Expert opinion on biological therapy

Keyphrases

Publications

volume 24, number 7, 2024

Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease. Expert opinion on biological therapy 24 (7) (2024)
Ahmad Z Al Meslamani
Short and long-term economic implications of biosimilars. Expert opinion on biological therapy 24 (7) (2024)
Thomas W J Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn, Claudio Romano
Infliximab biosimilar GP1111: a review of 5 years' post-approval experience. Expert opinion on biological therapy 24 (7) (2024)
Thomas W J Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn, Claudio Romano
Infliximab biosimilar GP1111: a review of 5 years' post-approval experience. Expert opinion on biological therapy 24 (7) (2024)
Heather Rae Hufnagel, Scott D Tennyson
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. Expert opinion on biological therapy 24 (7) (2024)
Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease. Expert opinion on biological therapy 24 (7) (2024)
Isabel Río-Álvarez, Encarnación Cruz-Martos
Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market. Expert opinion on biological therapy 24 (7) (2024)
Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl, Dorothy McCabe
Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF). Expert opinion on biological therapy 24 (7) (2024)
Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, Min-Kyu Park, Jun Gi Hwang, Seol Ju Moon, Min Gul Kim, Edward C Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee, Gerd R Burmester
Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study. Expert opinion on biological therapy 24 (7) (2024)
Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu, Weibo Xia
Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert opinion on biological therapy 24 (7) (2024)
Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, Min-Kyu Park, Jun Gi Hwang, Seol Ju Moon, Min Gul Kim, Edward C Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee, Gerd R Burmester
Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study. Expert opinion on biological therapy 24 (7) (2024)
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
Examining the impact of biosimilar-to-biosimilar transition on effectiveness and safety. Expert opinion on biological therapy 24 (7) (2024)
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
Examining the impact of biosimilar-to-biosimilar transition on effectiveness and safety. Expert opinion on biological therapy 24 (7) (2024)
Tsz Ching Mok, Chi Chiu Mok
Non-TNF biologics and their biosimilars in rheumatoid arthritis. Expert opinion on biological therapy 24 (7) (2024)
Cecil Nick
Streamlining biosimilar development based on 20 years' experience. Expert opinion on biological therapy 24 (7) (2024)
Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. Expert opinion on biological therapy 24 (7) (2024)
Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. Expert opinion on biological therapy 24 (7) (2024)
Anhye Kim, Jang-Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee, Stuart L Silverman
A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males. Expert opinion on biological therapy 24 (7) (2024)
Heather Rae Hufnagel, Scott D Tennyson
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. Expert opinion on biological therapy 24 (7) (2024)
Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu, Weibo Xia
Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert opinion on biological therapy 24 (7) (2024)
Tsz Ching Mok, Chi Chiu Mok
Non-TNF biologics and their biosimilars in rheumatoid arthritis. Expert opinion on biological therapy 24 (7) (2024)
Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega
Biosimilars and access to biologic therapy in immune-mediated diseases. Expert opinion on biological therapy 24 (7) (2024)
Isabel Río-Álvarez, Encarnación Cruz-Martos
Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market. Expert opinion on biological therapy 24 (7) (2024)
Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl, Dorothy McCabe
Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF). Expert opinion on biological therapy 24 (7) (2024)
Anhye Kim, Jang-Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee, Stuart L Silverman
A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males. Expert opinion on biological therapy 24 (7) (2024)
Heather Rae Hufnagel, Scott D Tennyson
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. Expert opinion on biological therapy 24 (7) (2024)
Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease. Expert opinion on biological therapy 24 (7) (2024)
Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, Min-Kyu Park, Jun Gi Hwang, Seol Ju Moon, Min Gul Kim, Edward C Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee, Gerd R Burmester
Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study. Expert opinion on biological therapy 24 (7) (2024)
Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. Expert opinion on biological therapy 24 (7) (2024)
Thomas W J Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn, Claudio Romano
Infliximab biosimilar GP1111: a review of 5 years' post-approval experience. Expert opinion on biological therapy 24 (7) (2024)
Tsz Ching Mok, Chi Chiu Mok
Non-TNF biologics and their biosimilars in rheumatoid arthritis. Expert opinion on biological therapy 24 (7) (2024)
Ahmad Z Al Meslamani
Short and long-term economic implications of biosimilars. Expert opinion on biological therapy 24 (7) (2024)
Isabel Río-Álvarez, Encarnación Cruz-Martos
Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market. Expert opinion on biological therapy 24 (7) (2024)
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
Examining the impact of biosimilar-to-biosimilar transition on effectiveness and safety. Expert opinion on biological therapy 24 (7) (2024)
Ahmad Z Al Meslamani
Short and long-term economic implications of biosimilars. Expert opinion on biological therapy 24 (7) (2024)

