Samsung Bioepis offers a glimpse at biosimilar manufacturing prowess

A brief presentation by Samsung Bioepis at Singapore's BioPharma Asia meeting this past week offered a solid glimpse into how the joint venture with Biogen ($BIIB) was able to move in four years from idea to approval and the culture involved.

Brian Hosung Min

Brian Hosung Min, vice president of the Process Team at the Incheon-based company, spoke with FiercePharmaAsia on the sidelines of the conference and suggested that meticulous planning and "hard work" were the two main ingredients that brought the venture Europe's first approval for a biosimilar of Amgen ($AMGN) and Pfizer's ($PFE) blockbuster Enbrel (etanercept).

"I was part of the planning stage and initially there was no right answer on how to bring a biosimilar from idea to approval, there were no guidelines," Min said. "Of course we talked to industry people and consultants. But from our perspective this was a blockbuster drug and we just thought it was a good business to get into."

Min noted that South Korea has a rich biopharma ecosystem that produces talent in biology and biochemistry; that solved one of the first hurdles--mapping out the hiring.

But a key strategic move in the process end of development, Min said, was the decision to scour the globe for a large supply of originator product well before development started that yielded 127 different lots of Enbrel from sources in Europe, the U.S. and the rest of the world (RoW).

This allowed the company to run 57 chemical assays and 27 biofunctional analysis in parallel, greatly speeding up the ability to set a comparator benchmark into what would become Benepali, he said. That pace of effort at a company of now 500 people that started in 2012 begs the question of the work culture.

But Min said that the idea of a startup feel was not part of the drive.

Samsung Bioepis CEO Christopher Ko

"The hires were young and enthusiastic, I think the average age is 32 years old, so it's a young company," he said. "But the guidance was we need to work hard. We were fast. We knew there was competition so time was of the essence. Ultimately, we made good decisions and took some risks."

He did give a shout-out to Samsung Bioepis CEO Christopher Ko as "enthusiastic" on the partnerships with Biogen as well as Merck ($MRK) on sales that helped the company go from local to global.

A Singapore-based consultant who attended Min's slide presentation was one of the original team members on Enbrel for Pfizer. She noted that the aim to get the process right through wide sourcing of originator products and related testing was "inspired."

"They did exactly the right thing, which is pretty amazing," she said after the presentation. "They zeroed in on the process. An originator has many more things going on."

Data graphically displayed at the conference presentation, but not made available, showed key parameters of similarity between original and the biosimilar in sync and in some cases--such as injection site reactions--at a finer clip than the original.

This attention to detail sets the company up as it moves to a widely expected initial public offering, possibly this year, and completes work on five other candidates, all well referenced to originals as with Enbrel, for biosimilars of Remicade, Lantus, Humira, Herceptin and Avastin--with another 7 molecules at early stages, Min noted, adding "this is one of the deepest."

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