Fewer drug and biologic approvals in 2013


Michael D. Dalzell

Thirteen of the 27 drugs receiving Food and Drug Administration approval in 2013 were biologics and other specialty pharmaceuticals. It’s the first time since 2009 that more than half of FDA approvals were for conventional drugs.

That the number of specialty drugs and biologics making it to market slipped from 25 in 2012 to 13 last year doesn’t mean that small molecules are back in vogue. On the contrary, a report released late last year by the Tufts Center for Drug Development noted that big pharma has made a dramatic shift in its R&D focus from small-molecule drugs to biotechnology.

Cancer continues to be a hotbed of specialty drug development. Of the 13 specialty drugs and biologics approved last year, 9 carry oncology indications and hefty price tags. None were chemotherapies.

Share of specialty drugs among FDA drug approvals, 2009–2013

2013 drug-approval timeline
Trade nameUseCosta
KynamroHomozygous familial hypercholesterolemia$176,000b
PomalystMultiple myeloma$10,500
KadcylaBreast cancer$9,800
TecfideraMultiple sclerosis$55,000b
XofigoProstate cancer$69,000c
MekinistMelanoma$8,700
TaflinarMelanoma$7,600
GilotrifLung cancer$5,500
TivicayHIV$1,175
GazyvaChronic lymphocytic leukemia$41,300d
ImbruvicaMantle cell lymphoma$11,000
OlysioHepatitis C$66,360e
SolvaldiHepatitis C$28,000f
aCost per month, unless otherwise noted.
bPer year.
c6-injection course of therapy.
d6-month course of therapy.
e3-month course of therapy.
fBottle of 28 tablets.
Pricing sources: Bioworld.com, Drug Discovery.com, Fierce Biotech, Huffington Post, Kantar Health, Medical Marketing & Media, Myelomabeacon.com, Nature, PharmExec.com, San Francisco Business Journal, UBC/Express Scripts, WebMD

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