The US FDA’s verdict on Biogen’s aducanumab is one of the biggest events on biopharma’s 2021 calendar. And the Alzheimer’s antibody owns another accolade: of the novel projects slated to reach the market this year, aducanumab attracts the sellside's highest revenue forecasts.
With the outcome far from certain, numbers are likely to be heavily risk-adjusted, but for now consensus sits at $4.9bn for 2026. That puts aducanumab way out in front of the other potential new arrivals: Argenx’s efgartigimod, in second place, boasts a consensus of $2.5bn.
It is important to note that the $4.9bn figure for aducanumab is combined sales being allocated to Biogen and Eisai, which will co-promote the project – if approved. A collaboration sees the companies share different proportions of profits, depending on the region.
For the antibody to reach the market in 2021 the FDA must rule against its advisory committee, which voted almost unanimously against approval. The agency typically sides with these panels; however, supportive FDA documents and the high-profile nature of the decision makes the outcome hard to call.
Some considered news last week, that the Biden administration had asked Janet Woodcock to step in as interim FDA commissioner, as a good omen. Ms Woodcock had made the controversial decision to approve Sarepta’s Exondys 51 despite concerns about lack of evidence of its effectiveness.
|Waiting in the wings: biggest potential new launches in 2021|
|Project||Setting||Company||Status||2026e sales ($bn)|
|Aducanumab||Anti-beta amyloid MAb for Alzheimer's disease||Biogen/Eisai||PDUFA 7 Mar 2021||4.92*|
|Efgartigimod||Anti-FcRn MAb for IgG-mediated autoimmune diseases||Argenx||BLA submitted in myasthenia gravis||2.52|
|Evrenzo (roxadustat)||HIF-PH inhibitor for anaemia||Astrazeneca/Astellas/Fibrogen||PDUFA 20 Mar; EU approval Q1 2021; approved in Japan||2.30|
|Leqvio (inclisiran)||siRNA-based anti-PCSK9 for high cholesterol||Novartis||Approved in EU, CRL in US, as of Dec 2020||2.01|
|Bimekizumab||Anti IL-17A&F MAb for psoriasis||UCB||US and EU approvals expected mid-2021||1.62|
|TransCon Growth Hormone||Long-acting human growth hormone||Ascendis Pharma||PDUFA Apr 2021||1.47|
|Ide-cel||Anti-BCMA Car-T therapy for myeloma||Bristol Myers Squibb/Bluebird||PDUFA 27 Mar 2021||1.34*|
|AXS-05||NMDA receptor antagonist||Axsome Therapeutics||NDA for depression due Jan 2021 (US breakthrough status)||1.14|
|Liso-cel||Anti-CD-19 Car-T therapy for lymphoma||Bristol Myers Squibb||Nov 2020 PDUFA missed; no new date set||1.11|
|Voclosporin||Calcineurin inhibitor for lupus nephritis||Aurinia||PDUFA 22 Jan 2021||1.09|
|Source: EvaluatePharma. *Combined partner sales.|
Approval is far from guaranteed for any of these projects, with the pandemic adding an extra element of risk. Covid-19-related delays are a reality, hence the inclusion in this list of Novartis’s inclisiran, which should technically have been a 2020 approval.
In December Novartis received a complete response letter from the FDA because travel restrictions prevented the agency from inspecting a third-party manufacturing plant in time. New timelines have yet to be disclosed, but for now the sellside expects US launch this year; in December approval was won in Europe, where the product is now branded Leqvio.
Another rollover from 2020 is Astrazeneca and Fibrogen’s roxadustat, although the companies were unable to blame the pandemic for the three-month delay to its US decision. The FDA cited “clinical data analysis issues”.
The number of smaller developers on this list is notable this year. Access to capital and punchy valuations mean that many late-stage projects remain in the hands of their originators.
Of these, Argenx holds the most valuable asset, according to the sellside. The Belgian developer submitted a BLA for efgartigmod in myasthenia gravis in December, although the FDA has yet to officially accept the filing, a company spokesperson confirmed; this typically happens within 60 days of the filing.
Efgartigimod will enter a fiercely competitive space, and many might consider these forecasts highly optimistic. It goes without saying that none of these numbers is set in stone, of course, even if approval does arrive. It is probably also worth bearing in mind that biotech analysts covering smaller stocks are typically more bullish than big pharma analysts.
A case in point is mavacamten, which was bought by Bristol last year from Myokardia in a $13.1bn deal, and featured in this same analysis only a month ago. At that time Myokardia analysts were driving the 2026 consensus, which sat at almost $2bn. Now that Bristol analysts have taken over forecasting the figure has dropped to $903m.
While this might be a more realistic projection for mavacamten, the sellside tracking Bristol is certainly not afraid of big numbers. Expectations for the two Car-T therapies that the company has up for approval this year look very optimistic, given the crowded fields that they are targeting – assuming they get to market in the first place.
(A recent version of this analysis is available in Evaluate Vantage's 2021 Preview, which is free to download.)
This story has been updated to include comments from Argenx regarding its FDA filing.