{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T07:50:13Z","timestamp":1787903413612,"version":"build-2784847793"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,16]]},"DOI":"10.7759\/cureus.108999","type":"journal-article","created":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T05:57:00Z","timestamp":1778997420000},"source":"Crossref","is-referenced-by-count":2,"title":["Semaglutide and Follow-On Peptide Therapeutics: Balancing Innovation, Regulation, and Clinical Outcomes"],"prefix":"10.7759","author":[{"given":"Brij","family":"Teli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shrikant","family":"Somani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Arya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prashant J","family":"Rajput","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pravin","family":"Kahale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vahid","family":"Bharmal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shalin","family":"Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anand","family":"Ahuja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonali","family":"Patange","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-024-03771-6","article-title":"Impact of manufacturing process and compounding on properties and quality of follow-on GLP-1 polypeptide drugs","volume":"41","author":"Hach M","year":"2024","unstructured":"Hach M, Engelund DK, Mysling S, et al.. Impact of manufacturing process and compounding on properties and quality of follow-on GLP-1 polypeptide drugs. Pharm Res. 2024, 41:1991-2014. 10.1007\/s11095-024-03771-6","journal-title":"Pharm Res"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.3390\/ph18030399","article-title":"Semaglutide as a GLP-1 agonist: a breakthrough in obesity treatment","volume":"18","author":"Salvador R","year":"2025","unstructured":"Salvador R, Moutinho CG, Sousa C, Vinha AF, Carvalho M, Matos C. Semaglutide as a GLP-1 agonist: a breakthrough in obesity treatment. Pharmaceuticals (Basel). 2025, 18:399. 10.3390\/ph18030399","journal-title":"Pharmaceuticals (Basel)"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.5281\/zenodo.18672906","article-title":"A comprehensive review of regulatory requirements and approval pathways for peptide therapeutics in the USA and India","volume":"4","author":"Praveen RB","year":"2026","unstructured":"Praveen RB, Raghavan V, Iswareyaa RA. A comprehensive review of regulatory requirements and approval pathways for peptide therapeutics in the USA and India. Int J Pharm Sci. 2026, 4:2740-55. 10.5281\/zenodo.18672906","journal-title":"Int J Pharm Sci"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1021\/acscombsci.0c00134","article-title":"Total synthesis of semaglutide based on a soluble hydrophobic-support-assisted liquid-phase synthetic method","volume":"22","author":"Liu X","year":"2020","unstructured":"Liu X, Zhang N, Gu X, Qin Y, Song D, Zhang L, Ma S. Total synthesis of semaglutide based on a soluble hydrophobic-support-assisted liquid-phase synthetic method. ACS Comb Sci. 2020, 22:821-5. 10.1021\/acscombsci.0c00134","journal-title":"ACS Comb Sci"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2025.116682","article-title":"Peptide mapping analysis of synthetic semaglutide and liraglutide for generic development of drugs originating from recombinant DNA technology","volume":"256","author":"Kim SH","year":"2025","unstructured":"Kim SH, Kim SS, Kim HJ, Park EJ, Na DH. Peptide mapping analysis of synthetic semaglutide and liraglutide for generic development of drugs originating from recombinant DNA technology. J Pharm Biomed Anal. 2025, 256:116682. 10.1016\/j.jpba.2025.116682","journal-title":"J Pharm Biomed Anal"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.3390\/biom14030264","article-title":"Exploring FDA-approved frontiers: insights into natural and engineered peptide analogues in the GLP-1, GIP, GHRH, CCK, ACTH, and \u03b1-MSH realms","volume":"14","author":"Al Musaimi O","year":"2024","unstructured":"Al Musaimi O. Exploring FDA-approved frontiers: insights into natural and engineered peptide analogues in the GLP-1, GIP, GHRH, CCK, ACTH, and \u03b1-MSH realms. Biomolecules. 