The Academy supports the use of biosimilars approved by the Food and Drug Administration (FDA) for ophthalmic indications. We recognize the societal value that biosimilars can play in improving care for eye disease.
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established to provide more treatment options, increase patient access and potentially lower health care costs. Manufacturing these molecules is complex. Biosimilars are not the same as generic drugs and are approved via a distinct pathway.
A biosimilar is identified by the four-letter suffix attached to the name to distinguish it from the innovator biologic. Newer innovator biologics also include a four-letter suffix, but ranibizumab, aflibercept and bevacizumab innovators do not. Since 2021, multiple biosimilars for ophthalmic biologics have received FDA approval.
The Academy supports the use of biosimilars approved by the FDA for ophthalmic indications.
- Biosimilars with this ophthalmology-specific approval can improve care for patients with eye disease.
- However, biosimilars to ophthalmic drugs that have not been approved for ophthalmic indications lack sufficient safety evidence for treatment of eye disease.
Insurers should not require ophthalmologists to use biosimilars that lack FDA approval for ophthalmic indications. The Academy also believes the choice of biologic product — innovator, biosimilar or interchangeable — should lie with the treating ophthalmologist and the patient.
What the Academy Is Doing
Since the first biosimilars approved for ophthalmic indications came onto the market, the Academy has provided ongoing education for member about the differences in treatment options and how to safely use them. The Academy has also challenged insurers who’ve required biosimilars not approved for ophthalmic indications in step therapy regimens. We have educated insurers on the important differences in how the FDA approves biosimilars.