Delving into the Latest Updates on AFLIBERCEPT-JBVF with Synapse

Overview

Basic Info

Drug Type

Fc fusion protein, Biosimilar

Synonyms

Aflibercept Biosimilar (Viatris, Inc.), 阿柏西普生物类似药（Viatris, Inc.）, M710

+ [2]

Target

PGF x VEGF-A

Action

inhibitors

Mechanism

PGF inhibitors(Placental Growth Factor inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [3]

Active Indication

Vision, LowDiabetic RetinopathyDiabetic macular oedema+ [3]

Inactive Indication-

Originator Organization

Viatris, Inc.

Active Organization

Biocon Biologics Ireland Ltd.Biocon Biologics, Inc.

Biocon Biologics Ltd. (India)

Inactive Organization

Momenta Pharmaceuticals, Inc.Mylan Pharmaceuticals, Inc.

License Organization

Biocon Ltd.

Mylan NV

Momenta Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

European Union (15 Sep 2023),

Diabetic macular oedemaMyopic choroidal neovascularizationRetinal vein occlusion-related macular edema+ [1]

Regulation-

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Structure/Sequence

Sequence Code 4715606

The sequence is quoted from: *****

This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021.

Interventions:

Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52.

Main Outcomes and Measures:

The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of −3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs).

Results:

A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, −1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was −112 (7) μm vs −124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, −3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms.

Conclusions and Relevance:

MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03610646

01 Feb 1989·Scandinavian journal of immunologyQ4 · MEDICINE

Reduced Erythrocyte CR1 (CD 35) Receptor Function and Complement Opsonization in Factor I‐Deficient Patients is Restored by Plasma Infusion

Q4 · MEDICINE

Article

Author: H. H. JEPSEN ; J. M. RASMUSSEN ; B. TEISNER ; S.‐E. SVEHAG

Erythrocytes (E) from three factor I‐deficient patients were investigated for surface‐bound complement factors and CR1 (CD 35) expression and function. The E were coated with C4b,C3b, and factor H. Following plasma infusion of in vitro incubation of the patients’ E with normal human serum (NHS) or purified factor I, cell‐bound C4b and C3b could no longer be detected. The E now expressed C3d, and factor H was unaffected, indicating that factor H was hound to the C3d part of the C3b molecules, providing the co‐factor for effective cleavage of E‐bound C3b when purified factor 1 was added. The binding of monoclonal anti‐CR1 antibodies (M710) to the patients’ E was markedly reduced compared with control E, and was not normalized by treatment with NHS, probably because covalently bound C3d/factor H interfered with the binding of M710. By contrast, the reduced ability of the patients’ E‐CR1 to bind complement‐opsonized immune complexes (IC) was normalized after plasma infusion. This shows that the impaired CR1 function was acquired and emphasizes the importance of performing functional CR1 assays. Complement opsonization of IC for binding to normal E was severely compromised in the patients’ sera due to consumption of factor B and C3. After plasma infusion the opsonization capacity of the patients’ sera was restored. Thus, two mechanisms of importance for normal clearance of IC were compromised in factor I‐deficient patients: (1) the opsonization of IC for binding to E‐CRI, and (2) the capacity of E‐CRI to bind opsonized complexes. Both dysfunctions were temporarily corrected by plasma infusion.

01 Jan 1986·Journal of immunopharmacology

Complement Receptors (CR) and Cytotoxic Responses: Monoclonal Antibodies Directed Against CR1 AMD CR3 Inhibit the Generation of Human Allospecific and Virus Specific Cytotoxic Cells in Vitro

Article

Author: Giorgio Inghirami ; George C. Tsokos ; John D. Lambris

A variety of cellular immune responses involve complement factors which bind to specific receptors, and modulate or effect a specific reaction. Monoclonal antibodies (MAb) have been generated against complement receptors (CR) 1 and 3, which were utilized to investigate human allogeneic and Epstein-Barr virus specific cytotoxic cells in vitro. MAb OKM1, which binds to the C3bi CR (CR3), and MAb M710, which binds to the C3b/4b CR (CR1), inhibited the generation of both allogeneic and virus specific cytotoxic responses in vitro in a dose-dependent way; doses of 1 microgram/ml (or greater) completely abrogated the cytotoxic responses. Inhibition of these responses was observed when the MAb was added to the cultures at any time point except the last two days. In addition, treatment of the responder (but not the stimulator cells) with either MAb resulted in complete inhibition of cytotoxic responses. These experiment indicate that complement receptors participate in the generation of human cytotoxic responses in vitro.

