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Roche says it is undeterred by upcoming biosimilar threat to Vabysmo

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Roche’s competition in the eye disease space is intensifying with Regeneron’s high-dose Eylea and a looming biosimilar challenge, but the Swiss pharma said its blockbuster eye drug Vabysmo is holding strong.

“We’re extremely pleased with the momentum that we see with Vabysmo in the US market and we would expect to see that to continue, especially given that we’ve just introduced the pre-filled syringe,” Roche’s pharma chief Teresa Graham said in a media call Wednesday. The company has already seen 80% conversion to the pre-filled syringe from the original vial packaging, she added.

But the entrance of Eylea biosimilars could challenge Vabysmo’s momentum. On Tuesday, Amgen said it is moving forward with the launch of its Eylea biosimilar called Pavblu following an appeals court decision against Regeneron. A Roche spokesperson told Endpoints News in an email that the company is “prepared for market entry [of biosimilars] under any timing.”

While Eylea blocks VEGF and PlGF, Roche’s drug acts on VEGF and Ang-2, which is a protein that helps regulate vascular remodeling and inflammation. Vabysmo’s “unique mechanism of action, the high level of drying that we’re seeing and the durability positions it extremely well against all of the products that are currently in the market,” Graham said.

The pre-filled Vabysmo syringe won FDA approval in July for wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion, offering a ready-to-use alternative to the Vabysmo vials. The drug’s third-quarter sales reached CHF 1 billion ($1.6 billion), up 59% from the same time last year.

Last year, the FDA greenlit Regeneron’s high-dose version of Eylea for wet AMD, DME and diabetic retinopathy. That same year, the Eylea franchise reached $5.9 billion in sales, which was significantly ahead of Vabysmo’s CHF 2.4 billion ($2.8 billion). Roche’s drug was later to market than Eylea. Nonetheless, Vabysmo shot to blockbuster status during its first full launch year after an approval in 2022.

As for Roche’s pipeline, the company dropped several early- to mid-stage programs, including its PD-1xLAG3 antibody tobemstomig, which was in Phase 2 development for solid tumors. Other cuts included Phase 1 multiple myeloma asset forimtamig and some candidates for hepatitis B.

The Swiss drugmaker said it is still interested in anti-tau approaches in Alzheimer’s disease, despite ending its partnership with UCB for a tau-targeting antibody. Graham described the termination as a “portfolio prioritization-driven decision.” The company’s Genentech unit is working with Sangamo to develop an epigenetic repressor to prevent the production of tau protein.


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