Expert Opinion on Biological Therapy最新文献

{"title":"An evaluation of patritumab deruxtecan for the treatment of <i>EGFR</i>-mutated non-small cell lung cancer.","authors":"Barliz Waissengrin, Karen L Reckamp","doi":"10.1080/14712598.2025.2507833","DOIUrl":"10.1080/14712598.2025.2507833","url":null,"abstract":"<p><strong>Introduction: </strong>Epidermal growth factor receptor (EGFR) mutations represent targetable alterations in non-small cell lung cancer (NSCLC). The treatment landscape in the frontline setting for patients with advanced <i>EGFR</i>-mutated NSCLC is evolving with increasing treatment options. EGFR tyrosine kinase inhibitors (TKIs) have significantly improved outcomes, but resistance inevitably develops, necessitating alternative strategies.</p><p><strong>Areas covered: </strong>Patritumab deruxtecan is a novel antibody-drug conjugate targeted human epidermal growth factor receptor-3 (HER3), delivering a topoisomerase-I inhibitor payload to HER3-expressing cancer cells. Phase I and II studies have demonstrated efficacy in patients with <i>EGFR</i>-mutant NSCLC with disease progression after prior therapies, including third-generation EGFR TKIs and platinum-based chemotherapy. The phase-II trial reported an objective response rate of 39% and a median progression-free survival of 5.5 months. Patritumab deruxtecan is associated with notable toxicities, including grade 3 and higher hematologic adverse events, gastrointestinal toxicity, and interstitial lung disease (ILD). ILD occurred in 5.3% of patients in the Phase-II study. Early detection and management are crucial for minimizing the risk of complications.</p><p><strong>Expert opinion: </strong>Patients with advanced EGFR-mutant NSCLC who have received TKI therapy and chemotherapy have limited treatment options. Patritumab deruxtecan demonstrates clinical activity in this population with manageable side effects, addressing an unmet need for patients.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"583-591"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perspectives on the de-escalation of anti-CD20 monoclonal antibodies in patients with multiple sclerosis.","authors":"Abdorreza Naser Moghadasi","doi":"10.1080/14712598.2025.2501730","DOIUrl":"10.1080/14712598.2025.2501730","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"569-572"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The potential role of biosimilars in healthcare sustainability in Latin America.","authors":"Rony Schaffel, Paul Cornes, Manuel A Espinoza, David Gómez-Almaguer, Angelo Maiolino, Daniel Freire, Tobias Foierl","doi":"10.1080/14712598.2025.2507173","DOIUrl":"10.1080/14712598.2025.2507173","url":null,"abstract":"<p><strong>Introduction: </strong>Latin American (LatAm) countries face significant increases in healthcare expenditure, driven largely by population growth and aging, and the rising prevalence of cancer and other chronic diseases. Growing demand and high costs of biologic medicines present barriers to patient access in this region. Biosimilars can improve the affordability and accessibility of biologics, supporting long-term healthcare sustainability. However, their uptake in LatAm has generally been slow.</p><p><strong>Areas covered: </strong>Challenges and barriers to the use of biosimilars and potential strategies to increase biosimilar uptake in LatAm, drawing on learnings from Europe and the U.S.A.</p><p><strong>Expert opinion: </strong>Potential initiatives to drive biosimilar uptake across LatAm include (1) harmonized regulatory processes for biosimilars, with reimbursement policies that prioritize their use and incentives to encourage prescribing; (2) education for key stakeholders to limit misinformation about biosimilars, provide reassurance about safety and efficacy, and increase understanding and acceptance; (3) simplified health technology assessment processes for biosimilars that expedite or adapt some aspects of the traditional approach; and (4) coordinated regional efforts to enable national healthcare systems to purchase medicines in the most cost-effective way, with value frameworks to support decision-making and the implementation of centralized purchasing, competition policies, and risk-sharing agreements.