A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB15 (proposed aflibercept biosimilar) and Eylea® in Subjects with Neovascular Age-related Macular Degeneration

Start Date07 May 2020

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with AFLIBERCEPT-YSZY

100 Translational Medicine associated with AFLIBERCEPT-YSZY

100 Patents (Medical) associated with AFLIBERCEPT-YSZY

Literatures (Medical) associated with AFLIBERCEPT-YSZY

01 Dec 2023·BMJ open ophthalmology

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Article

Author: Studnička, Jan ; Oh, Inkyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Sadda, SriniVas R ; Jang, Hyerin ; Choi, Wooree ; Tóth-Molnár, Edit ; Enyedi, Lajos ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Background/aims:

To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

Design:

Prospective, double-masked, randomised, phase 3 trial.

Methods:

Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.

Results:

Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.

Conclusions:

Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

01 Jul 2023·JAMA ophthalmology

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.

Article

Author: Kim, Taehyung ; Oh, Inkyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Jang, Hyerin ; Tóth-Molnár, Edit ; Enyedi, Lajos ; Patel, Sunil ; Wylegala, Edward ; Sadda, SriniVas R ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Studnicka, Jan ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Importance:

Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.

Objective:

To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).

Design, Setting, and Participants:

This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.

Intervention:

Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.

Main Outcomes and Measures:

The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of -3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.

Results:

The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, -110.4 μm vs AFL, -115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.

Conclusions and Relevance:

In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04450329.

01 Jun 2023·Materials today. Chemistry

COVID-19 impedimetric biosensor based on polypyrrole nanotubes, nickel hydroxide and VHH antibody fragment: specific, sensitive, and rapid viral detection in saliva samples

Article

Author: Baêta Rodrigues, D S ; Hiraiwa, P M ; Zanchin, N I T ; Macedo de Souza Brandão, A P ; Deller, A E ; Guimarães, B G ; Vidotti, M ; Soares, F L F ; Hryniewicz, B M ; Camargo de Oliveira, C ; Bach-Toledo, L ; Schuster da Silva, S ; Santos, A ; Abreu, H ; Gradia, D F ; Marchesi, L F ; Rogerio, V Z ; Carvalho de Oliveira, J

SARS-CoV-2 rapid spread required urgent, accurate, and prompt diagnosis to control the virus dissemination and pandemic management. Several sensors were developed using different biorecognition elements to obtain high specificity and sensitivity. However, the task to achieve these parameters in combination with fast detection, simplicity, and portability to identify the biorecognition element even in low concentration remains a challenge. Therefore, we developed an electrochemical biosensor based on polypyrrole nanotubes coupled via Ni(OH)₂ ligation to an engineered antigen-binding fragment of heavy chain-only antibodies (VHH) termed Sb#15. Herein we report Sb#15-His6 expression, purification, and characterization of its interaction with the receptor-binding domain (RBD) of SARS-CoV-2 in addition to the construction and validation of a biosensor. The recombinant Sb#15 is correctly folded and interacts with the RBD with a dissociation constant (K_D) of 27.1 ± 6.4 nmol/L. The biosensing platform was developed using polypyrrole nanotubes and Ni(OH)₂, which can properly orientate the immobilization of Sb#15-His6 at the electrode surface through His-tag interaction for the sensitive SARS-CoV-2 antigen detection. The quantification limit was determined as 0.01 pg/mL using recombinant RBD, which was expressively lower than commercial monoclonal antibodies. In pre-characterized saliva, both Omicron and Delta SARS-CoV-2 were accurately detected only in positive samples, meeting all the requirements recommended by the World Health Organization for in vitro diagnostics. A low sample volume of saliva is needed to perform the detection, providing results within 15 min without further sample preparations. In summary, a new perspective allying recombinant VHHs with biosensor development and real sample detection was explored, addressing the need for accurate, rapid, and sensitive biosensors.

News (Medical) associated with AFLIBERCEPT-YSZY

20 Sep 2024

·pipelinereview.com

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 2 (aflibercept), also known as SB15. OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with retinal disorders as we are making a step forward in enhancing the availability of the essential treatment,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies. 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,” she added. “We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.” The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for OPUVIZ. If a marketing authorization is granted by the EC, OPUVIZ would become the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe, Japan and Australia. About the SB15 Phase 3 study 3 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . SOURCE: Samsung Bioepis