2024, 14:264. 10.3390\/biom14030264","journal-title":"Biomolecules"},{"key":"ref7","unstructured":"Production of semaglutide. process modeling and cost analysis using SuperPro Designer\u00ae. (2025). https:\/\/www.researchgate.net\/profile\/Demetri-Petrides\/publication\/392573822_Semaglutide_Ozempic_and_Wegovy_Manufactur...."},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-025-03843-1","article-title":"Immunogenicity of generic peptide impurities: current orthogonal approaches","volume":"42","author":"De Groot AS","year":"2025","unstructured":"De Groot AS, Mattei A, Gabriel B, et al.. Immunogenicity of generic peptide impurities: current orthogonal approaches. Pharm Res. 2025, 42:805-18. 10.1007\/s11095-025-03843-1","journal-title":"Pharm Res"},{"key":"ref9","unstructured":"ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin guidance for industry. (2021). Accessed. 20 March 2026: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/andas-certain-highly-purified-synthetic-pept...."},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2024.1335928","article-title":"Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals","volume":"11","author":"Klein K","year":"2024","unstructured":"Klein K, Heisterberg J, Stolk P. Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals. Front Med (Lausanne). 2024, 11:1335928. 10.3389\/fmed.2024.1335928","journal-title":"Front Med (Lausanne)"},{"key":"ref11","unstructured":"Guidance document for BA\/BE NOC for export. (2018). Accessed. 20 March 2026: https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/BA_BE\/guidance_doc_BABE_NOC1_1Jan2018.pdf."},{"key":"ref12","unstructured":"How the committees work. (2026). Accessed. 28 April 2026: https:\/\/www.ema.europa.eu\/en\/committees\/how-committees-work."},{"key":"ref13","unstructured":"Legal framework. (2026). Accessed. 28 April 2026: https:\/\/www.ema.europa.eu\/en\/about-us\/what-we-do\/legal-framework."},{"key":"ref14","unstructured":"Guideline on similar biological medicinal products. (2014). Accessed. 28 April 2026: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-similar-biological-medicinal-products-rev1_en.pdf."},{"key":"ref15","unstructured":"QRD general principles regarding the SmPC information for a generic\/hybrid\/biosimilar product. (2018). Accessed. 28 April 2026: https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/quality-review-documents-general-principles-re...."},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2023.103714","article-title":"Immunogenicity risk assessment of synthetic peptide drugs and their impurities","volume":"28","author":"De Groot AS","year":"2023","unstructured":"De Groot AS, Roberts BJ, Mattei A, Lelias S, Boyle C, Martin WD. Immunogenicity risk assessment of synthetic peptide drugs and their impurities. Drug Discov Today. 2023, 28:103714. 10.1016\/j.drudis.2023.103714","journal-title":"Drug Discov Today"},{"key":"ref17","unstructured":"Generic peptide drugs. biosimilar pipeline. (2026). Accessed: 28 April 2026: https:\/\/www.peptidejournal.org\/news\/generic-peptide-drugs-biosimilar-pipeline."},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-020-02817-9","article-title":"Influence of production process and scale on quality of polypeptide drugs: a case study on GLP-1 analogs","volume":"37","author":"Staby A","year":"2020","unstructured":"Staby A, Steensgaard DB, Haselmann KF, et al.. Influence of production process and scale on quality of polypeptide drugs: a case study on GLP-1 analogs. Pharm Res. 2020, 37:120. 10.1007\/s11095-020-02817-9","journal-title":"Pharm Res"},{"key":"ref19","unstructured":"Citizen petition requesting regulatory action concerning compounded semaglutide preparations. (2025). Accessed. 20 March 2026: https:\/\/share.google\/obNePbbCaZiWNtD2q."},{"key":"ref20","unstructured":"Novo Nordisk - a focused healthcare company. investor presentation first three months of 2025. (2025). Accessed: 28 April 2026: https:\/\/www.novonordisk.com\/content\/dam\/nncorp\/global\/en\/investors\/pdfs\/financial-results\/2025\/Q1-2025-investor-prese...."