35

News (Medical) associated with AFLIBERCEPT-JBVF

21 Nov 2025

·pharma.economictimes.indiatimes.com

Biocon in very unique position globally as a biosimilars leader: Kiran Mazumdar-Shaw

Mumbai: Biocon is entering a transformative phase in its journey as a global biosimilars leader driven by regulatory shifts in the US, strategic partnerships and a robust insulin and GLP-1 portfolio, executive chairperson Kiran Mazumdar-Shaw said. The company is uniquely positioned to accelerate growth, reduce financial burden and expand its footprint in the high-value biologics space, Shaw told ET in an exclusive interview. "We are in a sweet spot and a very unique position," Shaw said. "Nobody else has interchangeable insulins and insulin now is becoming a very big opportunity for Biocon Biologics because of the fact that the actual insulin companies are planning to focus on GLP-1s. We are taking that advantage globally." Biocon is the only company with interchangeable biosimilar insulin analogues like insulin glargine (Semglee) and insulin aspart (Kirsty) in the US market. According to Shaw, the company's acquisition of Viatris' global portfolio of biosimilars, often scrutinised for its debt impact, has strengthened Biocon 's position as one of the top five biosimilars companies globally. Biocon Biologics acquired Viatris' global biosimilars business in 2022 for $3.3 billion and has been trying to cut acquisition-related debt of $1.2 billion. "People focus too much on the acquisition debt and not enough on the fact that we have become a leading global biosimilars company," said Mazumdar-Shaw. Referring to the company's R&D priorities in new therapeutic areas such as GLP-1 analogues , Mazumdar-Shaw said: "We have done this successfully for insulins and for liraglutide and are confident that semaglutide will be quite straightforward for us." According to Shaw, the recent draft guidelines by the USFDA, which propose to waive off the requirement for phase-III clinical trials for certain biosimilars that demonstrate robust chemistry, manufacturing and controls (CMC) package, presents a significant opportunity for Biocon . The USFDA's new draft guidance eliminates the need for most comparative efficacy trials-the costliest and slowest step in biosimilar development. Instead, it will allow developers to rely on advanced analytical and functional testing to demonstrate similarity with reference biologics. The agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. "Once we get the first approval without phase-III trials, it will set the stage for more launches and significantly reduce our R&D costs." It will allow the company to do more for the same amount of R&D spend, creating a compelling advantage over competitors, according to Mazumdar-Shaw. Biocon has already delivered an array of biosimilars over the past 12-18 months, including ustekinumab (Yesintek, used to treat chronic autoimmune condition), aflibercept (Yesafili, used for treatment of certain eye conditions), insulin aspart (Kirsty), bevacizumab (Jobevne, a cancer drug), and recently denosumab (Bosaya and Aukelso indicated for osteoporosis and cancer-related bone). The company has also reached a settlement with Amgen for denosumab, enabling its upcoming US launch. With these approvals, Biocon is in the "acceleration" phase, having built a diversified portfolio that few competitors, including Sandoz, Amgen, Pfizer , Celltrion, or Samsung, can match in scale and vertical integration, said Mazumdar-Shaw. "We have a large basket of biosimilars now in the market and nobody else has this scale of products," she said. Biocon's cancer drugs Fulphila (pegfilgrastim) and Ogivri (trastuzumab) have over 25% US market share. "The kind of growth story we are creating is going to be exciting in the immediate five-year window and beyond," said Mazumdar-Shaw. "After 2030, there will be some very exciting products becoming big-ticket opportunities for companies like us, more cancer drugs PD-1s and many other products." The insulin and GLP-1 segments are emerging as high-growth adjacencies for Biocon. Shaw emphasised that the company's deep experience in insulin manufacturing and patient familiarity with Biocon devices provide a natural advantage in GLP-1 analogues , so introducing GLP-1 is seamless. By Rica Bhattacharyya ,