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"633-647"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Second-line strategies after anti-TNF failure in chronically active, moderate-to-severe ulcerative colitis: a retrospective, multicentre cohort study.","authors":"Bernadett Farkas, Jimmy K Limdi, Péter Bacsur, Edoardo Vincenzo Savarino, Luisa Bertin, Karishma Sethi-Arora, Pál Miheller, Fruzsina Vilmos, Fabiana Castiglione, Livio Bonacci, Milan Lukas, Nitsan Maharshak, Galia Berman, Željko Krznaric, Panu Wetwittayakhlang, Peter L Lakatos, Jakob Benedict Seidelin, Mohamed Attauabi, George Michalopoulos, Davide Giuseppe Ribaldone, Anna Kagramanova, Elena Chashkova, Patrícia Sarlós, Simone Saibeni, Ariella Bar-Gil Shitrit, Mariann Borsos, Tamás Resál, Zoltán Szepes, Tamás Molnár, Klaudia Farkas","doi":"10.1080/14712598.2025.2500962","DOIUrl":"10.1080/14712598.2025.2500962","url":null,"abstract":"<p><strong>Background: </strong>Many ulcerative colitis (UC) patients require the use of second-line agents after the failure of anti-TNF therapy.</p><p><strong>Research design and methods: </strong>We conducted a multicenter, retrospective study including 683 chronically active, moderate-to-severe UC patients who failed first-line anti-TNFs. The rate of treatment persistence and colectomy-free survival was assessed up to 3 years after the initiation of second-line therapy. Predictors for colectomy and persistence were investigated.</p><p><strong>Results: </strong>After the failure of the first-line anti-TNF, ustekinumab had superior persistence and colectomy-free survival rates compared to tofacitinib (<i>p</i> = 0.05; <i>p</i> = 0.001) and vedolizumab (<i>p</i> = 0.02; <i>p</i> = 0.05), but significant difference was only found in persistence rates in comparison with anti-TNFs (<i>p</i> < 0.001). Regardless of the number of prior anti-TNFs, significantly higher persistence (<i>p</i> = 0.05) and colectomy-free survival rates (<i>p</i> = 0.01) were observed over 2 years with ustekinumab than with vedolizumab or tofacitinib, whereas ustekinumab's superiority over tofacitinib seemed to disappear by the third year. Hypoalbuminaemia (<i>p</i> = 0.002) and shorter disease duration at second-line initiation (<i>p</i> = 0.03) increased, while concomitant immunomodulators (<i>p</i> = 0.05) reduced the risk for colectomy. Shorter disease duration (<i>p</i> = 0.01) and primary non-response to the previously used anti-TNF (<i>p</i> < 0.001) negatively influenced persistence with second-line non-TNF-targeted agents.</p><p><strong>Conclusion: </strong>After first-line anti-TNF failure, switching to a non-anti-TNF agent is worth considering in moderate-to-severe UC.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"669-678"},"PeriodicalIF":4.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"With guselkumab, does the dual mechanisms to inhibit IL-23, help in ulcerative colitis?","authors":"Sheila A Doggrell","doi":"10.1080/14712598.2025.2508836","DOIUrl":"10.1080/14712598.2025.2508836","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcerative colitis (UC) includes a dysregulated immune response. The conventional therapy includes immunosuppressants, and biologics targeting inflammatory mediators, but these are often inadequate, or subjects become unable to tolerate them.</p><p><strong>Areas covered: </strong>QUASAR: the induction and maintenance components of the phase 3 trial of guselkumab, which inhibits IL-23 by dual mechanisms, in subjects with moderate-to-severe UC. QUASAR enrolled those that had an inadequate response and/or intolerance to corticosteroids, immunosuppressants, biologics, or Janus kinase (JAK) inhibitors. In both parts of the trial, guselkumab improved clinical remission with no excess of adverse events.</p><p><strong>Expert opinion: </strong>For those enrolled throughout, after the maintenance part, the benefit with guselkumab on clinical remission was 24% percentage points (45 vs 21%), which is relatively small. There is no direct comparison of guselkumab with other IL-23 inhibitors in UC. Indirectly comparing trials suggests the clinical remission rates at the end of the trials was higher with guselkumab than with the other approved IL-23, inhibitors, mirikizumab or risankizumab (17 or 15% points, respectively). Thus, guselkumab may be more efficacious than the other 1 L-23 antagonists, possibly due to its additional action to block the CD64 receptor. However, this needs to be tested in a direct comparison trial.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"593-598"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evolving global regulatory landscape for approval of biosimilars: current challenges and opportunities for convergence.","authors":"Elif Car, Liese Barbier, Isabelle Huys, Steven Simoens, Arnold G Vulto","doi":"10.1080/14712598.2025.2507832","DOIUrl":"10.1080/14712598.2025.2507832","url":null,"abstract":"<p><strong>Introduction: </strong>Biosimilars promote price competition, improving affordability and access to biologics without compromising on quality, efficacy, and safety. Biosimilar approvals initially followed a cautious approach, with regulatory requirements developed independently across jurisdictions, complicating global development and increasing costs. Advancements in analytical sciences and two decades of accumulated experience with biosimilar approvals offer an opportunity to reevaluate regulatory requirements.