volume 24, number 8, 2024

Lucas W Rowe, Thomas A Ciulla
Long-acting delivery and therapies for neovascular age-related macular degeneration. Expert opinion on biological therapy 24 (8) (2024)
Arturo Casadevall, Scott McConnell, Daniele Focosi
Considerations for the development of monoclonal antibodies to address new viral variants in COVID-19. Expert opinion on biological therapy 24 (8) (2024)
Elizaveta Kon, Giuseppe Anzillotti, Pietro Conte, Luca Ruosi, Brian Cole, Jason Dragoo, Ken Zaslav, Rachel Frank, Laura De Girolamo, Bert Mandelbaum, Scott Rodeo, Maurilio Marcacci, Giuseppe Filardo, Berardo Di Matteo
The chimera of reaching a universal consensus on platelet-rich plasma treatment for knee osteoarthritis: a review of recent consensus statements and expert opinion. Expert opinion on biological therapy 24 (8) (2024)
Daniel R Reed, Lawrence G Lum
Looking ahead to CD3, T-cell engager bispecific antibodies for hematological malignancies. Expert opinion on biological therapy 24 (8) (2024)
Giuseppe Lopalco, Andrea Cito, Vincenzo Venerito, Florenzo Iannone, Fabian Proft
The management of axial spondyloarthritis with cutting-edge therapies: advancements and innovations. Expert opinion on biological therapy 24 (8) (2024)
Ramazan Emre Yiğit, Kadir Ulu, Şengül Çağlayan, Betul Sozeri
Real-life data of etanercept efficacy and safety in juvenile idiopathic arthritis: a 24-month retrospective study at a single center. Expert opinion on biological therapy 24 (8) (2024)
Luca Mastorino, Irene Richiardi, Federica Gelato, Giovanni Cavaliere, Pietro Quaglino, Michela Ortoncelli, Simone Ribero
Predisposition to conjunctivitis and male sex reduces drug survival of dupilumab in adults and adolescents. Expert opinion on biological therapy 24 (8) (2024)
Virginia E Fontenot, Alex Francoeur, Krishnansu S Tewari
Review of emerging biological therapies for recurrent and advanced metastatic cervical cancer. Expert opinion on biological therapy 24 (8) (2024)
Francesco Caso, Mauro Fatica, Mario Ferraioli, Matteo Megna, Luca Potestio, Angelo Ruggiero, Nello Tommasino, Francesco Maione, Raffaele Scarpa, Maria Sole Chimenti, Luisa Costa
The role of bDMARDs in the prevention and treatment of inflammatory-related comorbidities in Psoriatic Arthritis. Expert opinion on biological therapy 24 (8) (2024)
Mohammad Shehab, Davide De Marco, Peter L Lakatos, Talat Bessissow
The potential for medical therapies to address fistulizing Crohn's disease: a state-of-the-art review. Expert opinion on biological therapy 24 (8) (2024)
Bingquan Wu, Chao Quan, Yunbo He, Juliet Matsika, Jinliang Huang, Bolong Liu, Jinbo Chen
Targeting gut and intratumoral microbiota: a novel strategy to improve therapy resistance in cancer with a focus on urologic tumors. Expert opinion on biological therapy 24 (8) (2024)
Daniel R Reed, Lawrence G Lum
Looking ahead to CD3, T-cell engager bispecific antibodies for hematological malignancies. Expert opinion on biological therapy 24 (8) (2024)
Aliki I Venetsanopoulou, Paraskevi V Voulgari, Alexandros A Drosos
Optimizing withdrawal strategies for anti-TNF-α therapies in rheumatoid arthritis. Expert opinion on biological therapy 24 (8) (2024)
Shinichi Kumagai, Takeshi Nakajima, Shin-Ichi Muramatsu
Intraparenchymal delivery of adeno-associated virus vectors for the gene therapy of neurological diseases. Expert opinion on biological therapy 24 (8) (2024)
Rubén Queiro, Sara Alonso, Jose A Pinto-Tasende
The nail in psoriatic arthritis: new insights into prognosis and treatment. Expert opinion on biological therapy 24 (8) (2024)