U.S. Sees First Ophthalmologic Biosimilar Launch in Crowded, High-Cost Space

· 12 min read

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

The therapy is entering a crowded and high-cost space. According to Magellan Rx Management’s eleventh annual Medical Pharmacy Trend Report, released in May 2021 (the most recent version available), ophthalmic injections accounted for the second-highest category of spend in Medicare in 2019, behind only oncology. Besides Lucentis and Byooviz, other VEGF inhibitors, which are injected directly into the eye, include Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept), Novartis Pharmaceuticals Corp.’s Beovu (brolucizumab-dbll) and Genentech’s Susvimo, a version of ranibizumab for intravitreal use via an ocular implant, and Avastin (bevacizumab), which is used off-label in ophthalmologic indications. With its January approval, Genentech’s Vabysmo (faricimab-svoa) became the first bispecific antibody approved for the eye, blocking angiopoietin-2 (Ang-2) and VEGF-A.

“Eylea is the market-leading product, and bevacizumab continues to be a cost-effective VEGF inhibitor option used for ophthalmic conditions despite being used off-label,” says Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth. Compounded Avastin costs about $50 per injection compared with around $1,500 to $2,000 for the other treatments. “The market impact of Byooviz will likely be limited to movement from the Lucentis brand.”

According to Duygu Tanguler, head of global communications and corporate affairs for the biosimilars unit of Biogen International GmbH, “globally, approximately 170 million people are affected with AMD, and the prevalence of the advanced AMD is growing due to the aging population. The growing prevalence of retinal vascular disorders worldwide indicates that there is a genuine need for wider access to viable treatments.”

“Our research with physicians shows cost is cited as a leading barrier to patients initiating treatment, with one-third of patients unable to afford medication,” she tells AIS Health, a division of MMIT. “Byooviz has the potential to expand access to patients suffering from retinal disorders that can result in permanent vision loss, while also saving the U.S. health care system billions of dollars. We have seen in other therapeutic areas that the introduction of biosimilars leads to more people having access to treatment — often at an earlier stage of disease progression. That can make a tremendous difference to patients and” caregivers.

Ophthalmologists and patient organizations have expressed interest in information around access to treatment and coverage, Tanguler says. And while these stakeholders “have confidence in FDA-approved products,” biosimilars are new to the ophthalmologic space, and so “professional societies and patient organizations have wanted to know more about the standards for safety and efficacy that must be reached to receive approval.”

She points out, though, that “biosimilars were new to rheumatologists and oncologists five years ago. However, with the FDA's and industry’s educational efforts, we have seen the change in physicians’ awareness and attitudes toward biosimilars. Today, biosimilars are used widely in these areas, providing more affordable treatment options and expanding access to life-changing biologics.”

“Many of the ophthalmologists we have met have been very positive about the availability of a more affordable treatment option for patients living with retinal disorders,” says Tanguler. Because Byooviz is the first ophthalmologic biosimilar, “we are communicating with ophthalmology health care professionals and retina specialists to help them understand the science of biosimilars and the rigorous assessments required for FDA approval. We are offering a range of educational activities for ophthalmologists, including e-learning platforms, educational symposia at global congresses and publishing scientific manuscripts about biosimilars. As biosimilars become more widely used in real-world clinical practice, Biogen will be working closely with third-party investigators to generate real-world evidence on the clinical safety and effectiveness of biosimilars.”

Belazi says that “ophthalmologists will likely be willing to prescribe and utilize Byooviz as a therapy option for their patients who are candidates for ranibizumab therapy. The Phase III study compared Byooviz to the reference product, and the efficacy, pharmacokinetic and safety data showed comparable results.” That said, “potential barriers to adoption by ophthalmologists may include their familiarity and experience with the product, reimbursement and adoption by payers in their treatment pathways.” However, “for patients who may not have health insurance coverage, Byooviz may provide a lower cost option for ophthalmologists to prescribe for those patients who are not candidates for bevacizumab therapy.”

