules – and the US has recently issued guidelines to take a similar approach.

Mr Kim said Samsung, with international expertise in engineering, construction, shipping and electronics, had taken a decision a decade ago to move into medicines, and by 2007 had already resolved to focus on MABs. He said the company had since hired more than two-thirds of its senior executives in the new division from western drug companies.

Samsung BioLogics has already formed a partnership with Biogen Idec of the US, in which it holds the 85 per cent majority stake, for the launch of a series of generic versions of MABs, and has committed more than $2bn in investments in its new plant up to 2020.

But he said the company was also seeking other partnerships, and planned to start developing its own innovative medicines in the coming years.

He said Samsung’s “parallel processing” allowed it to reduce costs and accelerate the speed of developing new manufacturing plants for medicines while boosting the yield, although to win regulatory

“good manufacturing practice” approval within six months of completing a plant would be far quicker than the norm of two or more years.

Andrew Jack

The Financial Times

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