Clinical therapeutics
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Clinical therapeutics · Feb 2012
ReviewBiosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innovator biologics, as well as an increase in the number of these products reaching patent expiry, the development of a process for approving biosimilar products has become a crucial regulatory issue in the United States. ⋯ This commentary provides evidence that current EU guidelines have resulted in the approval of biosimilar therapeutics with comparable efficacy and safety profiles for the recommended indications of their respective reference originator biologics. It is anticipated that these precedents will serve as a starting point in the development of a process for approving biosimilars in the United States and worldwide to provide efficacious and tolerable biotherapeutics with a significant cost advantage for national health care programs and consumers.
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Clinical therapeutics · Feb 2012
Effect of statins on total cholesterol concentrations, cardiovascular morbidity, and all-cause mortality in chronic obstructive pulmonary disease: a population-based cohort study.
The benefit of statin use on total cholesterol (TC) concentration has not been studied previously in patients with chronic obstructive pulmonary disease (COPD). ⋯ In patients with COPD, statins were protective from CV events and CV mortality in SP but not PP, and statins improved all-cause mortality in both PP and SP.