Biosimilars: Opinions, Reviews and Systematic Reviews

Articles (33 in this collection)

1. Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

   Authors (first, second and last of 4)

   • Hillel P. Cohen
   • Matthew Turner
   • Gillian R. Woollett

   • Content type: Current Opinion
   • Open Access
   • Published: 05 August 2023

   • Pages: 583 - 593

   

2. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022

   Authors (first, second and last of 5)

   • Ryosuke Kuribayashi
   • Ayuki Nakano
   • Futaba Honda

   • Content type: Leading Article
   • Published: 25 May 2023

   • Pages: 443 - 451

   

3. Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis

   Authors (first, second and last of 6)

   • HyeJung Na
   • Sun-Hong Kwon
   • Eui-Kyung Lee

   • Content type: Systematic Review
   • Published: 02 February 2023

   • Pages: 205 - 218

   

4. Copies of Biological Medicines: Similar But Not the Same?

   Authors

   • Pekka Kurki

   • Content type: Commentary
   • Open Access
   • Published: 30 January 2023

   • Pages: 123 - 126

5. Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies

   Authors (first, second and last of 6)

   • