Delving into the Latest Updates on AFLIBERCEPT-JBVF with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

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

+ [1]

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

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Diabetic RetinopathyDiabetic macular oedemaMyopic choroidal neovascularization+ [2]

Inactive Indication-

Originator Organization

Viatris, Inc.

Active Organization

Inactive Organization

Mylan Pharmaceuticals, Inc.

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: *****

Author: Agrawal, Virendra ; Zeitz, Oliver ; Ganapathi, Prasanna C. ; Varsanyi, Balazs ; Oh, Hideyasu ; Stoller, Glenn L ; Furuta, Minoru ; Brown, David M ; Ghorayeb, Ghassan R ; Mazumdar, Shahana ; Zalewski, Dominik ; Barakat, Mark R ; Chang, Margaret A ; Korda, Vladimir ; Ojima, Akira ; Kalvodova, Bohdana ; Chaudhry, Nauman A ; Apte, Rajendra S. ; Vajas, Attila ; Chauhan, Rohan R ; Barve, Abhijit ; Kobayashi, Namie ; Kitaoka, Takashi ; Mansour, Sam E ; Laganovska, Guna ; Muramatsu, Tomoyuki ; Grisanti, Salvatore ; K, Minija C ; Studnicka, Jan ; Dessouki, Amr L ; Agarwal, Somesh ; Gombos, Katalin ; Zolotarev, Andrey ; Kellner, Ulrich ; Behera, Umesh Chandra ; Alfaro, Daniel Virgil ; Nemcansky, Jan ; PD, Katrin Lorenz ; Agarwal, Komal ; Reichstein, David A. ; Radnoti, Judit ; Natesh, Sribhargava ; Veith, Miroslav ; Narayanan, Raja ; Thach, Allen B ; Rehak, Jiri ; Dégi, Rozsa ; Kaza, Hrishikesh ; Tabassian, Ali R ; Kannan, Naresh Babu ; Rahul, Shroff ; Yadav, Naresh Kumar ; Noge, Sumiyo ; Fox, Gregory M ; Davies, John B ; Fujita, Hideaki ; Shkvorchenko, Dmitry ; Fluder, Ewa Maria ; Astakhov, Yury ; Tanabe, Teruyo ; Astakhov, Sergei ; Kerenyi, Agnes ; Krzyzanek, Daniel ; Elhence, Arti ; Tsorbatzoglou, Alexis ; Loganathan, Subramanian ; Panchal, Bhavik ; Yoshizumi, Yuki ; Ebihara, Nobuyuki ; Baumane, Kristine ; Kamei, Motohiro ; Beckmann, Katrin ; Doi, Norihito ; Imaizumi, Hiroko ; Patel, Sunil S. ; Gamulescu, Maria- Andreea ; Izmaylov, Alekxandr ; Borcz, Emilia ; Gupta, Vishali ; Sekundo, Walter ; Eremina, Alena ; Oshima, Yuji ; Seres, Andras ; Ernest, Jan ; Wylegala, Edward ; Raj, Lional ; Marcus, Dennis M. ; Ozolina, Signe ; Samoylov, Alexandr ; Patel, Sunil S ; Otake, Hiroshi ; Nawrocki, Jerzy ; Kiss, Katalin K ; Bressler, Susan B. ; Eichenbaum, David A ; Oleksy, Piotr ; Watanabe, Miki ; Johnson, Thomas Mark ; Berger, Adam S ; Stodulka, Pavel ; Kawasaki, Tsutomu ; Degi, Rozsa ; Saito, Isao ; Hanemoto, Tsukasa ; Lebedev, Oleg ; Fine, Howard F ; Gordon, Alan J ; Angle, Bryan N ; Feltgen, Nicolas ; Reichstein, David A ; Sonawane, Ashwini ; Kaga, Tatsushi ; Saravanan, Veerappan R ; Murata, Koji ; Abe,, Keitetsu ; Sawada, Osamu ; Budzinskaya, Maria ; Aggarwal, Somesh ; Dugel,, Pravin U ; Dahlke, Claudia ; Ishii, Kiyoshi ; Marcus, Dennis M ; Matsuda, Satoshi ; Baker, Carl W ; Sjaarda, Raymond N ; Kishino, Genichiro ; Vohra, Rajpal

ImportanceBiosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).ObjectiveTo compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.Design, Setting, and ParticipantsThis 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.InterventionsFormulations 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 MeasuresThe 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).ResultsA 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 RelevanceMYL-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 RegistrationClinicalTrials.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: S E Svehag ; H H Jepsen ; B Teisner ; J M Rasmussen

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·Immunopharmacology and Immunotoxicology

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

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.

