Retinal Physicians Report Reservations Around Ophthalmology Biosimilars

There are already 2 ranibizumab biosimilars approved in the United States and 3 in Europe, with additional ophthalmology biosimilars on the horizon, but just slightly more than half of physicians who participated in the Biosimilars for Retinal Diseases- United States-Europe Awareness Survey (Bio-USER survey) reported being familiar with anti–vascular endothelial growth factor (VEGF) biosimilars.

The results of the survey were published in Expert Opinion on Biological Therapy. The purpose of the Bio-USER survey was to understand awareness of biosimilar anti-VEGF agents.

“Patients often turn to health care professionals as a source of information related to newer medicines. Hence, it is important to understand the awareness regarding these molecules amongst clinicians,” the authors explained. “Only when clinicians are well acquainted with biosimilars can they effectively counsel patients.”

A 16-question survey was sent via email, WhatsApp, and LinkedIn to retinal physicians in the United States and Europe between December 1, 2021, and January 31, 2022. There were 112 respondents (55 from the United States and 57 from Europe). The majority respondents were male (69.6%) and had an academic faculty position (64.2%). The mean age of respondents was 44.7 years.

More than half (56.3%) said they were familiar with anti-VEGF biosimilars, but only 35.7% admitted to having a complete understanding of them. Additionally, 23.2% said there was a need for more information regarding using a biosimilar vs the originator drug.

Less than half (45.5%) were aware of the recently FDA- and European Medicines Agency–approved ranibizumab biosimilar. When the survey began, Byooviz from Samsung Bioepis had been recently approved. It received EU marketing authorization in August 2021 and was approved by the FDA in September 2021. Byooviz launched in the United States in June 2022.

After the survey was concluded, Cimerli from Coherus Biosciences was approved (August 2022) and launched in the United States (October 2022), Ranivisio from Teva Pharmaceuticals and Bioeq received EU marketing authorization (August 2022), and Ximluci from STADA Arzneimittel and Xbrane Biopharma received EU marketing authorization (September 2022).

Regarding safety and efficacy:

• 64.2% said they wanted more information about the safety, efficacy, and performance of anti-VEGF biosimilars in order to better understand them.
• 69.6% said biosimilar anti-VEGFs were similar in efficacy, safety, and purity compared with the originator product
• 16% believed biosimilars were less safe than the originator
• 8.9% said they did not know about the safety and efficacy compared with the originator
• 5.3% thought biosimilars were not as efficacious

Nearly all (91%) the respondents agreed lower pricing was a major advantage of using biosimilars over the reference product. However, only 15.2% responded that they would initiate treatment with a ranibizumab biosimilar if it was a lower cost. At the time of the survey, the pricing of biosimilar ranibizumab had not been disclosed. Slightly more than one-third (34.4%) were in favor of switching patients already on treatment while 11.6% said they were not in favor of switching and 36.6% wanted more information before making the switch.

Less than one-third were willing to switch to a lower-cost ranibizumab biosimilar from off-label bevacizumab, which is used commonly in ophthalmology, although not approved for any ophthalmic indications. The survey did find that European physicians were more in favor of switching from off-label bevacizumab to an approved, lower-cost ranibizumab biosimilar compared with US physicians.

The authors noted that the small sample size and the different ways health care systems are organized and financed across Europe limits the generalizability of these findings as the responses might not present the view of all retina specialists.

“With the availability of 2 FDA and EMA ranibizumab biosimilars and a strong pipeline of biosimilars (ranibizumab and aflibercept) for the management of retinal diseases, this survey highlights the need for better and more comprehensive sources of information on these therapeutic alternatives specifically to mitigate the concerns on safety and efficacy of biosimilars among retina physicians in the United States and Europe,” the authors concluded.

Reference

Sharma A, Holz FG, Regillo CD, et al. Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey). Expert Opin Biol Ther. Published online February 1, 2023. doi:10.1080/14712598.2023.2176218