Latest FDA biosimilar approvals ushering in more treatment options

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The availability of biosimilar products is driving the addition of new treatment options in ophthalmology as demonstrated by the recent news of the FDA’s approval of Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, both close copies of Regeneron Pharmaceutical’s Eylea.

According to a news release, the FDA described the products as “interchangeable biosimilars,” suitable for treating patients with neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion, diabetic macular edema, and/or diabetic retinopathy.¹

The approval gives ophthalmologists and patients additional therapeutic options, according to George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology.

“In 2023 the FDA announced that all biosimilars are interchangeable with the respective reference products confirming that there are no clinically meaningful differences between the biosimilar and the reference product,” Williams said in a statement provided to Ophthalmology Times. “The primary drivers of biosimilar development are to improve patient access, increase treatment options and perhaps most importantly decrease drug costs for patients and the health care system. To date, the cost savings for ranibizumab biosimilars have been limited.”

Ultimately, Williams noted, the potential effect of aflibercept biosimilars on cost savings will depend on pricing. He added that a probable significant impact of aflibercept biosimilars will involve step therapy.

“How these biosimilars will be incorporated into step therapy protocols remains to be determined and is likely to vary across commercial and government payers,” Williams added. “This will contribute to the increasing administrative burden of providing retinal drug therapy. Once the biosimilars are available, ophthalmologists’ initial clinical experience with biosimilars will be an important determinant of uptake.”

Ian C. Han, MD, director of Retina Service, and an associate professor at the Institute for Vision Research, Department of Ophthalmology and Visual Sciences at University of Iowa Hospital and Clinics, and a member of the Ophthalmology Times Editorial Advisory Board, agreed that the FDA approval of biosimilars to aflibercept/Eylea add to the already substantial and growing armamentarium of intravitreal anti-vascular endothelial growth factor (VEGF) agents to treat common retinal diseases.

“Eylea is a frequently used medication that has been FDA-approved since 2012 and has a long track record of safety and efficacy; the availability of Eylea biosimilars provide broader options for treatment for retina specialists and their patients,” he said.

Sharon Fekrat, MD, a retinal surgeon, director of the Duke Vitreoretinal Surgery Fellowship Program, and member of the Ophthalmology Times Editorial Advisory Board, said the approval may lead to too many options.

“There are too many relatively expensive options now, including biosimilars, and it is possible as a result, pharmacies may choose to limit those anti-VEGF options that they will stock which in turn limits the options we have available for our patients,” Fekrat said.

The biosimilars landscape also could be impacted by the number of options available.

“The paradox of choice now exists with too many choices and options that are overall relatively similar, give or take relatively small differences (ie maybe better drying, or better durability) - clinical trial findings do not always match up to real-world outcomes,” she said.

Fekrat also noted that while retina specialists are highly skilled and knowledgeable to make anti-VEGF choices for their patients and for which patients seek their expertise, “insurance companies continue to dictate step therapy with regard to pharmacotherapy choice and slow down the timing of treatment initiation and sometimes continuation with prior authorization requirements which may ultimately affect patient outcomes negatively. “

Fekrat added that ophthalmologists should consider interchangeable biosimilars as a way to save money for patients who have significant out-of-pocket costs. But with insurance companies dictating step therapy, she said it is taking away the clinical judgment by retinal specialists.

“So even though the availability of biosimilars may indeed shift the paradigm, the choice may not be ours,” she said.

Moreover, Han pointed out that biosimilars can be considered as interchangeable with the primary drug, providing potential benefits for patients and the overall health care system in reducing cost burdens.

“A common situation to consider biosimilars is when a patient's insurance requires step therapy, or the patient has limited ability to pay for other commercial drug options,” he said. “The safety and efficacy of these medications meets FDA guidelines through streamlined approval pathways, but individual patient responses to treatment, including with regard to safety (e.g., inflammation), still need to be carefully monitored by the treating physicians when translating these results to everyday practice. “

From a practical standpoint, Han explained that biosimilars add to the availability of treatment, but also the complexity of daily retina practice.

“For example, the growing number of available treatment options increases complexity in decision-making, switching drugs for existing patients can be time-consuming to discuss, there are often logistical challenges to maintaining multiple drugs on formulary, and navigating insurance requirements such as step therapy can be tedious,” he noted.

Han added that biosimilar drug development, approval and implementation within ophthalmology is currently in its relative early days.

“Prior biosimilars (eg, ranibizumab biosimilars) have had variable uptake in practice, in part due to some of the practical barriers as outlined above,” he explained. “In theory, biosimilars may expand the ability to treat some patients, broadening the scope of anti-VEGF therapy, but the pragmatic barriers sometimes limit uptake in the absence of other benefits (e.g., superior drug effect, longer duration, broader indications) to offset the time and logistical costs. “

More about the approval

In a news release, Biocon noted its aflibercept-jbvf (Yesafili) is a VEGF inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product aflibercept.²

The company noted in its news release that aflibercept-jbvf is intended for the treatment of nAMD, visual impairment due to macular edema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema and visual impairment due to myopic choroidal neovascularization. Biocon also noted in its news release it is “highly similar to the reference product Eylea (aflibercept)” with data demonstrating it has “comparable quality, safety, and efficacy to Eylea.”

Shreehas Tambe, CEO and managing director, Biocon Biologics, said the FDA approval marks the company’s entry into ophthalmology, a new therapeutic area for the company in the United States.

“Yesafili is approved for the treatment of neovascular [AMD], macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy,” Tamble said in the company’s news release.

The company also said the approval builds upon its record of bringing biosimilars to the market, such as the first interchangeable insulin, Semglee, the first biosimilar Trastuzumab, Ogivri, and the first biosimilar pegfilgrastim, Fulphila, to patients in the United States.

Samsung Bioepis and Biogen did not respond to Ophthalmology Times’ request for comment, but in the company’s Q2 2024 US Biosimilar Market Report released last month, Thomas Newcomer, vice president, Head of Market Access, US, at Samsung Bioepis, reiterated the company’s commitment to its work in biosimilars.³

“As we move forward, Samsung Bioepis remains committed to delivering high-quality, safe, and effective biosimilars,” he said in the report. “Our goal is to be part of the solution in reducing patients' out-of-pocket expenses, while offering savings to the US healthcare system as a whole.”

While there currently is no date for these therapeutics to hit the US market, Biocon announced in March that it will launchaflibercept-jbvf in Canada no later than July 1, 2025. The company also received marketing authorization approval in the UK for aflibercept-jbvf in November 2023.

References

1. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. US Food & Drug Administration. May 20, 2024. Accessed May 21, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye

2. Ltd BB. Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for YesafiliTM. Enters U.S. Ophthalmology Market. www.prnewswire.com. Accessed May 21, 2024. https://www.prnewswire.com/news-releases/biocon-biologics-obtains-us-fda-approval-for-biosimilar-aflibercept-for-yesafili-enters-us-ophthalmology-market-302150830.html

3. SAMSUNG BIOEPIS. www.samsungbioepis.com. Accessed May 21, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=386&currentPage=1