First — do go read the whole Xconomy | New York story. It lines out, in nice detail, the four recent Merck deals that set the course for its biolsimilars efforts. All that is missing now, is the guidance map from FDA. And that piece is expected — literally, at any moment.
Here is a bit of the fine Xconomy | New York article — as a teaser, on prong three of the strategy. Whitehouse Station is taking aim — with Seoul’s Hanwha — at a biosimilar version of Pfizer’s $7 billion a year arthritis blockbuster, Enbrel®:
. . . .During his decade at Wyeth, Kamarck [now leading biosimilar efforts at New Merck] 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 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. . . .”
Do stay tuned — the word could come from FDA at any time, now. These are exciting times, indeed.
The FDA guidance will open new doors to additional, system-wide savings, from the March 2010 US health care reform package called the Affordable Care Act, as non-exclusive, competing versions of large, complex bio-molecules eventually make their way onto the US marketplace.