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The FDA last week announced the availability of the most recent cumulative list of orphan drug and biological designations as of Dec. 31, 2003. The list includes the name of the drug or biologic, the condition/disease for which the drug or biologic is indicated and contact information for product sponsors.
Generic drugmaker Sandoz intends to become the first firm to launch a generic biologic by putting its human growth hormone product Omnitrop on the market in Europe next year.
Generic drugmaker Sandoz expects to launch the first generic biologic on the market — its follow-on human growth hormone product Omnitrop — next year in Europe.
Unlike the boom-bust cycle in the biotech industry four years ago, current growth in the market may be sustainable based on a more rational view of individual biotech firms and an increasing awareness of the products’ potential to yield innovative healthcare, say industry analysts in a new study.
After a sharp market downturn in the previous two years, the biotech industry started to surge in 2003, driven in part by a critical mass of biological drugs on the market and many experimental products on the verge of gaining FDA approval, a new study finds.
Unlike drugs developed in the 20th century and earlier that were designed to treat diseases after symptoms appeared and normal function had been lost, drugs created in the 21st century will be used to intervene before symptoms are evident and preserve normal function for extended periods, a top U.S. science official has predicted.
The biotechnology industry is looking for a great deal more FDA guidance on how to navigate the drug approval process for biological products, according to an industry attorney.
Approving a generic biologic would require the FDA to rely on an innovator firm’s trade secret data covering the product’s manufacturing process — something that is prohibited by law, argues biotech firm Genentech.
Rather than looking to reimportation or price controls as remedies to the high cost of Rx drugs, the U.S. should work to ensure that European and other industrialized nations shoulder their share of the development burden, according to the Massachusetts Biotechnology Council (MBC).
Concerned over the FDA’s growing momentum toward developing an approval process for generic biologics, a U.S. senator has urged the agency to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.