15

News (Medical) associated with AFLIBERCEPT-JBVF

23 Oct 2024

·www.biospace.com

Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings-Catalent Merger

iStock, Robert Way Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo. Roche on Wednesday released its third-quarter earnings report , posting nearly $17.5 billion in sales, representing 9% year-on-year growth and exceeding Wall Street expectations. According to Jefferies analyst Peter Welford, Roche’s Q3 sales were 1% ahead of the consensus estimate. The company’s pharmaceuticals division, which remains its strongest unit with $13.4 billion in the quarter, beat analysts’ expectations by 2%. Roche’s top-performing asset in the quarter was the multiple sclerosis drug Ocrevus, which grew 11% to bring in almost $2 billion. Despite mounting biosimilar competition in the eye diseases space, Roche’s intravitreal injection Vabysmo continues its strong market momentum. The age-related macular degeneration (AMD) treatment surged 59% year-over-year, bringing in nearly $1.2 billion in Q3. Vabysmo, a dual inhibitor of VEGF and angiopoietin-2, is also indicated for diabetic macular edema (DME). In May 2024, the FDA greenlit two biosimilars to Regeneron’s blockbuster therapy Eylea—Samsung Bioepis and Biogen’s Opuviz and Biocon Biologics’ Yesafili—which are expected to compete with Vabysmo in the AMD and DME markets. On the negative side of the Q3 ledger, Roche’s PD-L1 antibody Tecentriq was “weak” in the quarter, according to Jefferies’ Welford, noting that its sales of just over $1 billion fell short of consensus estimates. Looking forward to the rest of the year, Roche reiterated its business outlook with growth of around mid-single-digit in group sales and in the high-single-digit range for core earnings-per-share. Opposition to Novo-Catalent Deal On the M&A front, Roche is urging regulatory authorities to block Novo Holdings’ proposed $16.5 billion acquisition of CDMO giant Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Roche CEO Thomas Schinecker said in a media call Wednesday morning, however insisting that the company itself would not be affected by the merger, according to Reuters . The acquisition would further restrict the contract manufacturing ecosystem, Schinecker said, which “could be a problem for other smaller players.” “From an industry perspective, it would be a wrong decision by authorities” if they let the transaction proceed, according to Schinecker. Pressure on the deal has been mounting. Last week, more than 10 unions, consumer organizations and public interest groups wrote to the Federal Trade Commission , urging the antitrust watchdog to “challenge” the proposed acquisition and to ensure that “competition is protected.” Sen. Elizabeth Warren (D-Mass.) earlier this month also flagged potential anti-competitive concerns with the transaction. In a letter to the FTC, Warren warned that the acquisition of contract manufacturer Catalent could increase Novo Nordisk’s dominance over the hot GLP-1 market, reducing competition and increasing prices. Referring to rival Eli Lilly, Warren said the deal could give Novo Nordisk “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices,” as well as “the ability to preference its own products and obstruct its competitors’ use of Catalent to produce GLP-1 drugs.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We do rely on one of the Catalent sites for GLP-1 and other diabetes production,” Ricks told analysts. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens.”

