Novartis Clears Hurdle For Generic Biotech DrugNovartis Clears Hurdle For Generic Biotech Drug

Novartis AG said on Friday that it has cleared another hurdle in its quest to put out a generic version of one of the biotechnology industry's most popular drugs: the blood-building therapy epoetin alfa, also known as Epogen or Procrit.

Novartis (NVS) said that a panel of the E.U.'s Committee of Medicinal Products for Human Use has recommended that the generic version of epoetin alfa made by the company's Sandoz division be approved for use in the European Union. A final decision on the generic will be made by the European Commission.

Friday's announcement is the latest victory for Novartis and its Sandoz unit - - one of the world's largest manufacturers of generic drug -- in the company's on-going battle to put out generic versions of biologic therapies -- drugs that are made out of living proteins rather than chemicals.

Because of their complexity, regulators have been hesitant to approve generic versions of biologics, even though many are facing patent expirations. In the case of the E.U. and U.S., the current systems for approving generics were designed for chemically-based drugs, allowing for generic versions to be approved with only limited clinical testing in order to keep down costs.

Health experts, however, have argued that generic biologics need far more rigorous testing in order to ensure safety. How much additional testing has become a hot topic of debate on both sides of the Atlantic.

Epoetin alfa, which is based on the human protein erythropoietin, is used to treat anemia associated with kidney disease and chemotherapy. The drug is marketed by Johnson & Johnson (JNJ) in Europe under the brand name Eprex, and in the U.S. under the name Procrit.

Amgen (AMGN) , which co-developed the drug, markets it in the U.S. under the name Epogen. Although Amgen has launched a next-generation version of Epogen called Aranesp, Epogen is still a major driver for the company.

Novartis estimated that epoetin alfa had sales of more than $7 billion in the U.S. and $600 million in Europe.

Last year, Novartis won approval for the first generic biologic in Europe, the growth hormone Omnitrope. The U.S. Food and Drug Administration finally approved Novartis' version last year after the company sued the agency for dragging its heels on making a decision.

The FDA had argued that it did not have a regulatory pathway for approving generic versions of biologic drugs, eventually approving Novartis' version as a "follow-on" product to the original rather than an actual generic product.
source:money.cnn.com