},{"key":"ref21","unstructured":"Overweight and obesity management. (2026). Accessed. 20 March 2026: https:\/\/www.nice.org.uk\/guidance\/ng246\/chapter\/Identifying-and-assessing-overweight-obesity-and-central-adiposity."},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1007\/s12170-013-0329-6","article-title":"Race\/ethnicity, obesity, and related cardio-metabolic risk factors: a life-course perspective","volume":"7","author":"Wahi G","year":"2013","unstructured":"Wahi G, Anand SS. Race\/ethnicity, obesity, and related cardio-metabolic risk factors: a life-course perspective. Curr Cardiovasc Risk Rep. 2013, 7:326-35. 10.1007\/s12170-013-0329-6","journal-title":"Curr Cardiovasc Risk Rep"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(25)00164-0","article-title":"Once-weekly semaglutide 2\u00b74 mg in an Asian population with obesity, defined as BMI \u226525 kg\/m2, in South Korea and Thailand (STEP 11): a randomised, double-blind, placebo-controlled, phase 3 trial","volume":"13","author":"Lim S","year":"2025","unstructured":"Lim S, Buranapin S, Bao X, et al.. Once-weekly semaglutide 2\u00b74 mg in an Asian population with obesity, defined as BMI \u226525 kg\/m2, in South Korea and Thailand (STEP 11): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025, 13:838-47. 10.1016\/S2213-8587(25)00164-0","journal-title":"Lancet Diabetes Endocrinol"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(22)00008-0","article-title":"Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial","volume":"10","author":"Kadowaki T","year":"2022","unstructured":"Kadowaki T, Isendahl J, Khalid U, et al.. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2022, 10:193-206. 10.1016\/S2213-8587(22)00008-0","journal-title":"Lancet Diabetes Endocrinol"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2416394","article-title":"Tirzepatide as compared with semaglutide for the treatment of obesity","volume":"393","author":"Aronne LJ","year":"2025","unstructured":"Aronne LJ, Horn DB, le Roux CW, et al.. Tirzepatide as compared with semaglutide for the treatment of obesity. N Engl J Med. 2025, 393:26-36. 10.1056\/NEJMoa2416394","journal-title":"N Engl J Med"},{"key":"ref26","article-title":"Real-world evidence of injection semaglutide 2.4 mg in Indian adults with obesity: effects on weight loss and metabolic outcomes","volume":"13","author":"Shah R","year":"2026","unstructured":"Shah R, Unadkat V, Parekh M. Real-world evidence of injection semaglutide 2.4 mg in Indian adults with obesity: effects on weight loss and metabolic outcomes. Int J Sci Stud. 2026, 13:29-37.","journal-title":"Int J Sci Stud"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1016\/j.metop.2026.100460","article-title":"Efficacy and safety of semaglutide injection in comparison with reference semaglutide for chronic weight management in indian adults with obesity: a phase III randomized non-inferiority trial","volume":"30","author":"Sharma PK","year":"2026","unstructured":"Sharma PK, Redkar SV, Madhav Karmalkar A, et al.. Efficacy and safety of semaglutide injection in comparison with reference semaglutide for chronic weight management in indian adults with obesity: a phase III randomized non-inferiority trial. Metabol Open. 2026, 30:100460. 10.1016\/j.metop.2026.100460","journal-title":"Metabol Open"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.105749","article-title":"Comparative efficacy and safety of once-weekly semaglutide formulations in Indian adults with obesity: a phase III, randomized non-inferiority active-controlled study (size plus study)","volume":"18","author":"Kapoor N","year":"2026","unstructured":"Kapoor N, Kalra S, Naskar A, et al.. Comparative efficacy and safety of once-weekly semaglutide formulations in Indian adults with obesity: a phase III, randomized non-inferiority active-controlled study (size plus study). Cureus. 2026, 18:e105749. 