2020 U.S. sales: $1.61 billion
Disease: Wet age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy
Potential generic entry: Second half of 2021
Roche’s wet age-related macular degeneration (AMD) drug Lucentis faced new competition when Novartis launched Beovu in October 2019. But this year the whole class of drugs could face an entirely new challenge: biosimilars.
Last November, Samsung Bioepis said the FDA agreed to review its biologics license application for SB11, a biosim referencing Lucentis. The acceptance “brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” Samsung Bioepis executive Hee Kyung Kim said at the time.
The drug will be reviewed in a standard 12-month timeline, a Samsung Bioepis spokesperson said.
Biogen has a 49.9% stake in Samsung Bioepis and will commercialize the biosimilar in the U.S. and other key markets, the company said in a recent investor presentation. Biogen will also market a biosimilar targeting Regeneron’s Eylea, though that's unlikely to happen this year.
Roche said in its annual report that there are “recent and approaching patent expiries in the US for Lucentis which may have an impact on 2021 sales for this product.” The drug generated 1.44 billion CHF ($1.61 billion) in the U.S. last year, a 16% decline from 2019, as COVID-19 caused patients to delay or cancel treatments.
Other experts see a likely 2021 biosimilar launch, as well. OptumRx has said a second-half rollout is reasonable to expect, while Piper Sandler analyst Christopher Raymond predicted in a note last October that Lucentis biosimilars could be available in 2021.
While the pandemic disrupted the Lucentis market in 2020, it also slowed the rollout of Novartis' Beovu, which was already complicated by safety concerns. Still, Novartis is focused on pitching the drug, which generated $190 million during its first full year on the market.
The leading AMD drug on the market, Regeneron’s Eylea, pulled $4.95 billion in 2020, a 7% increase from the prior year despite challenges associated with the pandemic.
As Samsung Biopeis and Biogen appear ready to launch in 2021, another potential Lucentis biosim from Coherus is waiting in the wings. That company aims to help partner Bioeq submit its FDA application for a Lucentis copy this year, Coherus said.