Product Profile:

Ranibizumab-nuna (Byooviz)

Drug Category: Inhibitor of vascular endothelial growth factor A (VEGF-A)

Target Indications: Treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV)

Developed by Samsung Bioepsis; the product will be marketed by Biogen

About the Manufacturer

Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen that operated as a subsidiary of Samsung Biologics Co., Ltd, until February 2022, when Biogen sold its stake in Samsung Biologics. In early 2013, Samsung Bioepsis and Merck entered into a business agreement to develop and commercialize biosimilars. Samsung Bioepis Co., Ltd. also entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Ltd in August 2017. The company was incorporated in 2012 and is based in Incheon, South Korea.

Other biosimilars from Samsung that have been approved by the FDA include infliximab (Renflexis®), trastuzumab (Ontruzant®), etanercept (Eticovo®), and adalimumab (Hadlima®). The latter two products have not yet been marketed in the US. In addition, Samsung Bioepis has several biosimilars in the late-stage pipeline, including versions of aflibercept, bevacizumab, denosumab, eculizumab, and ustekinumab.,

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Byooviz is the first biosimilar version of Lucentis to be approved, and other biosimilar competitors will be in play later in 2022. However, additional competition exists from the use of bevacizumab compounded by pharmacies and used for the same indication. This compounded product is priced far lower than that for Lucentis. Additionally, a manufactured form of bevacizumab specifically formulated for use as an intravitreal injection is awaiting FDA approval. Genentech, manufacturer of Lucentis, has introduced a port-administration system that allows for use of the reference product with fewer administrations.

Aflibercept, another intravitreally-administered drug used for the same indications, has a greater share of the market than Lucentis, and 6 biosimilars for this agent are due to be approved and launched before or by 2024.



Company Name Product Name Stage of Development
Bioeq IP/Formycon AG/Coherus FYB201/CHS-201 Filed for FDA approval in December 2019. Anticipating FDA approval in August 2022
Xbrane/Biopharma Stada Arzneimittel Xlucane Phase III trial estimated completion of December 2021. Plans were to submit to the FDA in 4th quarter 2021
Lupin LUBT010 Began phase III completion date estimated to be October 2022. An application is expected to be submitted to the FDA in Q1 2023, with a potential launch in early 2024

Biogen Sells Its Stake in Samsung Bioepis, Reaps Handsome Profit

(February 2, 2022) In 2019, Biogen upped its stake in the South Korean biosimilar joint venture, cementing its commitment to biosimilar manufacturing and commercialization. Today, however, Biogen has seemingly reversed course—though it is not exiting the biosimilar arena.

The Ranibizumab Port System: Issues for Patients, Payers, and Biosimilar Makers

(October 27, 2021) Susvimo is a follow-on to Lucentis®, an attempt to address one of the principal objections to ranibizumab treatment—monthly injections into the eye. However, Roche’s solution sounds only marginally more palatable: surgery (with a local anesthetic) to put an object into the eye that remains in place permanently. It is refilled with ranibizumab every six months. Clinical efficacy with Susvimo seems to be about the same as when receiving intravitreal injections.

Formycon and Bioeq Resubmit 351(k) Application

(August 10, 2021) On August 5th, partners Formycon AG and Bioeq AG announced that they had completed its new biosimilar ranibizumab application to the Food and Drug Administration, with an eye toward a mid-2022 decision. The US marketer of the product, if approved, will be Coherus Biosciences.

Samsung Bioepis and Biogen Register First FDA Approval for Biosimilar Ranibizumab

(November 18, 2020) On November 18, Samsung Bioepis and its marketing partner Biogen jointly announced that the 351(k) application for SB11, a ranibizumab biosimilar, has been filed and accepted by the Food and Drug Administration.

Samsung Bioepis’ Ranibizumab Biosimilar Application Filed With FDA

(November 18, 2020) On November 18, Samsung Bioepis and its marketing partner Biogen jointly announced that the 351(k) application for SB11, a ranibizumab biosimilar, has been filed and accepted by the Food and Drug Administration. The US patent for Roche’s reference product Lucentis® expired in June 2020, and the market for ranibizumab could be over $1 billion.

