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The Biologics Wave Has Come Ashore

MANAGED CARE May 2014. © MediMedia USA
The Formulary Files

The Biologics Wave Has Come Ashore

Michael D. Dalzell

For years, payers, benefit-design specialists, and others have talked about the “biologics wave” — a tsunami of costly targeted biologics and other specialty drugs achieving FDA approval. In 2013, the wave crashed ashore.

Of the 27 drugs receiving FDA approval in 2013, 13 are biologics and specialty drugs. A new report from Evaluate Pharma predicts that six will be blockbusters within five years. The authors estimate that, collectively, the six will rack up $17 billion in annual sales by 2018.

6 ‘billion-dollar babies’

Annual sales in 2018 (in billions)

Source: Pharma & Biotech 2013 in Review, Evaluate Pharma, London, March 2014

Sales predictions are based in part on a drug’s potential for expanded labeling. Several of the Big 6 are under study for uses beyond their initial indication:

Out of the pipeline, ready to grow
Approved in 2013 Initial indication Current clinical studies
Sofosbuvir Hepatitis C (HCV) HCV, as part of a fixed-dose combination with ledipasvir (phase 3)a
HCV, as part of a fixed-dose combination with GS-5816 (phase 2)a
Ado-trastuzumab emtansine HER-2+ metastatic breast cancer in previously treated patients HER-2+ metastatic breast cancer in treatment-naïve patients (phase 3)b
Ibrutinib Mantle cell lymphoma Multiple studies of hematological cancersc
Obinutuzumab Treatment naïve patients with chronic lymphocytic leukemia Diffuse large B-cell lymphomab
Front-line indolent non-Hodgkin lymphomab
Refractory indolent non-Hodgkin lymphomab
Front-line chronic lymphocytic leukemiab
Sources: aGilead Sciences; bGenentech; cNational Cancer Institute

Of course, unforeseen events — emergent safety issues that result in market revocation, a patent suit, or FDA rejection of a new indication — mean all sales bets are off.