Biologics Reached Record Share Of Novel Approvals In 2009
This article was originally published in Pharmaceutical Approvals Monthly
The pharmaceutical industry’s strategy of looking to biologics as a source of innovation is clearly demonstrated in FDA’s novel approvals in 2009.
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Some ideas for new drug approval pathways seem to envision the use of Risk Evaluation and Mitigation Strategies as a means for preventing and monitoring off-label use following initial approval, apparently without regard to the seriousness or extent of a product’s risks. Given the burdens currently created by REMS, any effort to expand and retrofit the programs to a new approval pathway is likely to draw pushback from the health care community.
Few, But Fast And On Time: 2010 Saw Low NME Count, But Almost All Were First-Cycle Approvals And FDA Met Most User Fees
The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.
Specialty firms again in 2010 dominated new molecular entity and novel biologic approvals, suggesting that the much-discussed pipeline drought facing big pharma has yet to improve.