Biosimilars in Ophthalmology: Trends and Potential

Abstract

Biosimilarsarebiotechnology-derivedproteinproducts which are almost identical to certain drugs which may be called spearhead or reference biologics. Biological and therapeutic effects of biosimilars are achieved in the same manner as the respective spearhead drug but in a speedy manner and at a low cost without diminishing comparative 1safety and efficacy.These specks are highly and vigorously researched, so they may be 100-1000 times larger in size than the generic or spearhead drug. The road to approval for biosimilars is different from that of generic biologics. Since the generic biologics have already been tested and given approval by Foodand Drug Administration, Biosimilars only need to show similar efficacy and safety profile as that of reference drugs (Phase 3 randomized clinical trial).

For anti-VEGF biosimilars, systemic pharmacokinetics is not prophetic of efficacy and safety. So, they have to be compared to spearhead biologic for nine months. Safety is compared throughout nine months while comparative efficacy is judged at the pinnacle of efficacy curve i.e. 6-8 2weeks after administration.Biosimilar is labelled by adding a 4 letter suffix to the original name of spearhead reference biologic to discern between the two i.e. Yesafilli (aflibercept-jbvf).