Sanofi/Regeneron celebrate better late than never 

Libtayo is the third anti-PD-1 antibody to be approved in the US, Sanofi and Regeneron heralded on Friday, in the wake of the FDA nod for cemiplimab. This is an accurate yet slightly misleading boast, considering that three checkpoint inhibitors that hit PD-L1 are also already on the market. Semantics aside, the sellside is forecasting fairly respectable demand for what is essentially sixth to market in its class. The drug has been approved to treat metastatic cutaneous squamous cell carcinoma, an aggressive tumour with few existing options. By targeting an underserved market Regeneron and Sanofi have adopted a similar strategy to Pfizer and Merck KGaA with Bavencio; interestingly, the commercial future for the two products looks to be around the same size. Additional growth for Libtayo could come from new indications, and the most advanced are phase III trials in various lung cancer settings, although here the companies will move into very competitive territories. Meanwhile, a pivotal study in metastatic cervical cancer could open another niche, though Merck & Co's Keytruda is already approved second-line in PD-L1-positive patients. 

Third to market? How the anti-PD-(L)1 market is seen shaping up
      Annual sales ($bn)
Product Mechanism Company 2018e 2021e 2024e
Keytruda Anti-PD-1 MAb Merck & Co/Otsuka 6.9 12.1 14.5
Opdivo Anti-PD-1 MAb Bristol-Myers Squibb/Ono 7.2 9.4 11.4
Tecentriq Anti-PD-L1 MAb Roche 0.9 2.8 3.7
Imfinzi Anti-PD-L1 MAb AstraZeneca 0.5 2.5 3.4
Bavencio Anti-PD-L1 MAb Pfizer 0.07 0.4 0.6
Libtayo Anti-PD-1 MAb Sanofi/Regeneron  0.02 0.4 0.6
Source: EvaluatePharma.

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