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0.00100571428571428 0.00267428571428575 0.00111542857142857 0.00155428571428573 0.00377142857142865 -0.00319999999999995 -0.00256000000000001 -0.00479999999999992
Stock impact report

New FDA guidance could elevate pharma's biosimilar market [Yahoo! Finance]

Cardinal Health, Inc. (CAH) 
Last cardinal health, inc. earnings: 2/6 06:55 am Check Earnings Report
US:NYSE Investor Relations: ir.cardinalhealth.com/home
Company Research Source: Yahoo! Finance
Since the FDA approved the first biosimilar 11 years ago, more than 80 biosimilars for various brand-name drugs have been given the go-ahead, reflecting major shifts in regulatory and industry priorities in the biologic arena. Now, the agency is paving the way for more approvals, hoping the smoother road will introduce competition and lower prices for consumers. This week, the FDA issued draft guidance that, in some cases, would lower the bar for biosimilar testing, allowing companies to develop copycat versions of biologic blockbusters for potentially half the R&D cost Biosimilars aren't easy to make. Unlike small molecules, which can be recreated using a chemical recipe, biologics and biosimilars are developed with live organisms. Even if a brand-name biologic is well established in the market, biosimilars need to be developed from the ground up and proven to be comparable — and at best interchangeable — with the original. Comparative studies alone can take up to three years Show less Read more
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