Coherus eyes ophthalmology biosimilars prize

In-licensing a Lucentis biosimilar goes “hand-in-hand” with its internally developed Eylea biosimilar, says Coherus BioSciences.

Californian biosimilar developer Coherus acquired the US commercial rights in November to commercialize a version of Lucentis (ranibizumab) from Bioeq, a joint venture between Polpharma Group and Strüngmann Group.

The ophthalmic monoclonal antibody pulled in US sales of CHF 1.83 billion ($1.9 billion) for Roche/Genentech in 2019.

Image: iStock/Vicu9

Concurrently, Coherus has a biosimilar candidate looking to take on Regeneron’s Eylea (aflibercept) in the form of CHS-2020. Eylea is an anti-VEGF medication that’s administered by an injection into the eye to treat wet age-related macular degeneration (AMD) and other eye conditions, and pulled in sales of $4.6 billion for Regeneron last year.

According to Coherus CEO Dennis Lanfaer, having the internally developed Eylea biosimilar and the bought-in ranibizumab candidate provides a robust strategy to compete in the $6 billion anti-VEGF US market.

“We like the synergy that we are currently pursing with having in-licensed products in tandem with internally developed products,” he told stakeholders on a financial call. “I think a prime example of that is Lucentis biosimilar hand-in-hand with Eylea biosimilar. It balances the launch timing.”

The CHS-2020 biosimilar is now in a position to “initiate commercial scale, GMP manufacturing efforts in support of the expected Phase III clinical trials in 2021 with launch projected in 2025,” he continued, while Coherus is supporting Bioeq to support a resubmission of the ranibizumab biosimilar to the US Food and Drug Administration (FDA).

Last month, the US Agency requested additional data as part of the review process of the Biologics License Application (BLA) for the Lucentis biosimilar candidate, submitted by Bioeq in December 2019. The data specifically referred to the move of a piece of processing equipment at the drug substance contract manufacturer’s plant to a different location within the same site.

“We are currently focused on supporting our partner to generate the additional manufacturing data as requested by FDA and expect to resubmit the application upon completion of these efforts and certain regulatory interactions,” said Lanfaer.

Udencya biosimilar boost

For the full year, Coherus reported product revenue of $356 million, driven by the approval and January 2019 launch of Udencya, a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

“With respect to the company’s commercial performance of Udencya, we are very pleased we met our goal of achieving 20% or more market share by the end of 2019,” Lanfaer said.

“One year after launch, the success of Udenyca has validated our biosimilar business model. As a result, our pipeline strategy is now focused on leveraging our R&D and commercial strengths in selected therapeutic areas that can provide the greatest value to patients and the healthcare system while also generating the best return for our shareholders.”