FDA Approves 3rd Interchangeable Biosimilar – Cimerli

biosimilar

The FDA just approved another biosimilar!

That’s always big news that often starts a panic in the healthcare industry…. said no one ever.

However, this new biosimilar is different as it was awarded the coveted interchangeable designation! Only two other biosims have been so lucky. For a new entrant to a very finite market….. with a well-entrenched brand….. that designation is a HUGE differentiator. 

Ok….here’s  the details.

The new biosim is called Cimerli  (ranibizumab-eqrn) from Coherus and is an interchangeable biosimilar product to Lucentis (ranibizumab injection) for all five the brand’s indications.

  • Neovascular (wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR), and 
  • Myopic Choroidal Neovascularization (mCNV) 

Cimerli isn’t the first biosimilar of Lucentis to be given the green light as the FDA approved Samsung Bioepis’ Byooviz in September of 2021.

Cimerli is administered by ophthalmic intravitreal injection only. It belongs to the successful anti-VEGF therapy class of biologics which generates billions in annual sales. Standard physician administered dosing is once monthly.

Commercial availability of Cimerli, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.

Coherus hasn’t yet released pricing for Cimerli. By way of reference, Byooviz launched on July 1st at a 40% discount to Lucentis, a list price of $1,130 per single-use vial.

CLICK HERE for full prescribing information

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