The days of market exclusivity could soon come to an end for the biotech industry if Congress moves forward with plans to finally allow generic biologics on the U.S. market.
Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.
But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.
Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.
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