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Achromatopsia: Understanding the rare inherited retinal disease

The Food and Drug Administration (FDA) announced its approval of 2 biosimilars as interchangeable with aflibercept 2 mg (Eylea).

The agency approved aflibercept-jbvf (Yesafili, Biocon Biologics) and aflibercept-yszy (Opuviz, Samsung Bioepis, Biogen). All 3 products are anti-vascular endothelial growth factor (VEGF) agents, administered intravitreally for neovascular age-related macular degeneration (nAMD). Aflibercept-jbvf and aflibercept-yszy are the first interchangeable biosimilars to aflibercept 2 mg.

In a news release, the FDA described the products as “interchangeable biosimilars,” suitable for treating patients with nAMD, macular edema following retinal vein occlusion, diabetic macular edema, and/or diabetic retinopathy. The news release went on to detail the safety profile for aflibercept-jbvf and aflibercept-yszy. 

“The side effects and adverse events observed in clinical studies of Yesafili and Opuviz are consistent with those observed with Eylea,” the agency wrote.

 “The most common (≥5%) of these side effects included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.”

Following the FDA approval of aflibercept 8 mg (EYLEA HD) in August 2023, Regeneron has placed a focus on the higher-dose product, recording $200 million in sales in the first quarter of 2024.

Aflibercept 8 mg also received EU marketing authorization from the European Commission in January of this year.

 Biocon Biologics Limited received marketing authorization approval in the UK for aflibercept-jbvf in November 2023.

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

US FDA approves two biosimilars for blockbuster eye drug Eylea. Reuters. May 20, 2024. Accessed May 21, 2024. 

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-biocon-units-biosimilar-blockbuster-eye-drug-eylea-2024-05-20/

Hayes H. European Commission grants EU marketing authorisation for aflibercept (Eylea) 8 mg. Ophthalmology Times Europe. January 8, 2024. Accessed May 21, 2024. 

https://europe.ophthalmologytimes.com/view/european-commission-grants-eu-marketing-authorisation-for-aflibercept-eylea-8-mg

The agency approved Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis, Biogen) as biosimilars to Eylea (Regeneron Pharmaceuticals).

clinical

US FDA issues approval for two aflibercept biosimilars 

The US Food and Drug Administration (FDA) has approved biosimilar to Eylea, aflibercept-mrbb (Ahzantive), for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD).

The biosimilar has also been approved for treatment in patients with serious retinal diseases such as diabetic macular edema (DME), diabetic retinopathy (DR) and macular edema following retinal vein occlusion (RVO).

2 other aflibercept biosimilars were recently approved by the FDA

, Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis Opuviz (aflibercept-yszy).

The news was announced in a press release from biosimilar developer Formycon AG and its licensing partner Klinge Biopharma.

 CEO Stefan Glombitza, PhD, stated that the FDA approval of Ahzantive was “another key milestone on [their] way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of [their] team.” He further stated that alongside the approved Lucentisbiosimilar FYB201, he believes the company has an “outstanding position in ophthalmic biosimilar therapies.”

According to the company, the active ingredient in Ahzantive inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

Furthermore, the company stated that FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that Ahzantive demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eyleain patients with nAMD.

In addition to the FDA approval, the company also submitted a marketing authorization application with the European Medicines Agency (EMA) and expects a response by early 2025.

Formycon Receives FDA Approval for FYB203/AHZANTIVE (AFLIBERCEPT-MRBB), a biosimilar to Eylea. Press Release; July 1, 2024. Accessed July 2, 2024. 

https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/

The biosimilar was approved for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive) 

Altos Biologics Inc. has submitted the Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept biosimilar. This biosimilar was developed by Alteogen. Altos Biologics Inc. is a subsidiary of Alteogen.

According to the company’s press release

, the phase 3 clinical trial for ALT-L9 began with initial clinical trial approval in 2022 and incorporated over 400 participants from 12 countries, including those in Europe, South Korea, and Japan. The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet age-related macular degeneration (wet AMD). The primary endpoint of the study was change in best-corrected visual acuity (BCVA) over 8 weeks.

Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics, shared the further plans for this biosimilar in the release

, saying, "Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea."

Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide.

1. Altos Biologics Files Approval of Aflibercept Biosimilar. Alteogen Inc. Published July 1, 2024. Accessed July 2, 2024. https://www.morningstar.com/news/pr-newswire/20240701cn52238/altos-biologics-files-approval-of-aflibercept-biosimilar

The company expects approval from the EMA by 2025. 

Altos Biologics submits Marketing Authorization Application to the EMA for ALT-L9, an aflibercept biosimilar

Lupin has successfully completed a global, phase 3 clinical study of LUBT010. This candidate is a ranibizumab biosimilar to Lucentis. The study achieved its primary endpoint, which was equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis.