Who Are the Key Aflibercept Biosimilar Players to Watch?

(August 31, 2020) One of two biologics injected intravitreally to treat forms of macular degeneration, edema, or retinopathy, Eylea® (aflibercept) was first approved by the US Food and Drug Administration (FDA) on November 18, 2011. Originally approved as a single-dose vial, its manufacturer, Regeneron, received FDA approval of a prefilled syringe in December 2019. We covered the potential biosimilar competitors for the second product, Lucentis® (ranibizumab), in January 2020.

Who Are the Key Ranibizumab Biosimilar Players to Watch?

(January 16, 2020) Roche’s reference product Lucentis® (ranibizumab) seems to be the next likely target for biosimilar competition. Sales of the drug in the US were last reported to be $1.5 billion in 2017, but Roche’s revenues from Lucentis are expected to slip, owing to competition from Eylea® (aflibercept) primarily and some newer agents. And new Lucentis biosimilars will hasten that decline.

A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

(July 8, 2019) On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Ranibizumab in Diabetic Retinopathy

The Promise of Biosimilars

Clinical Trials of Byvooz

Byooviz was tested in one phase 3, double-blind trial for neovascular age-related macular degeneration.

Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference rabizumab product for patients with neovascular age-related macular degeneration

A total of 705 participants aged ≥50 years were enrolled in randomized, double-masked, parallel-group equivalence study for 48 weeks. Study eligibility was limited to patients with untreated subfoveal, choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye, with evidence of subretinal fluid, intraretinal fluid, retinal pigment epithelium detachment or leakage from CNV. Study participants received 0.5 mg of either the biosimilar ranibizumab SB11 (N=351) or reference product Lucentis (N=354) every four weeks for 48 weeks via intravitreous injection in the study eye. The non-study eye could receive treatment with the reference product ranibizumab with the results of these patients for antidrug antibodies and neutralizing antibodies excluded from the summary statistics.

The primary assessment was change from baseline in best-corrected visual acuity (BCVA) at week 8 and change in central subfield thickness (CST) at week 4. Visual acuity was measured using the early treatment diabetic retinopathy study charts, which is an equivalent to the Snellen test

Secondary endpoints included change from baseline in BCVA and CST at week 24, change in retinal lesion thickness (CRLT), and change from baseline in total CNV. Ocular adverse events were noted throughout the study as were immunogenicity parameters.

Similar changes were seen in both groups for the BCVA at week 8, least-squares mean of 6.2 ± 0.5 letters for the biosimilar group and 7.0 ± 0.5 letters in the reference product group. This was an adjusted treatment difference of –0.8 ± 0.62 letter (90% confidence interval [CI], –1.8 to 0.2 letters). The least-squares mean changes in CST at week 4 were –108 ± 5 µm in the biosimilar group and –100 ± 5 µm in the reference product group. The adjusted treatment difference was –8 µm (95% CI, –19 to 3 µm). Changes in the secondary endpoints were also similar.


Variable Byooviz

(N = 351)


(N = 353)

BVCA (letters) 8.6 ± 0.7 9.3 ± 0.6
CST (µm)* –136 ± 4 –126 ± 4
CRLT (µm) –148 ± 5 –139 ±5
CNV size (mm2) –4 ± 0 –4 ± 0

*N= 342 and 338 for the CST measurement


Based on the prespecified benchmarks of equivalent efficacy established by the investigators, they determined that the biosimilar’s clinical outcomes were not significantly different to those of the reference product.

Adverse events observed during the study were similar in both groups. Immunogenicity at 24 weeks was similar between the groups with 10 in each group (3.0% in the biosimilar group and 3.1% in the reference product group).

Variable Byooviz

(N = 350)


(N = 354)

Any Treatment-Emergent Adverse Event (TEAE)


231 (66.0%) 237 (66.9%)
Ocular TEAE in the study eye 97 (27.7%) 91 (25.7%)
Ocular TEAE in the non-study eye 69 (19.7%) 61 (17.2%)
Nonocular TEAE 178 (50.5%) 191 (54.0%)
Serious TEAE 44 (12.6%) 44 (12.4%)


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Patient Assistance Information
(This product is not yet available for prescription)

US Biosimilar Filings Status

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