A routine vote by an advisory panel to the U.S. Food and Drug Administration this week on a cancer drug made by Novartis could have major consequences for Boston-area biotech firms.
On Wednesday, the FDA’s panel charged with reviewing new cancer drugs voted unanimously to recommend approval Novartis’ EP2006, a biologic drug designed as a generic version of Amgen’s Neupogen, which boosts white blood cell count in cancer patients. If the FDA follows the recommendation of the committee – and it usually does – the drug would be the first so-called biosimilar, a generic of a type of drug becoming more and more common, which is created by biologic, rather than chemical, means.
But does this vote open the floodgates to allowing this new kind of generic drug in the U.S.? Maria Laccotripe Zacharakis, a partner at McCarter & English who has been following the FDA’s progress in biosimilars, says no. She says there’s still a high bar for companies to prove “biosimilarity” to an existing drug, and special circumstances surrounding EP2006 (such as the fact that it’s been on the market for years in Europe already) won’t necessarily apply to other drugs.
“Certainly this is good news for biosimilars,” she said. “But it doesn’t mean every other product will be approved as easily.”
Click to read the full article: “FDA Panel Recommends Approval of a New Kind of Generic Drug in the U.S.”