In a couple of firsts, the U.S. Food and Drug Administration (FDA) approved the second biosimilar ranibizumab on August 2, but the first as an interchangeable ranibizumab agent and the first as an interchangeable that did not require extensive switching studies for approval.
The new biosimilar, named Cimerli (ranibizumab-eqrn), will be marketed in October 2022 by Coherus Biosciences. This agent, the product of a developmental partnership between Coherus and Bioeq (which is a joint venture between Polpharma and Formycon AG), was granted 180 days of exclusivity for its interchangeability designation.
Cimerli is approved and interchangeable for all five of Lucentis’ indications:
- Neovascular (wet) age-related macular degeneration
- Macular edema after retinal vein occlusion
- Diabetic macular edema
- Diabetic retinopathy
- Myopic choroidal neovascularization
This approval is notable because the FDA’s approval is based on the usual pharmacokinetic and pharmacodynamic comparability data but only on a head-to-head study against Lucentis, not a switching study between the two. This is a departure for the FDA, which could lower the bar in terms of complexity and cost for other biosimilar makers seeking an interchangeability designation.
However, the interchangeability designation in the case of Cimerli may not be extraordinarily meaningful. Ranibizumab is typically injected intravitreally in a physician’s office. As a result, it is less frequently covered under the pharmacy benefit (though it may be distributed by specialty pharmacies to the clinician’s office, rather than purchased by the physician through a buy-and-bill arrangement). Therefore, it is far less likely to be substituted automatically for the reference brand.
Samsung Bioepis received approval for Byooviz® as the first ranibizumab biosimilar in September 2021 and began marketing this agent in July 2022. The next likely FDA decision in this category will be for Xbrane Biopharma’s biosimilar, which is expected shortly.
