American Academy of Ophthalmology biosimilars position statement published

Biosimilars/General | Posted 10/06/2022 post-comment0 Post your comment

The American Academy of Ophthalmology issued a policy statement on the use of biosimilars in ophthalmic practice in January 2022 [1].

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The statement outlines that for ophthalmic biosimilars, systemic pharmacokinetics are not predictive of safety or efficacy, and thus a comparative clinical trial is required in addition to a similarity comparison. Such trials are of similar duration (generally 9 months) and biosimilars require only one comparative efficacy trial, rather than two (as is required for a reference product). In addition, it highlights that, in the US, some biosimilars can be awarded interchangeable status if they meet certain stringent requirements and that allows them to be substituted at the pharmacy level in many states [2, 3].

The policy statement makes several recommendations related to:
Prescribing biosimilars
Economics of biosimilar use in eye care
Formulary inclusion of biosimilars
Step therapy using biologicals
FDA-approved biologicals and biosimilars
Bevacizumab biosimilars used off-label in the eye

Details of these recommendations are outlined in [4].

Overall conclusions
The Academy supports only the use of biologicals and biosimilars that have been FDA-approved for ophthalmic conditions. In addition, they are behind the idea that the choice of biological product should be that of the treating ophthalmologist and their patient. Although there has been successful and cost-effective off-label use of bevacizumab for eye diseases for over 15 years which is a unique history of a well-studied biological agent injected into the eye, which has yet to be duplicated for bevacizumab biosimilar, therefore, they should be used with caution.

Before a biosimilar is required to be used for treatment or included in a step therapy regimen, it should be FDA-approved for the ophthalmic indication, otherwise, the treating ophthalmologist should review the published evidence of safety and effectiveness for any biosimilar proposed for treatment with each patient to determine if it is the best clinical option.

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1. The American Academy of Ophthalmology. The use of biosimilars in ophthalmic practice – 2022 [homepage on the Internet]. [cited 2002 Jun 10]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Clinical evidence for interchangeability of biosimilars in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www://
3. U.S. Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. Guidance for industry. May 2019 [homepage on the Internet]. [cited 2022 Jun 10]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. American Academy of Ophthalmology biosimilars guidance details []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10].

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