American Academy of Ophthalmology biosimilars guidance details

Biosimilars/General | Posted 01/07/2022 post-comment0 Post your comment

The American Academy of Ophthalmology (AAO) recognizes the potential societal value of biosimilars for improving care of patients with eye disease.  Biosimilars should have sufficient research demonstrating their safety and effectiveness for treatment of eye disease. In January 2022, the AAO issued a policy statement on the biosimilars in ophthalmologic use [1].

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The guideline outlines that, for an ophthalmic biosimilar, a comparative clinical trial is generally required in addition to a similarity comparison [2]. It discusses other aspects of biosimilars in general, such as the US’s interchangeability designation [3].

Details of the recommendations in the policy statement are as below.

Prescribing Biosimilars
Across the US, state rules vary for pharmacist substitution of biosimilars, and these should be reviewed by each treating ophthalmologist. When a different biosimilar is suggested by a pharmacist or the insurer, the ophthalmologist should review the biosimilar's approved indications. The Academy strongly recommends against biosimilar substitution for off-label use and recommends ophthalmologists assess any legal risk associated with use of biosimilars without US Food and Drug Administration (FDA) approval for intravitreous use.

Economics of biosimilar use in eye care
Although biosimilars can reduce healthcare costs, their use should be supported by clinical evidence and FDA approval. In ophthalmology, biosimilars are not always the cheapest option, e.g. off-­label bevacizumab can be less expensive than on-label reference products and new biosimilars.

Formulary inclusion of biosimilars
When biosimilars are added to coverage by insurers (formularies), they must have robust clinical literature supporting their use for ophthalmic diseases. Ideally, ophthalmologic biosimilars should be listed in the FDA Clinical Outcome Assessment (COA) Compendium and include clinical literature supporting safety and efficacy.

Step therapy using biologicals
The Academy does not support step therapy approaches unless all treatment options are approved specifically for ophthalmic indications. Step therapy is used by insurers to bring healthcare costs down and it requires use of the least expensive treatment first, only moving on to more expensive options if necessary. The Academy states that treatment should be chosen by the patient and their ophthalmologist.

FDA-approved biologicals and biosimilars
The Academy supports the use of biological medicines approved for ophthalmic use by the FDA. Byooviz (ranibizumab­nuna) was the first biosimilar approved for ocular therapy in the US [4-6]. covering treatment of neovascular age-related macular degeneration, myopic choroidal neovascularization and macular oedema following retinal vein occlusion. Biosimilars of aflibercept and bevacizumab are under development [8].

Bevacizumab biosimilars used off-label in the eye
Bevacizumab has been approved by FDA for the treatment of various cancers but not for ocular therapy. The Academy notes that it has been widely studied in eye disease treatment and in 2020 was used in approximately half of intravitreal injections in the US.

Several bevacizumab biosimilars – MVASI (bevacizumab-awwb) and Zirabev (bevacizumab-bvzr) – have been approved in the US for use in the oncologic space. Certain payers are including these in their formularies and suggesting their use for ocular therapy. However, neither available biosimilar has been studied for ophthalmic indications and their inactive ingredients have not all been approved for use in the eye,

The Academy advises against use of bevacizumab biosimilars for ocular therapy unless specifically approved for this.

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References
1. The American Academy of Ophthalmology. The use of biosimilars in ophthalmic practice – 2022 [homepage on the Internet]. [cited 2002 Jul 1]. Available from: https://www.aao.org/clinical-statement/use-of-biosimilars-in-ophthalmic-practice
2. GaBI Online - Generics and Biosimilars Initiative. American Academy of Ophthalmology biosimilars position statement published [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/general/american-academy-of-ophthalmology-biosimilars-position-statement-published
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 Jul 1]. Available from: www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Phase III trial evidence used in approval of ranibizumab biosimilar byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: https://gabionline.net/biosimilars/research/phase-iii-trial-evidence-used-in-approval-of-ranibizumab-biosimilar-byooviz
6. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
7. GaBI Online - Generics and Biosimilars Initiative. Clinical trials for aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/news/clinical-trials-for-aflibercept-biosimilars

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