10.7759\/cureus.105749","journal-title":"Cureus"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307563","article-title":"Semaglutide and cardiovascular outcomes in obesity without diabetes","volume":"389","author":"Lincoff AM","year":"2023","unstructured":"Lincoff AM, Brown-Frandsen K, Colhoun HM, et al.. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023, 389:2221-32. 10.1056\/NEJMoa2307563","journal-title":"N Engl J Med"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13955","article-title":"Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk","volume":"22","author":"Husain M","year":"2020","unstructured":"Husain M, Bain SC, Jeppesen OK, Lingvay I, S\u00f8rrig R, Treppendahl MB, Vilsb\u00f8ll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020, 22:442-51. 10.1111\/dom.13955","journal-title":"Diabetes Obes Metab"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-03133-0","article-title":"Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial","volume":"30","author":"Mann JF","year":"2024","unstructured":"Mann JF, Rossing P, Bakris G, et al.. Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial. Nat Med. 2024, 30:2849-56. 10.1038\/s41591-024-03133-0","journal-title":"Nat Med"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2403347","article-title":"Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes","volume":"391","author":"Perkovic V","year":"2024","unstructured":"Perkovic V, Tuttle KR, Rossing P, et al.. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. N Engl J Med. 2024, 391:109-21. 10.1056\/NEJMoa2403347","journal-title":"N Engl J Med"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2413258","article-title":"Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis","volume":"392","author":"Sanyal AJ","year":"2025","unstructured":"Sanyal AJ, Newsome PN, Kliers I, et al.. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. N Engl J Med. 2025, 392:2089-99. 10.1056\/NEJMoa2413258","journal-title":"N Engl J Med"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.3390\/ph18071075","article-title":"Semaglutide in MASLD patients: improved survival and liver outcomes","volume":"18","author":"Suki M","year":"2025","unstructured":"Suki M, Amer J, Milgrom Y, et al.. Semaglutide in MASLD patients: improved survival and liver outcomes. Pharmaceuticals (Basel). 2025, 18:1075. 10.3390\/ph18071075","journal-title":"Pharmaceuticals (Basel)"},{"key":"ref35","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14313","article-title":"Associations of semaglutide with first-time diagnosis of Alzheimer's disease in patients with type 2 diabetes: target trial emulation using nationwide real-world data in the US","volume":"20","author":"Wang W","year":"2024","unstructured":"Wang W, Wang Q, Qi X, et al.. Associations of semaglutide with first-time diagnosis of Alzheimer's disease in patients with type 2 diabetes: target trial emulation using nationwide real-world data in the US. Alzheimers Dement. 2024, 20:8661-72. 10.1002\/alz.14313","journal-title":"Alzheimers Dement"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2403664","article-title":"Once-weekly semaglutide in persons with obesity and knee osteoarthritis","volume":"391","author":"Bliddal H","year":"2024","unstructured":"Bliddal H, Bays H, Czernichow S, et al.. Once-weekly semaglutide in persons with obesity and knee osteoarthritis. N Engl J Med. 2024, 391:1573-83. 10.1056\/NEJMoa2403664","journal-title":"N Engl J Med"}],"container-title":["Cureus"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cureus.com\/articles\/488445-semaglutide-and-follow-on-peptide-therapeutics-balancing-innovation-regulation-and-clinical-outcomes","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T05:57:03Z","timestamp":1778997423000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cureus.com\/articles\/488445-semaglutide-and-follow-on-peptide-therapeutics-balancing-innovation-regulation-and-clinical-outcomes"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,16]]},"references-count":36,"URL":"https:\/\/doi.org\/10.7759\/cureus.108999","relation":{},"ISSN":["2168-8184"],"issn-type":[{"value":"2168-8184","type":"print"}],"subject":[],"published":{"date-parts":[[2026,5,16]]}}}