The FDA's surprise approval of a generic version of the blood thinner Lovenox is buoying Sandoz's ambitious plans for the emerging biosimilar market. While not a protein therapy typical of biologics, Sandoz chief Jeffrey George tells Forbes that Lovenox's complex sugar structures make it hard to copy. And the agency's willingness to approve a copy will embolden others interested in making competing protein drugs.
"It underscores that the FDA really does have the institutional courage to approve affordable high quality alternatives to some of the more difficult-to-make products that are out there. There were a lot of interests lined up against this approval," George says. And the big payoff may really start taking shape in 2015 and 2016, he adds, as some blockbuster biologics lose patent protection.
Not everyone may see the generic Lovenox story in quite the same light as Sandoz, a subsidiary of Novartis. Under the FDA's new regulatory pathway, developers will have to mount expensive late-stage development programs for biosimilars, restricting the number of potential players to a relatively small group of companies with deep pockets.
- here's the report from Forbes