Acquisition

24 Sep 2024

·www.fiercepharma.com

Regeneron's stock drops as it loses bid to block Amgen's Eylea biosimilar

Regeneron suffered a setback in its defense of blockbuster eye drug Eylea, startling investors. Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.In an order issued under seal—which would explain his decision—Judge Thomas Kleeh of the U.S. District Court for Northern District of West Virginia denied Regeneron’s request for a preliminary injunction which would prevent Amgen’s Pavblu from entering the market.The knockoff, which replicates the original 2 mg version of Bayer and Regeneron’s Eylea, was approved by the FDA last month. In its complaint against Amgen, which was filed in January of this year, Regeneron listed 32 patents it claimed were infringed. Upon the decision, the company immediately filed an appeal."We are disappointed in the court decision that was specific to Amgen only. Importantly, this decision has no effect on previous decisions against other biosimilars manufacturers of Eylea," Regeneron said in an emailed statement. "We continue to believe that Amgen is infringing our patent rights, and this decision denying our request for a preliminary injunction is not the final word in this litigation. We have appealed this decision, and we also look forward to presenting our case at trial."The New York-based company’s regulatory exclusivity for Eylea—which was originally approved in 2011 to treat wet age-related macular degeneration (AMD)—expired in May, according to the complaint.As Regeneron's case plays out, Amgen could now pursue an "at-risk" biosimilar launch. Under such an approach, the biosimilar maker would be liable for damages should Regeneron ultimately prevail in establishing patent infringement.In the wake of the injunction decision, Regeneron’s shares dropped roughly 9% between Monday and Tuesday, an indicator of the company’s reliance on Eylea.With U.S. sales of $5.9 billion in 2023, the vascular endothelial growth factor (VEGF) inhibitor accounted for 44% of Regeneron revenue of $13.1 billion.An Amgen spokesperson said that the company will "announce our launch timing in due course," Eylea’s market share has been dented by Roche’s longer-acting Vabysmo, which requires dosing as little as every four months as opposed to every other month for Eylea. Regeneron has since countered with a high-dose (8 mg) version of Eylea. In the second quarter, Eylea HD accounted for $304 million of the $1.53 billion generated overall by the Eylea franchise. The Amgen ruling runs counter to Kleeh’s decisions three days apart in June when he granted Regeneron’s requests for preliminary injunctions, blocking the sale of Biogen and Samsung Bioepis’ Eylea biosimilar Opuviz and Biocon’s Eylea copycat Yesafili until 2027. The court ruled that both knockoffs infringed Regeneron patents.Opuviz and Yesafili were approved by the FDA in May as interchangeable biosimilars, meaning that a pharmacist can freely switch them out for the reference product. Regeneron’s defense of Eylea is a high-priority endeavor for the drugmaker. Four weeks ago, the company filed a lawsuit in New Jersey against Sandoz and its Eylea biosimilar. The company also is jousting with South Korea-based Celltrion and Germany-based Formycon over their Eylea biosimilars.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 AMD nod, Eylea has been endorsed by the FDA to treat diabetic macular edema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR) and retinopathy of prematurity (ROP).

Drug ApprovalPatent InfringementBiosimilar

29 Aug 2024

·www.biospace.com

Regeneron Sues Sandoz in Federal Court to Block Eylea Biosimilar

Photo of a judge’s gavel, a balance and a stack of papers iStock, lakshmiprasad S In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act. Regeneron Pharmaceuticals this week filed a lawsuit against Sandoz claiming that the generics giant’s recently approved biosimilar to Eylea (aflibercept) infringes on the pharma’s patent protections. In its legal complaint, filed in the District Court for New Jersey, Regeneron cites the Biologics Price Competition and Innovation Act (BPCIA), which speeds up the regulatory process for biosimilars. Under the BPCIA, biosimilar developers are required to provide specific information relevant to the proposed copycat and the reference branded product. This disclosure should be made within 20 days after the FDA accepts the biosimilar application for review, according to Regeneron’s lawsuit. However, the pharma alleges that Sandoz did not turn over the BPCIA-required information, even after the biosimilar had cleared regulatory review. “It is abundantly clear that well over 20 days have elapsed the FDA’s acceptance” of the abbreviated Biologics License Application (aBLA), “yet Sandoz still has not provided the information to Regeneron,” according to the lawsuit. “Sandoz’s failure to provide this information is a violation of the BPCIA that authorizes Regeneron to bring claims for patent infringement against Sandoz,” the pharma claimed. Regeneron is asking a judge to prevent Sandoz from marketing its biosimilar and for monetary relief. The drug at the center of this legal battle is Eylea , a blockbuster anti-VEGF recombinant fusion protein indicated for neovascular age-related macular degeneration (AMD), retinal vein occlusion, diabetic retinopathy and other eye diseases. Eylea works by acting as a decoy receptor against both the VEGF-A and PIGF ligands, disrupting their downstream cascades and preventing the growth of abnormal blood vessels in the eye. Since its first approval in 2011 for neovascular AMD, Eylea has become one of Regeneron’s top assets. Last year, the blockbuster eye injection brought in over $5.7 billion , a 9% dip from 2022. According to the pharma, the slowdown in Eylea sales is due to “changing market dynamics, resulting in a lower net selling price and lower volumes.” The entry of biosimilar competitors has contributed to the declining sales of Eylea. In May 2024, the FDA approved two copycats —Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Both biosimilars also have the interchangeability designation, allowing their use instead of Eylea without needing to change the prescription. Earlier this month, the FDA signed off on Sandoz’s own biosimilar, dubbed Enzeevu (aflibercept-abzv). Like Yesafili and Opuvis, Enzeevu is also interchangeable with Eylea, though the designation is still provisional “subject to an unexpired exclusivity for the first interchangeable biosimilar products,” according to the company.

