Merck Fine-Tunes Biosimilars Strategy as FDA Guidelines Loom

Xconomy New York — 

The pharmaceutical world is abuzz over rumors that the FDA is on the verge of releasing its guidelines for how companies should develop generic versions of biotech drugs. Among the folks waiting eagerly for those guidelines is Michael Kamarck, president of Merck BioVentures, who was literally sitting on the edge of his seat when he met with Xconomy at a Times Square hotel recently to talk about the drug giant’s strategy for making such drugs, known in the industry as biosimilars. “We don’t know exactly what the guidelines will say,” Kamarck says. “But we are confident we have a path to move forward and we can succeed.”

Merck (NYSE: MRK) formed its BioVentures unit in 2008 with the goal of developing a portfolio of generic biotech drugs. Kamarck, a veteran of Wyeth, joined Whitehouse Station, NJ-based Merck in December 2009, just after Pfizer (NYSE: MRK) acquired Wyeth. “I had been with Merck two months, when the Biologics Cost Competition and Innovation Act was approved as part of the Obama health care program,” Kamarck recalls. “That was the FDA signaling a pathway for us to bring biosimilars through to licensure.”

Because biotech drugs are large, complex molecules, few people expect biosimilars to be exact copies of the originals. But as their name implies, they will have to be similar enough to be as safe and effective as the drugs on which they are based. That means Merck and other companies developing biosimilars will have to jump through many more hoops than makers of “small-molecule,” chemical-based generic drugs do. “All they have to do is the chemical analysis to show it’s the same drug,” Kamarck says. “We will have to do some amount of clinical study to prove safety and efficacy.”

As they waited for the FDA to release its official guidelines for performing such studies, Kamarck and his team embarked on a multifaceted plan designed to strengthen Merck’s readiness to enter the new market for biosimilars. The company’s goal was to have five or more biosimilars in the pipeline, with some ready to launch in 2016, when patents on the originals are set to expire. “To hit that business target, we looked at areas where we had gaps, and we went out to close them,” he says.

Four deals make up the crux of Kamarck’s plan. The first, which happened 10 months before he joined the company, was Merck’s $130 million purchase of Insmed’s biologics platform. As part of the deal, Merck acquired rights to INS-19 and INS-20—generic forms of filgrastim (Neupogen) and pegfilgrastim (Neulasta), hit drugs from Amgen (NASDAQ: AMGN) that are used to prevent infections in patients undergoing chemotherapy.

Then, in January of this year, Merck formed an alliance with Waltham, MA-based Paraxel International (NASDAQ: PRXL), a contract research organization. “They will be the exclusive arms and legs for us in doing the clinical studies that are required” to get biosimilars approved, Kamarck says.

Deal number three was a bit of a personal mission for Kamarck. During his decade at Wyeth, Kamarck worked closely with etanercept (Enbrel), the $7-billion-a-year drug that Amgen and Wyeth (now Pfizer) market together to treat inflammatory diseases such as rheumatoid arthritis. “We scanned everyone who was … Next Page »

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