Biosimilars in Ophthalmologic Practice

The Academy supports the use of biosimilars approved by the Food and Drug Administration (FDA) for ophthalmic indications, and we recognize the societal value biosimilars can play in improving care for patients with eye disease.

Our position is guided by two key principles:

• Biosimilars with ophthalmology-specific FDA approval can improve care for patients with eye disease.
• Biosimilars to ophthalmic drugs that have not been approved for ophthalmic indications lack sufficient safety evidence for the 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.

Since the first biosimilars approved for ophthalmic indications came onto the market, the Academy has provided ongoing education to members about the differences in available treatment options and how to use them safely.

The Academy has also challenged insurers who have required biosimilars not FDA-approved for ophthalmic indications in step therapy regimens, and has educated insurers on the important distinctions in how the FDA approves biosimilars versus other biologics.

The Biologics Price Competition and Innovation Act of 2009 created an abbreviated FDA approval pathway for biological products demonstrated to be biosimilar to or interchangeable with an already-approved biological product. This pathway was established to expand treatment options, increase patient access, and potentially lower health care costs.

Biosimilars are not the same as generic drugs. Manufacturing these complex molecules requires a distinct approval pathway, and biosimilarity does not automatically confer equivalence across all indications of the reference biologic.

A biosimilar is identified by a four-letter suffix attached to its name to distinguish it from the innovator biologic. Newer innovator biologics also include a four-letter suffix; however, the innovator forms of ranibizumab, aflibercept, and bevacizumab do not. Since 2021, multiple biosimilars for ophthalmic biologics have received FDA approval.

Know the terms:

• Biologics are complex medicines made from living cells or organisms, such as proteins, tissues, or genetic material. They are used to treat a wide range of diseases, including many chronic and serious conditions.
• Biosimilars are biologic medicines that are highly similar to an FDA-approved biologic (called a reference product). They have no clinically meaningful differences in safety or effectiveness and provide comparable treatment outcomes.