Coherus wins FDA approval for second Lucentis biosimilar, its third drug

Dive Brief:

• Coherus BioSciences will have an edge as it moves to market the second copycat version of the top-selling eye medication Lucentis.
• The California biotech on Tuesday won Food and Drug Administration approval of its drug, Cimerli, as an interchangeable biosimilar of Lucentis, sold by Roche. The first Lucentis biosimilar approved, Biogen and Samsung Bioepis’ Byooviz, did not get interchangeable status, which comes with a year of exclusivity for that type of labeling.
• Coherus said sales of Cimerli will begin in October. The company’s shares rose in early trading Wednesday, before falling back.

Dive Insight:

To win the interchangeable designation, Coherus had to meet additional requirements set by the FDA for all five indications for which Lucentis is sold. The label gives doctors and pharmacists additional flexibility, allowing them to make substitutions as they routinely do for traditional drugs and their generic versions.

Like Lucentis, Cimerli is approved for retinal conditions, including wet age-related macular degeneration and diabetic retinopathy. Developed by Roche’s Genentech unit, the brand-name drug is sold by Novartis in Europe and had global sales of about $3.5 billion last year.

Because of various patent rights held by Genentech, Biogen didn’t launch Byooviz until June. The company said its biosimilar would be sold at a 40% discount to Lucentis, or about $1,130 for a vial of the 0.5 mg injection. A Coherus spokesperson declined in an email to give pricing information for Cimerli, which will be sold in both 0.3 mg and 0.5 mg doses.

With Cimerli, the FDA has now approved 37 biosimilars, including four this year. Congress in 2010 cleared the way for the agency to allow “highly similar” biologic products onto the market, and the FDA approved the first one in 2015. But the effect on costs for patients has been less than advocates had hoped because of broad patent estates held by pharmaceutical companies and modest discounts to brand-name products.

Coherus already sells a biosimilar of bone marrow stimulant Neulasta in the U.S. and has won FDA clearance for a copycat version of autoimmune drug Humira that it plans to bring to market in 2023.

This post has been syndicated from a third-party source. View the original article here.