The FDA just approved ranibizumab-eqrn (Cimerli, Coherus), a biosimilar that’s interchangeable with Lucentis.
Remind me, what is a biosimilar?
Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product and have no clinically meaningful differences in terms of safety, purity, and potency.
And biosimilars are different from generics because ...?
Biosimilars and generics have similarities. Both are marketed as cheaper versions of the name brand drugs and are available when drug companies’ exclusive patents for those drugs expire.
They are also both designed to have the same clinical effect as the name brand drug.
The main difference is that generic drugs are identical to the original in chemical composition, whereas biosimilar drugs are “highly similar,” but close enough in duplication to accomplish the same therapeutic and clinical result. (via)
This all sounds familiar.
Probably because Byooviz, the first biosimilar in ophthalmology, was approved last year with an indication for the treatment of wet AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
How is this one different?
Ranibizumab-eqrn has five indications: wet AMD, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The extra indications involve additional FDA requirements that allow substitution without intervention of the prescribing clinician.
When will this be available?
The commercial launch of ranibizumab-eqrn in the United States is planned for early October in both 0.3 mg and 0.5 mg doses. (via)