Another potential factor in Byooviz uptake is that it has approval for only three of Lucentis’ five FDA-approved indications: It was not approved for diabetic retinopathy (DR) and diabetic macular edema (DME). Tanguler explains that Byooviz is approved for wet AMD, RVO and mCNV as a single-use 0.5 mg (0.0 5mL of 10 mg/mL solution) vial, the same as Lucentis. For DME and DR, Lucentis is approved for a different dose: 0.3 mg (0.05 mL of 6 mg/mL solution). She points out, however, that in the European Union, Great Britain and Canada, Byooviz is approved for all five indications.

“The 40% lower cost of Byooviz as compared to Lucentis will greatly assist in gaining market share, but this will likely be from Lucentis and not from other VEGF inhibitor products,” Belazi says. “Other products may offer a more convenient dosing interval, which is attractive to both patients and ophthalmologists.”

Company Is Conducting Payer Outreach

Biogen also is reaching out to payers about the new biosimilar, and they have been “very receptive” to a more affordable option, says Tanguler. “Payers have had years of experience with biosimilars in immunology and oncology, and when we talked to payers about biosimilars for retinal patients in the U.S., they have been open to discussing biosimilars as one of the treatment options that will be considered along with other existing anti-VEGF agents.

“Many have been curious about conditions for coverage through Medicare,” she continues. “Retinal disorders are prevalent in elderly patients, and there is a higher percentage of patients covered by Medicare Part B or Medicare Advantage plans compared to other therapeutic areas. And currently there is a difference in reimbursement structure for ranibizumab between Medicare Part B versus Medicare Advantage and commercial plans. Because most Medicare Advantage and commercial plans require step edits through bevacizumab before moving on to ranibizumab or aflibercept, patients are slightly restricted from accessing these drugs, as step edit requires the patient to have failed on the first product. We hope that availability of Byooviz through formulary placement will allow patients to have better access to ranibizumab.”

“Payers will manage Byooviz similar to their current management of other biosimilar agents,” states Belazi. The new agent, he tells AIS Health, “will be a cost-effective alternative to Lucentis therapy and will be considered as an option in the therapeutic management of wet AMD patients. Since the product did not receive interchangeable status with Lucentis, Byooviz will be an additional therapy choice in the payer’s pathway for treatment, particularly when ranibizumab therapy is a preferred option for the patient. The recommended dosing intervals for the various VEGF inhibitors vary, and the dosing intervals are often customized for each patient, so direct cost comparisons can differ depending on the dosing frequency. Excluding the off-label use of bevacizumab, Byooviz provides one of the lowest annual drug costs of the currently available VEGF inhibitors based upon the labeled dosing frequencies.”

The company also is offering a variety of patient support services. “Biogen Biosimilar Support Services will offer benefits investigation to help research coverage options for patients, coverage and reimbursement support, insurance counseling for the uninsured and underinsured, and supplemental information for patients about Byooviz,” Tanguler explains, noting that health care providers will be patients’ primary source of information. Biogen also will offer drug copayment and administration copay assistance programs, as well as free drug programs for eligible patients.

Within the crowded ophthalmologic space, “payers typically use prior approval or prior authorization programs to ensure appropriate use of the VEGF therapies and utilize the ophthalmologists to help guide the correct treatment option for patients,” Belazi says. “Payers will try and drive the utilization to the most appropriate product for the patient while driving towards the clinically appropriate, cost-effective option. When there are multiple therapy options within a therapeutic class, payers will attempt to drive utilization to their chosen preferred drug products. Based upon the available clinical, efficacy and safety data and indications, payers will choose products that provide therapy options for their patients and providers.”

More biosimilars within the space are expected. According to the most recent version of AmerisourceBergen’s U.S. Biosimilar Report, updated May 27, approval for a Lucentis biosimilar from Coherus BioSciences, Inc. and Formycon AG is pending, and two more biosimilars are in Phase III. Eylea may soon face biosimilar competition as well, with six agents in Phase III and one awaiting FDA approval.

Biosimilars, asserts Tanguler, have the potential to broaden treatment access while lowering health care costs. She points to Biogen’s experience with tumor necrosis factor inhibitors in Europe, which she says has “shown Biogen’s ability to work with physicians and payers to encourage confidence and drive uptake of biosimilars, and we are very optimistic about bringing Byooviz to ophthalmologists and patients in the U.S.”

Contact Belazi through Caroline Chambers at cchambers@cpronline.com and Tanguler at duygulale.tanguler@biogen.com.

By Angela Maas

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