Listen closely, and you'll hear the gnashing of teeth at J&J headquarters. Sandoz has won the European race to develop a generic form of the anemia treatment epoetin alfa - also known as EPO. It's a $7 billion market now dominated by Johnson & Johnson and the California biotech Amgen.
The Novartis unit got E.U. approval for a biosimilar version of J&J's Eprex. The approval covers anemia in patients undergoing chemotherapy and in patients with renal anemia. The individual approval is big news for all the companies involved, true. But it's a sea change in the realm of biologics, treatments that, like EPO, are designed to replace deficiencies of the body's own internally manufactured chemicals. Biologics are tough to copy, and until now, companies making them have rarely faced generic competition. And with two more Eprex copies recommended for E.U. approval--one from Novartis unit Hexal and another from Medice Arzneimittel Puetter--it appears that the salad days in biologics are coming to a close.