</p><p><strong>Areas covered: </strong>A structured literature review was conducted using PubMed, Embase, and Web of Science, to identify challenges related to biosimilarity demonstration, offer a comprehensive understanding of regulatory requirements for biosimilars globally, and identify opportunities for regulatory convergence. Following title, abstract, and full-text screening, 61 articles were included.</p><p><strong>Expert opinion: </strong>Biosimilar guidelines from stringent regulatory authorities such as EMA and USFDA are robust, yet further alignment of regulatory standards in the US and EU is possible to reflect scientific progress and clinical experience. Regulatory requirements for biosimilars in emerging markets appear to be disproportionate to scientific advancements and accumulated knowledge with biosimilars approval and clinical experience. Global harmonization of biosimilar guidelines, based on gained developments and regulatory experience, could accelerate development and approval process. This would facilitate earlier and enhanced access to safe and affordable biologics.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"649-668"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review on recommendations on the use of biologic therapy for the management of moderate-severe psoriasis in Saudi Arabia: an expert opinion.","authors":"Mohammed Fatani, Abdullah Aldugaither, Mufaddal Alaithan, Amaal Alruwaili, Sultan Mubarki, Mohammed Alajlan, Yousef Binamer, Aymen Alharbi, Bedor AlOmari, Issam Hamada","doi":"10.1080/14712598.2025.2495986","DOIUrl":"10.1080/14712598.2025.2495986","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic inflammatory skin disorder with a significant global burden, impacting patients both physically and psychologically. While its exact etiology remains unclear, genetic predisposition and environmental triggers play key roles.</p><p><strong>Areas covered: </strong>Biologic therapies have revolutionized psoriasis management, offering targeted and effective disease control. However, despite their proven benefits, these treatments remain underutilized, limiting optimal outcomes and contributing to disparities in care. This expert consensus examines current challenges in biologics use and provides evidence-based recommendations for managing moderate-to-severe psoriasis in Saudi Arabia.</p><p><strong>Expert opinion: </strong>Optimizing biologic therapy use is crucial for improving patient outcomes and reducing disease burden. By addressing gaps in clinical practice, this consensus aims to streamline management approaches and reduce treatment disparities in Saudi Arabia.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"599-606"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 'totality of evidence' and 'extrapolation' of SB17, a ustekinumab biosimilar.","authors":"Jae Hee Cheon, Byong Duk Ye, Alessandro Armuzzi, Florian Rieder, Giampiero Girolomoni, Luis Puig, Hojung Jung, Steven R Feldman","doi":"10.1080/14712598.2025.2508838","DOIUrl":"10.1080/14712598.2025.2508838","url":null,"abstract":"<p><strong>Introduction: </strong>SB17 is a ustekinumab (UST) biosimilar targeting interleukin-12/23 for treating immune-mediated inflammatory diseases (IMIDs). The development of UST biosimilars like SB17 may help address the high cost of innovator biologics, offering affordable alternatives without compromising efficacy or safety.</p><p><strong>Areas covered: </strong>This review encompasses the totality of evidence supporting SB17's similarity to UST, its regulatory approval, and indication extrapolation. It also discusses SB17's lower immunogenicity relative to UST.