Use of Biosimilars
June 14, 2023
Dear Colleagues:
Recently OMIC Risk Management has received a number of inquiries regarding the use of biosimilar medications for ophthalmic care. We would like to clarify our position on this topic.
1. Bevacizumab (Avastin®) biosimilars
There is limited intraocular experience with bevacizumab biosimilars because studies leading to their FDA approval were for systemic usage for the treatment of cancer.
For this reason, the AAO and CMS issued statements that bevacizumab biosimilars should not be used in the eye; OMIC is aligned with these statements.
AAO statement 2022 https://www.aao.org/education/clinical-statement/use-of-biosimilars-in-ophthalmic-practice
2. Ranibizumab (Lucentis®) biosimilars
There is much more experience with ranibizumab biosimilars because the FDA tested them specifically for retinal diseases such as age-related macular degeneration, diabetic macular edema, and vascular occlusions. The FDA has approved ranibizumab biosimilar drugs for most of those indications, and has designated one compound as interchangeable with Lucentis®. There are health insurance carriers that have step policies in place that require ophthalmologists to use a ranibizumab biosimilar before using the brand name drug.
OMIC concurs with the AAO’s position that these drugs can be used, and the provider should be aware that the experience with these compounds is not as extensive as the brand name drug.
3. Biosimilars for treatment of Retinopathy of Prematurity (ROP)
a. Bevacizumab (Avastin®) biosimilars
OMIC’s position is that they should not be used to treat ROP at this time.
b. Ranibizumab (Lucentis®) biosimilars: These are FDA-approved drugs for the treatment of multiple retinal diseases. The experience with these compounds for the off-label treatment for ROP is limited, with recent small series studies showing potential efficacy.
OMIC’s position is that they should not be used to treat ROP at this time until further trial results become available.
If you have questions regarding this information, please contact us. Remember that you may contact the Risk Management Hotline for confidential assistance at riskmanagement@omic.com or call the Risk Management Hotline at 1-800-562-6642 and choose option 4.
Sincerely,
Michael C. Tigani, MD
Chair, OMIC Risk Management Committee
