Biosimilars are coming for Regeneron and Bayer’s Eylea’s crown, but the blockbuster reign is under no immediate threat of being overthrown.
That’s according to a new joint analysis from analysts with Piper Sandler and Spherix Global Insights, which finds ophthalmologists are serving up a “tepid reception” to emerging biosimilar rivals that target other medicines in the vascular endothelial growth factor (VEGF) category.
Spherix asked 75 eye doctors late last year about their views of copycat drugs and Regeneron/Bayer’s $8.3 billion-a-year behemoth. Piper Sandler, combing through the data, said the bottom line was that it found “a physician group that is highly satisfied with Eylea and largely ambivalent with regard to biosimilar options.”
For the two marketed VEGF biosimilars, Mvasi and Zirabev, which reference Roche’s Avastin, doctors “are generally ambivalent,” Piper Sandler analysts wrote in a note to clients. The docs report “modest share and importantly little financial incentive to use,” and they also have some concerns over efficacy and safety for the two drugs. Avastin, approved to treat certain cancers, is sometimes used off-label to treat age-related macular degeneration.
The tepid feedback extended to Samsung Bioepis’ Byooviz, the biosimilar to Roche and Novartis’ $1.46 billion-a-year eye drug Lucentis. The docs have “low familiarity and intent to prescribe once launched,” the analysts wrote. The biosim is expected to debut in June of this year.
Considering the results, the analysts “continue think biosimilar availability (for Lucentis or Avastin) is not a threat to Eylea,” they wrote. Biosimilars to Eylea are not expected until next year at the earliest.
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Outside of biosimilars is a different threat posed by Vabysmo, the new bispecific eye drug out from Roche which launched just this month. The recent FDA approval in wet-age related macular degeneration and diabetic macular edema makes it the lone injectable therapy approved simultaneously in the U.S. for both conditions.
A key advantage for Vabysmo could be its more flexible dosing regimen. While Eylea is administered once every one to two months, Vabysmo—after a series of four monthly injections—can be taken once every one to four months depending on the patient’s vision outcomes and the anatomy.
But analysts at Evaluate see sales for Vabysmo hitting just $1.1 billion by 2026, far off the major cash haul Eylea brings in each year. Besides, Regeneron is working on a higher-dose version of Eylea which could be administered every four months, countering this threat.
Spherix fielded its survey just before the approval of Roche’s Vabysmo, so the Piper Sandler analysts think the next logical questions center on how that new launch may impact this feedback.
RELATED: Roche pharma CEO Anderson talks up Vabysmo’s ‘very strong launch’ plans as Eylea battle looms
In the near term, however, the firm is “comfortable” with its at-consensus Eylea U.S. sales (which go to Regeneron) estimates of $6.2 billion and $6.16 billion for this year and next.
“Eylea is king, and expected to remain as such at least in the near term,” Piper Sandler concluded.