AcquisitionLicense out/inDrug Approval

22 Oct 2025

·www.fiercepharma.com

Regeneron settles Eylea patent dispute with Celltrion, allowing another biosimilar to launch at end of 2026

Regeneron's agreement with Celltrion follows recent settlements with other Eylea biosimilar makers including Sandoz and Biocon Biologics. Regeneron has settled its patent dispute with Celltrion, giving the go-ahead for another biosimilar to its blockbuster eye drug Eylea (aflibercept) to hit the U.S. market in just over a year.The deal settles all patent litigation between the two companies and allows Celltrion to launch its biosimilar on Dec. 31, 2026, Regeneron said in an Oct. 20 statement. Other terms of the agreement, including financial considerations, remain confidential.South Korean drugmaker Celltrion won U.S. approval for its biosimilar on Oct. 9, with the FDA signing off on the drug's use in the same indications Eylea holds for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. The Eylea biosim will be marketed under the name Eydenzelt. In trials, the drug “met the predefined equivalence criteria” to Eylea and showed similar results to the reference product in secondary endpoints of efficacy, safety and immunogenicity, according to Celltrion. Celltrion is the latest to win an FDA nod for its aflibercept product out of the biosim developers Regeneron has sued. Celltrion, Sandoz, Amgen, Formycon, Samsung Bioepis and Mylan Pharmaceuticals—plus partner Biocon Biologics—have all been the subjects of Regeneron’s attempts to block out the biosimilar competition in the courts.Only Amgen, however, has emerged with a legal victory over Regeneron, enabling the company to sell the only marketed Eylea biosimilar in the U.S. But, with Regeneron's recent settlements, the competition is poised to intensify next year. Sandoz’s Enzeevu, for one, is allowed to launch in the fourth quarter of 2026, or earlier in “certain circumstances,” under that company's recent agreement with Regeneron. Enzeevu is an interchangeable biosimilar, meaning it can be substituted at the pharmacy counter without a new prescription from a doctor.Biocon and Mylan became the first to settle with Regeneron back in April, allowing their interchangeable Yesafili to launch in the second half of 2026. Regeneron is still blocking Samsung Bioepis’ Opuviz and Formycon’s Ahzantive biosimilars from launching and hasn’t given up on its dispute with Amgen, filing another complaint as recently as June. Eylea pulled down $1.1 billion in U.S. sales last quarter, a 25% fall from the same period last year.

Drug ApprovalPatent InfringementBiosimilarLicense out/in

09 Sep 2025

·www.fiercepharma.com

With settlement, Sandoz can launch its biosimilar to Regeneron's Eylea by end of 2026

Regeneron, already facing Eylea biosimilar competition in the U.S. from Amgen, has made a deal with Sandoz. Regeneron and Sandoz have reached a settlement that resolves all patent litigation related to the Swiss company’s biosimilar version of eye disease drug Eylea.The settlement allows Sandoz to launch its biosimilar Enzeevu in the fourth quarter of 2026 or earlier under some circumstances, the company said. Financial terms of the deal were not disclosed.The settlement ends litigation that began in August of last year, two weeks after the FDA approved Enzeevu. Regeneron claimed that the generics giant infringed 46 of its patents on Eylea, some of which expire as late as 2040.In its lawsuit, the New York company also claimed that Sandoz violated the Biologics Price Competition and Innovation Act, which accelerates the approval process for biosimilars and requires manufacturers that create them to provide information to the company that markets the reference product. Regeneron said the information was never provided.Enzeevu was approved as an interchangeable biosimilar, which means it is a clinical match to the reference product and can be substituted at the pharmacy counter without a new prescription from a doctor.In April of this year, Regeneron settled another Eylea patent dispute with Biocon Biologics, allowing the latter to commercialize its interchangeable biosimilar Yesafili in the second half of 2026.Regeneron is already dealing with Eylea biosimilar competition in the U.S. from Amgen, which began selling its version, Pavblu, in November of last year. The launch came seven weeks after a West Virginia judge blocked Regeneron’s bid for a preliminary injunction to prevent it. Amgen reported Pavblu generated revenue of $229 million in the first half of this year. Meanwhile, since Pavblu’s launch, Regeneron’s sales of Eylea have dipped dramatically, from $1.19 billion in the fourth quarter of last year to $754 million in the second quarter.Pavblu is in competition with the original 2-mg dosage version of Eylea. Regeneron’s high-dose (8-mg) version of the treatment, Eylea HD, remains under patent protection but faces stiff competition from Roche’s Vabysmo, which racked up sales of 2.1 billion Swiss francs ($2.4 billion) worldwide in the first half of this year.Meanwhile, the two Eylea formulations generated $2.5 billion in U.S. sales in the first half of this year, compared to a $3.1 billion figure for the first half of 2022, which is when Vabysmo reached the market. Regeneron is jousting with several other companies over their plans to launch Eylea biosimilars, including Biogen and Samsung Bioepis’ Opuviz. Celltrion and Formycon also have Eylea biosims in the works.Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. This mechanism helps in managing and treating conditions that lead to vision loss. In addition to its age-related macular degeneration nod, Eylea has been endorsed by the FDA to treat diabetic macular edema, retinal vein occlusion, diabetic retinopathy and retinopathy of prematurity.

