Merck Fine-Tunes Biosimilars Strategy as FDA Guidelines Loom

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working on [biosimilar etanercept] to try to find the best one,” Kamarck says. “We felt to have one of the big ones would help us learn about this new business. We viewed it very much as a linchpin.” But the drug—a molecule known as a “fusion protein”—is complex and not easily duplicated.

Merck found the best biosimilar etanercept, Kamarck says, in an unexpected place—Seoul, Korea. In June, Merck formed a deal with Hanwha Chemical to develop and commercialize its version of the drug, HD203. “They manufactured it, they put it in Phase 1 trials, they shared the data with us,” Kamarck says. “It’s a fantastic copy.”

Michael Kamarck is the president of Merck BioVentures

Kamarck’s team sewed up the fourth element of Merck’s biosimilars strategy on September 21, when it formed a 15-year manufacturing capacity-sharing agreement with Gaithersburg, MD-based MedImmune. “We did a forecast of this business, and suffice it to say, it was clear we needed additional manufacturing capacity,” Kamarck says. “The decision was, did we want to invest $700 million and five years to build a new facility, or did we want to find an enthusiastic partner that already had one populated with expertise? It’s not a tough decision.” The factory, located in Frederick, MD, is already making biosimilars for Merck’s clinical trials, Kamarck says.

Rumors that the FDA would soon release its biosimilars guidelines reached fever pitch on September 23, when Reuters published a story quoting an agency official saying they would be published “as early as the next few weeks, maybe even days.” Kamarck expects the requirements will differ for each molecule, depending on its complexity, but that overall the FDA will allow for the process to be a shortened version of what it requires for entirely new drugs. The FDA hinted at that in a paper it published in the New England Journal of Medicine in August. Says Kamarck of the impending definition of the approval pathway, “Until we try it and are disappointed, we’re going to assume the best.”

One major way biosimilar drugs will differ from standard generics will show in Merck’s marketing plan, Kamarck says. Even though the drugs will be similar to the originals, they will be new products, and therefore marketed like any other branded drug. “They’ll say ‘Merck’ on them,” Kamarck says. “And because of that, we’re going to do our best to make sure that payers, patients, and physicians get everything they need.” That may include setting up a call center for patients to use if they have questions about self-injecting the drugs, or performing cost-benefit studies for payers making decisions about whether or not to cover biosimilars.

All that plus the clinical trials will be expensive, Kamarck acknowledges, but well worth it, in Merck’s view. “We have an opportunity to make the products less expensive, and still capture a decent profit margin,” he says.

Kamarck declines to elaborate on what else is in Merck’s biosimilars portfolio aside from its copies of the three Amgen drugs. But he does say the company has five biosimilars in human trials and is working on many more. And he believes his unit will ultimately help further the company’s overall goal of making cutting-edge medicines affordable enough to be used not only here in the U.S.—where cost-cutting in healthcare is a hot topic—but also in emerging countries. “The challenge of these molecules, frankly, is they’re so efficacious they’re putting a lot of pressure on healthcare dollars,” he says. “Merck’s focus is broadening now, from just being a company focused on innovation to also providing patient access by lowering costs.”

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