BIOTECH DRUG OKS COULD STALL FDA SHIFT MAY MEAN LONGER APPROVAL WAIT.

Byline: Evan Pondel Staff Writer

THOUSAND OAKS - Analysts say Amgen and other biotechnology titans won't necessarily benefit from the government's decision to review biologics and chemically based drugs with the same research unit.

The Food and Drug Administration said Friday that it will shift responsibility for approving new biotech drugs - derived from living organisms - to its unit that had previously focused on traditional drugs. In the past, the industry has complained that the review process for biological drugs was too slow.

``But just because that review process may be more efficient now, I don't think it's an instant positive for Amgen or the industry,'' said Jennifer Chao, analyst with RBC Capital Markets in New York. ``The expertise of the FDA's biologics division will be lost with the new change.''

In the past, the FDA relied on its Center for Biologics Evaluation & Research division for the approval of drugs manufactured by Thousand Oaks-based Amgen. But now, any new drugs produced by Amgen or other biotechnology companies will be reviewed by the Center for Drug Evaluation and Research.

The FDA said the consolidation would enable its biologics unit to focus on ``the crucial areas of vaccines and blood safety.''

Amgen shares rose $1.55, or 3.59 percent, to close at $44.75 Friday on the Nasdaq market.

Fariba Ghodsian, analyst with Roth Capital Partners LLCs in Los Angeles, said investors perceived the FDA's move as positive because CDER ``knows more about the whole approval process.''

``Despite that perception, because CDER is not as familiar with biologics as CBER, it could take a lot longer for some of these drugs to be approved,'' Ghodsian said. ``At least Amgen's Neulasta and Aranesp are already through the gates.''