WHO WE ARE
The California Academy of Eye Physicians and Surgeons (CAEPS) is the only statewide organization representing California ophthalmologists and their patients. CAEPS' activities include public education about important eye health care concerns, legislative advocacy, interaction with third party payers about reimbursement and coverage issues, and continuing medical education for ophthalmologists and their staffs.
NOT A MEMBER? JOIN US
If you are a California ophthalmologist, be part of an organization working for California ophthalmology!
CAEPS is Here for YOU.
- CAEPS Saves You Money
- CAEPS Fight Policies that Hurt Your Practice and Patients
- Joining AAO and CMA are NOT Enough
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BIOSIMILARS OFFER ADDITIONAL TREATMENT OPTIONS
According to the US Food and Drug Administration (FDA), "A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product."
Clinically "inactive" components -- such as stabilizers or buffers (chemicals that the biologic product is dissolved or suspended in, for example) are allowed to be different in the products as long as safety and efficacy are not impacted.The FDA also indicates an "interchangeable" product is "expected to produce the same clinical result as the [biologic it is "similar" to] in any given patient," allowing it it to be "substituted for the reference product without the involvement of the prescriber.
The American Academy of Ophthalmology (AAO) has issued a statement regarding biosimilars for use in the treatment of eye disease. According to the AAO, and CAEPS concurs,
"Before a biosimilar is required to be used for treatment or included in a step therapy regimen, it should be FDA-approved for the [specific eye purpose]. Such a pathway ensures there is evidence of safety—including for any [inactive components] — and efficacy for its use in the eye." Short of that, "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."
Patients are advised to discuss fully the risks and benefits of any treatment option so they can make an informed decision about their care.