Drug ApprovalPatent Infringement

100 Deals associated with AFLIBERCEPT-JBVF

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetic Retinopathy	United States	Biocon Biologics, Inc.	20 May 2024
Diabetic macular oedema	Liechtenstein	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	European Union	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Norway	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Iceland	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Liechtenstein	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	European Union	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Norway	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Iceland	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Iceland	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Norway	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	European Union	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Liechtenstein	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	European Union	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Liechtenstein	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Iceland	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Norway	Biosimilar Collaborations Ireland Ltd.	15 Sep 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Preclinical	United States	Mylan Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Latvia	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Japan	Mylan Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Germany	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Hungary	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Poland	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Czechia	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	United States	Momenta Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	Czechia	Mylan Pharmaceuticals, Inc.	23 Aug 2018
Diabetic macular oedema	Preclinical	India	Momenta Pharmaceuticals, Inc.	23 Aug 2018

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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	(iobvjbrvmw) = qmyyhfyvyc mlrbcbzrxb (brzjllthlw, 0.55) View more	Positive	12 Sep 2024
				Aflibercept	(iobvjbrvmw) = zylvtnlggs mlrbcbzrxb (brzjllthlw, 0.55) View more
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	171	Aflibercept 2 mg Q4 weeks	(dmjqdodawr) = xkovfvxpwv isbxsxhuma (nvvpdqracp ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Diabetic macular oedema	403	Aflibercept 2 mg Q8 weeks	(vlavogefef) = pokofgvtnb mkbyfypjpj (nxapftzrpj, 9.3) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(vlavogefef) = lzzsgavrng mkbyfypjpj (nxapftzrpj, 9.6) View more
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	451	Aflibercept 2 mg Q8 weeks	(sylcjgtarh) = cxbfgaxqxs qzogctxsoz (mdmaizfqxj )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(sylcjgtarh) = mmkzuydjwu qzogctxsoz (mdmaizfqxj )
FDA_CDER Manual	Phase 3	Diabetic macular oedema	459	Aflibercept 2 mg Q8	(uwfoedbqrj) = hdwaqbiuik pcjiemwpxh (gvuffnvncy, 8.2) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(uwfoedbqrj) = ujyrucqogu pcjiemwpxh (gvuffnvncy, 9.5) View more
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	297	Aflibercept 2 mg Q8 weeks	(utnysxuobn) = stlrnzihlc qkbxjchtrm (fcccezgbpz )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(utnysxuobn) = xycoyrwzqt qkbxjchtrm (fcccezgbpz )
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	187	Aflibercept 2 mg Q4 weeks	(gxxrahzugf) = ulhrvhnpho zyszlqudty (ceclyzblks ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	181	Aflibercept 2 mg Q4 weeks	(fobqltlohk) = orgvcnkwmu rafillxwjm (rbjhvfotvp ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	905	Aflibercept 2 mg Q8 weeks	(jvatoajuax) = vmfkduishj bqndnbdrqk (vuagvbhmbw ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(jvatoajuax) = lzsuzqnqbc bqndnbdrqk (vuagvbhmbw ) View more
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	906	Aflibercept 2 mg Q8 weeks	(flntomdhwv) = mvxhuwliar fsqtlyvrsp (ygjlqxlqnm ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	(flntomdhwv) = ohwwsywezj fsqtlyvrsp (ygjlqxlqnm ) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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