FirstWord Lists: The $5 billion club – revisiting pharma's best-selling drugs of all time

Recent news flow – concerning key drug approvals in 2015 (FirstWord Lists – The biggest drug approvals of 2015) and both commercial and regulatory momentum for biosimilars – provides a relevant opportunity to revisit the biggest selling drugs of all time by peak-year sales.

Based on the annual revenues it recorded in 2006 , Pfizer's statin therapy Lipitor retains its status as the biggest selling drug in a single year, although this credential is under threat from AbbVie's TNF-inhibitor Humira and Gilead's Sovaldi/Harvoni franchise for the treatment of hepatitis C.

It is the presence of Humira – alongside Remicade and Enbrel – as perennial $5 billion-plus sellers that has attracted the interest of biosimilar developers; Johnson & Johnson's Q2 results, which were announced last week, hint at biosimilar competition for Remicade in Europe, with Merck & Co.'s second quarter results later this month likely to provide a better indication.

Biosimilar versions of Sanofi's long-acting basal insulin are expected to launch over the next 18 months in Europe and the US, while Roche's three biggest selling oncology products – Rituxan, Herceptin and Avastin – also continue to attract biosimilar attention.

New drugs which have been approved this year also threaten to re-write this list by the end of the decade, with forecast sales for Pfizer's Ibrance (breast cancer) and Novartis Entresto (heart failure) expected to approach $5 billion by 2020.

See Physician Views Poll Results: Entresto applauded but Novartis' prediction of a slower uptake looking accurate? and Physician Views Poll Results: Oncologist feedback confirms impressive sentiment towards Pfizer's Ibrance

How close the PCSK-9 inhibitors – Sanofi and Regeneron's Praluent and Amgen's Repatha – come to replicating the commercial success of the statins remains unclear. Both are forecast to generate sales in excess of $2 billion by 2020, but to put these figures in context Pfizer's Lipitor still commands sales of that magnitude some four years after US and European patent expiry.

Bristol-Myers Squibb's PD-1 inhibitor Opdivo is expected to be included in this somewhat exclusive club by 2020, with competitor products being developed by Merck & Co. and Roche also expected to be generating sales on a trajectory towards $5 billion by the end of the decade.

Showcasing that mass market and rare disease focus can support comparable levels of success, Biogen's multiple sclerosis treatment Tecfidera and Alexion's Soliris are both forecast to record sales in excess of $5 billion by 2020.

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