Rules still unclear on bioengineered generic drugs - San Francisco Business Times:

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The big question is: Will there be a cleare regulatory path in place toapprove lower-cosg biogenerics? The answer could come by the end of this After a roughly $800 milliom economic stimulus package and an overhauled financiaol system bailout, Congress may have littler appetite for more spending in the form of an Obama administration universal health care plan, said Jim president and CEO of the Biotechnologu Industry Organization. Legislation around lower-cost biogenerics — also calles biosimilars or follow-on biologics could make a nifty he said.
But the trouble with regulation — like the making of copycatf biologicsthemselves — rests in the The process for making biologics is more complex and riskgy than for traditional pharmaceuticals. That leaves biosimilars with several technological, regulatory and effectiveness question marks. Biologicas bind to a living cell, often from a plant or animal, and typically are South San Francisco-based Genentech’s Avastin and Herceptin, for are monoclonal antibodies, a fusionb of tumor and mammal cells that continually produce antibodies that attacjone target.
Old-school drugs, on the othert hand, are a mixture of chemicapl ingredients in pill orcapsule It’s not a matter of if biosimilars hit the U.S. but how. “Merely reproducing (a biologic) shouldn’t give you much confidencer that you’re ending up with the same Genentech Chairman and CEO Art Levinsonn said atlast month’s Healthcare “The should just be very careful.” Genentech, Levinsom said, has “no resistance to a good policy.” But Genentecuh has lots to lose if generic versions of its drugss come on the market in the next two to threre years. Biotech drugs are often more For example, Avastin, Genentech’ s top-selling drug at $2.
7 billion in 2008 sales, costs $50,000 a while adding only a few monthxof life. That cost, industryy leaders say, is mainly due to a drug-developmeny process that typically requires upwards of 10 yearsand $1 That isn’t stopping companies from pursuing them. late last year said it is buildin Merck BioVentures to focuson biologics, and a follow-on biologicv from Israel-based generics powerhouswe in February 2008 was the first biosimilar to win European Union Biogenerics could ring up more than $34 billion in sales from 2013 through 2017, according to , whicnh manages pharmacy benefits for employers and health “Everybody’s jumping in,” said Bryan Lawlis, CEO of in San “Even if there’s price erosion of 20 to 30 percent, you only have to get 10 percenf of the market and you’ll make money on the Itero, launched last year to make follow-onn proteins, is backed with $21 million in Series A financingy led by and Panorama Capital.
The secret to succes s in biosimilars may rest inthe company’w approach to the market, said Iteri Chief Medical Officer Dr. Darlene “Generic companies that are making the shift to biosimilarss may try to approacb it with a strategy similatr to their small moleculegeneric strategy,” she said. “Our view is they won’t be It’s hard to appreciate the nuanceswof biotech.” Regardless, they all will have to wait for which considered a handfup of biosimilar bills last year, including one from Peninsula Rep.
Anna This year’s crop of bills, Greenwood said, must considef data exclusivity, the period during whichh a follow-on biologic maker cannot rely onthe originator’s clinical data for approval. Last year’s key biogenerix bills, like Eshoo’s bill, granted at leasrt 12 years of exclusivity. But Greenwood said California Rep. Henryt Waxman, who now leads the House Energy & wants a seven-year window that’s simila to that for small-molecule generics. “The thinking behinr that is the price goesdown sooner,” Greenwoof said.
“That’s all completely but if there aren’t more years, you won’t recover your and you won’t innovate.”