</p><p><strong>Expert opinion: </strong>The approval of UST biosimilars represents a significant advancement in managing chronic IMIDs including psoriasis, plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, providing cost-effective, efficacious alternatives. A randomized double-blind 28-week study involving over 500 patients with moderate-to-severe chronic plaque psoriasis demonstrated SB17's equivalence to UST, with more than 80% of patients achieving over 90% improvement in psoriasis severity indices. Treatment-emergent adverse events were comparable between SB17 and UST. Despite their potential to transform clinical outcomes, economic burdens, and drug utilization patterns, the adoption of UST biosimilars faces challenges, including concerns about equivalence and regulatory inconsistencies. Addressing these issues through education, consistent regulatory frameworks, real-world data, and ongoing monitoring is crucial for their successful integration into clinical practice.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"615-632"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Autoimmune neuro-ophthalmic disorders: pathophysiologic mechanisms and targeted biologic therapies.","authors":"Lucas W Rowe, Zachary R Barry, Devin D Mackay, Kevin E Lai, Thomas A Ciulla","doi":"10.1080/14712598.2025.2491603","DOIUrl":"https://doi.org/10.1080/14712598.2025.2491603","url":null,"abstract":"<p><strong>Introduction: </strong>Autoimmune neuro-ophthalmic disorders encompass a diverse array of conditions, including thyroid eye disease (TED), myasthenia gravis (MG), optic neuropathy due to giant cell arteritis (GCA), and optic neuritis related to multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). While traditional treatments have shown efficacy in managing symptoms, the rapid emergence of biologic therapies has brought forth new avenues for targeted intervention, revolutionizing treatment approaches for these conditions.</p><p><strong>Areas covered: </strong>This review highlights the pathophysiologic pathways and FDA-approved biologic therapies utilized in the management of autoimmune neuro-ophthalmic disorders. We explore multiple therapeutic approaches for autoimmune neuro-ophthalmic disorders, including IGF-1 R antagonism, IL-6 inhibition, complement inhibition, FcRn targeting, B-cell depletion and T-cell modulation. Literature from clinical trials, observational studies, and meta-analyses through 2024 was evaluated to assess efficacy, safety, and long-term outcomes.</p><p><strong>Expert opinion: </strong>Biologic therapies represent a significant advancement in autoimmune neuro-ophthalmic disorders, offering targeted approaches with improved efficacy and safety profiles compared to traditional treatments. Ongoing developments in biomarker identification and delivery systems suggest an increasingly personalized approach to treatment. Future advances will likely focus on optimizing patient selection, reducing costs, improving accessibility, and developing novel therapeutic targets.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":"25 5","pages":"1-22"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ivonescimab in non-small cell lung cancer: harmonizing immunotherapy and anti-angiogenesis.","authors":"Yan Zhang, Xinyu Liu, Shengxiang Ren","doi":"10.1080/14712598.2025.2487512","DOIUrl":"10.1080/14712598.2025.2487512","url":null,"abstract":"<p><strong>Introduction: </strong>Immunotherapy combined with anti-angiogenesis has become a useful strategy in cancer treatment. Ivonescimab, the first-approved bispecific antibody targeting both immune checkpoint inhibition and anti-angiogenesis, represents a breakthrough over the conventional dual-drug combination approach. The emerging clinical evidence demonstrates promising efficacy and manageable safety profile of ivonescimab in the treatment of non-small cell lung cancer (NSCLC), suggesting its potential role as a cornerstone in the next generation of cancer immunotherapy.</p><p><strong>Areas covered: </strong>This review presents the pharmacological characteristics of ivonescimab, revisits relevant clinical trials and key data, and provides an in-depth analysis. Additionally, the potential of ivonescimab in NSCLC treatment is discussed, along with its clinical prospects.</p><p><strong>Expert opinion: </strong>The available clinical data demonstrate that simultaneously targeting both immune checkpoint inhibition and angiogenesis pathways through a single bispecific antibody represents a significant therapeutic advancement in NSCLC treatment. Ivonescimab's innovative dual-targeting mechanism, supported by promising efficacy data from the HARMONi trials and its manageable safety profile, appears to be fundamental to its potential to challenge current standards of care. As the first approved bispecific antibody with this unique mechanism of action, ivonescimab may not only transform current treatment paradigms but also pioneer a new direction in cancer immunotherapy.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-7"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}