Since 2022, Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes. Ranibizumab is used in the treatment of wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

, Lupin noted that the Phase 3 study was designed as a global clinical trial, in line with recommendations from European Medicines Agency (EMA) and FDA in the United States. The trial was designed to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with wet AMD. A total of 600 patients from locations in India, US, EU, and Russia were randomized in the study, who received either LUBT010 or Lucentis 0.5 mg. Both treatments were administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety, and immunogenicity assessment.

Dr. Cyrus Karkaria, President of Lupin Biotech, commented on this milestone and next steps in the company's press release

, saying, “We are very pleased with the positive outcome of the global Phase 3 study, which marks yet another significant developmental milestone for our Lucentis biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs. We will be filing marketing applications for LUBT010 in all major global markets this year.”

Similarly, Nilesh Gupta, Managing Director of Lupin noted the potential impact on patients this biosimilar may have, saying, “This achievement of our Biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab Biosimilar into the global Ophthalmic market, making a positive difference in the lives of our patients worldwide.”

The data gathered during this Phase 3 study will be part of Lupin’s application for marketing approval with the FDA and the EMA.

1. Lupin Announces Successful Completion of Phase 3 Trials for Lucentis® Biosimilar. Global Pharma major Lupin Limited. August 5, 2024. Accessed August 5, 2024. https://www.lupin.com/lupin-announces-successful-completion-of-phase-3-trials-for-lucentis-biosimilar/

LUBT010 is a ranibizumab biosimilar to Lucentis that achieved its primary endpoint in this study.

Lupin's phase 3 trials for ranibizumab biosimilar reaches primary endpoint

On Friday, September 20, 2024, Samsung Bioepis Co., Ltd., based in Korea, and Biogen Inc, based in Massachusetts, announced the European Medicines Agency (EMA) issued a positive opinion for SB15 40mg/mL (OPUVIZ). The Committee for Medicinal Products for Human Use (CHMP) issued its recommendation for marketing authorisation, which will be referred to the European Commission for approval. The CHMP’s positive opinion was based on a totality of evidence surrounding SB15, including both clinical and non-clinical data, according to a press release.

According to Samsung Bioepis and Biogen, SB15 has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration, visual impairment due to macular oedema secondary to branch or central retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularization.

A randomised, double-masked, parallel group, multicentre Phase 3 study demonstrated equivalent efficacy, as well as comparable safety, immunogenicity and phamacokinetics between SB15 and the reference product, aflibercept. These results were assessed at weei 8, the 32-week interim period and at 56 weeks.

This is the companies' second ophthalmology biosimilar to receive the recommendation. SB11 (BYOOVIZ, biosimilar ranibizumab), was awarded marketing authorisation in 2021. Samsung Bioepis and Biogen announced a commercialisation for two biosimilar candidates, SB11 and SB15, in November 2019.

Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, called the CHMP opinion a significant milestone. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies,” she said. “We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology.”

The European Commission will decide whether to grant the marketing authorisation for SB15 following the CHMP's ruling.

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ. Press release. Biogen. Published 20 September, 2024. Accessed 20 September, 2024. 

https://investors.biogen.com/news-releases/news-release-details/samsung-bioepis-and-biogen-receive-positive-chmp-opinion-0

The CHMP will recommend SB15, biosimilar to aflibercept (Eylea), for marketing authorisation by the European Commission

Canonical

EMA announces positive opinion for SB15 (OPUVIZ, Samsung Bioepis and Biogen)

Sandoz announced it has received FDA approval for aflibercept-abzv (Enzeevu) 2 mg vial kit and pre-filled syringe for intravitreal injection.

According to a news release, aflibercept-abzv is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).

The FDA also provisionally stated aflibercept-abzv would be interchangeable with the reference therapeutic as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Claire D’Abreu-Hayling, chief scientific officer of Sandoz, lauded the announcement and noted that nAMD continues to be a leading cause of vision impairment in patients over 50 years in North America.

“This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision,” D’Abreu-Hayling said in a news release. “The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”

According to the news release, the FDA approval of aflibercept-abzv will advance the company’s growth strategy by further extending its US ophthalmology portfolio. The launch of aflibercept-abzv will depend on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements.

Jeff Todd, president and CEO of Prevent Blindness, welcomed news of the FDA approval.

“As sight disappears, so may a person’s connection to the world,” Todd said. “We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer.”

Todd pointed out there currently is no cure for the disease and long-term treatment can be costly.

“Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable,” he said.

The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study (NCT04864834), an international, multicenter, randomly assigned, double-masked, 2-arm parallel study in 485 patients with nAMD with a duration of 52 weeks. It confirmed equivalent efficacy and comparable safety and immunogenicity for aflibercept-abzv and the reference medicine Eylea.

This approval comes in the wake of the ranibizumab-eqrn (Cimerli) business by Sandoz in the United States earlier in 2024.

Sandoz.com. Published 2024. Accessed August 12, 2024. https://www.sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/

According to the company, the FDA approval strengthens its biosimilar position in the US market. 

Christine N. Kay, MD

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