Drug ApprovalPatent InfringementBiosimilarPatent Expiration

100 Deals associated with AFLIBERCEPT-JBVF

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Vision, Low	Canada	Biocon Biologics Ltd. (India)	27 Jun 2025
Diabetic Retinopathy	United States	Biocon Biologics, Inc.	20 May 2024
Diabetic macular oedema	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03610646 (not provided, Pubmed \| JAMA Ophthalmol)	Phase 3	Diabetic macular oedema	355	MYL-1701P	bytkyeyicv(lghuekrzwm) = stilnpruls wtndxccvln (pykxvrinfq, 0.55) View more	Positive	12 Sep 2024
				Aflibercept	bytkyeyicv(lghuekrzwm) = enwrhpsgcn wtndxccvln (pykxvrinfq, 0.55) View more
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	906	Aflibercept 2 mg Q8 weeks	hblzzapgar(duqrkmmwsp) = krdcmsllus wxzxbrihyx (nqxwbqxwdr ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	hblzzapgar(duqrkmmwsp) = spisommoqn wxzxbrihyx (nqxwbqxwdr ) View more
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	181	Aflibercept 2 mg Q4 weeks	ynnzxlbkja(qjepqjrhqs) = vgsgnkrpip eryoxzyxkb (jljrmpfsgc ) View more	Superior	20 May 2024
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	297	Aflibercept 2 mg Q8 weeks	agkafeegpf(eetzphjvcd) = uysjbrsnwd mznaknwodq (gjdyerfyzg )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	agkafeegpf(eetzphjvcd) = xfdoditqwr mznaknwodq (gjdyerfyzg )
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	187	Aflibercept 2 mg Q4 weeks	ffkplbesgv(xybtdjegnm) = khpphnyihd hcgcgjadvi (lvaytfmmfn ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	905	Aflibercept 2 mg Q8 weeks	pifhkcagit(mzadvyysge) = pkvcoyekft rmsmqhqbeo (ymtaiidmby ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	pifhkcagit(mzadvyysge) = ncfwdjfyac rmsmqhqbeo (ymtaiidmby ) View more
FDA_CDER Manual	Phase 3	Diabetic macular oedema	459	Aflibercept 2 mg Q8	gyowowakcy(oifvmsavwh) = cuiqhzicpw koxcvxichc (rchacyorcs, 8.2) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	gyowowakcy(oifvmsavwh) = uyivxljnfx koxcvxichc (rchacyorcs, 9.5) View more
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	171	Aflibercept 2 mg Q4 weeks	eyekhsjaby(bhfngufima) = acvqhbnoap gwjxqibxfx (mlxwqaarzz ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Diabetic macular oedema	403	Aflibercept 2 mg Q8 weeks	buignnlorg(kmsceehcfq) = gkwfvwrtvd quncpfkmfr (lhbqxiiktx, 9.3) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	buignnlorg(kmsceehcfq) = rwwvtvlaob quncpfkmfr (lhbqxiiktx, 9.6) View more
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	451	Aflibercept 2 mg Q8 weeks	ehuvhjlhmk(gxolvdvwxx) = alkrhnfpua pjpoalfpti (cjtpxuubbu )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	ehuvhjlhmk(gxolvdvwxx) = btqzsrnuvq pjpoalfpti (cjtpxuubbu )

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