Phase 3Clinical ResultLicense out/inDrug Approval

20 Sep 2024

·www.fiercepharma.com

Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius

This marks the third rejection this year for pegcetacoplan in Europe, where there are currently no approved therapies for GA. Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again.Europe’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its negative stance on pegcetacoplan in geographic atrophy (GA), an advanced form of age-related macular degeneration that can lead to blindness, Apellis said Friday.This marks the third rejection this year for pegcetacoplan in Europe, where there are currently no approved therapies for GA. The CHMP initially snubbed the drug in January and then again in June. Apellis has spent much of the year appealing the agency’s decisions.Apellis is “deeply disappointed” by the latest rejection, the company’s co-founder and CEO, Cedric Francois, M.D., Ph.D., said in a statement. The negative opinion was handed down despite “broad support” for pegcetacoplan from the European retina community and “multiple dissenting votes” by CHMP members, the CEO said. Pegcetacoplan was initially approved in the U.S. for the rare blood disorder paroxysmal nocturnal hemoglobinuria in 2022 under the brand name Syfovre. Syfovre subsequently won an FDA nod in GA in February of 2023.In the U.S., Syfovre’s GA rollout has been tumultuous thanks to side effects concerns, Medicare hiccups and more. All told, Syfovre generated $154.6 million in 2024’s second quarter. As of August, the medicine remained the U.S. market leader in GA, Apellis said in its latest earnings release.As for the CHMP’s rationale behind its rejection, the agency said that while Syfovre’s phase 3 OAKS and DERBY studies showed that the med slowed the growth of GA lesions, it failed to lead to clinically meaningful benefits for patients. Further, regular injections into the eye carry a significant risk of side effects and safety events, including developing other forms of AMD or inflammation that could worsen vision, the regulator pointed out.European regulators are also reviewing Astellas Pharma’s Izervay for GA. The Japanese drugmaker’s medicine won U.S. approval in the eye condition last August.Syfovre was the odd man out Friday as the CHMP announced multiple other approval recommendations—all of which were positive.The drugs that got the thumbs up were ImmunoGen’s Elahere in ovarian, fallopian tube or primary peritoneal cancer; Henlius’ Hetronifly in extensive-stage small cell lung cancer; Pfizer’s Hympavzi to treat bleeding episodes in teens and adults with hemophilia A or B; Pfizer’s meningococcus vaccine Penbraya; Eckert & Ziegler Radiopharma’s radiopharmaceutical precursor Theralugand; the biosimilars for age-related macular degeneration Afqlir and Opuviz; and Teva’s generic version of pomalidomide for multiple myeloma treatment.Ipsen also received good news from European regulators Friday as the company has secured conditional approval from the European Commission (EC) for its drug Iqirvo in the rare liver disease primary biliary cholangitis (PBC).The EC based its decision upon a prior CHMP recommendation leveraging data from Ipsen’s late-stage ELATIVE study. In the trial, 51% of patients on 80 mg of Iqirvo achieved a biochemical response versus just 4% of patients in the control arm, Ipsen said in a release. The positive update across the pond comes after Iqirvo snagged an FDA nod in the same condition back in June.The timing may be beneficial for Ipsen, given that Intercept’s PBC rival Ocaliva is now facing an uncertain future in Europe. Several weeks ago, the EC moved to revoke Intercept’s conditional marketing nod in PBC, though the General Court of the European Union cut in and has temporarily suspended the EC’s decision.

Phase 3Drug ApprovalClinical ResultAccelerated Approval

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-YSZY

R&D Status

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Indication	Country/Location	Organization	Date
Diabetic Retinopathy	US	Samsung Bioepis Co., Ltd.	20 May 2024
Diabetic macular oedema	KR	Samsung Bioepis Co., Ltd.	23 Feb 2024
Myopic choroidal neovascularization	KR	Samsung Bioepis Co., Ltd.	23 Feb 2024
Retinal vein occlusion-related macular edema	KR	Samsung Bioepis Co., Ltd.	23 Feb 2024
Wet AMD	KR	Samsung Bioepis Co., Ltd.	23 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04450329 (CTgov)	Phase 3	Wet AMD	449	SB15 (Proposed aflibercept biosimilar) (SB15 (Proposed Aflibercept Biosimilar))	kbzflcibwd(dxvrdnrwob) = pbcslgghhb lfphftasnc (vguvoopwkz, qdajhvtbdg - rhbemkbdfl) View more	-	05 Feb 2024
				SB15 (Proposed aflibercept biosimilar) (Eylea (Aflibercept))	kbzflcibwd(dxvrdnrwob) = beabaxdbth lfphftasnc (vguvoopwkz, rbudntkpzs - jabotuqwld) View more
EURETINA2023 Manual	Phase 3	Wet AMD	438	SB15	fgnwarcszc(gajhdayrwv) = kolevdoemn waizkdmnoy (mzkeuqdely ) View more	Positive	05 Oct 2023
				Aflibercept	fgnwarcszc(gajhdayrwv) = agahlypnhx waizkdmnoy (mzkeuqdely ) View more
EURETINA2023 Manual	Phase 3	Age Related Macular Degeneration	449	SB15	kbfnnjjeim(qseqxhmxte) = qjtrwohsgl mwzpaziqvr (hrbdbkodcx )	Similar	05 Oct 2023
				Aflibercept	kbfnnjjeim(qseqxhmxte) = unahrvvkud mwzpaziqvr (hrbdbkodcx )
NCT04450329 (Pubmed)	Phase 3	Age Related Macular Degeneration	449	SB15	gxpuicepeg(lfocigkrox) = umkkimzowh chmptpkqrh (gizoxqmorg ) View more	-	08 Jun 2023
				AFL	gxpuicepeg(lfocigkrox) = lrxlrhkmsf chmptpkqrh (gizoxqmorg ) View more
Phase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration (ARVO2023)	Phase 3	Wet AMD	449	SB15 2 mg	flkntrbrro(zuxtbmvngn) = qcqilefykt cutieqrczw (pzjrucmblf )	Positive	01 Jun 2023
				Aflibercept	flkntrbrro(zuxtbmvngn) = jkeiiprjlh cutieqrczw (pzjrucmblf )
AAO2022	Phase 3	Wet AMD	-	SB15	hbnmpmwthv(jarmqxqoul) = ohbkdoxzaj lttjwpgriy (ufsfuplpqb )	Positive	29 Sep 2022
				Aflibercept	hbnmpmwthv(jarmqxqoul) = pvlycuzvdg lttjwpgriy (ufsfuplpqb )

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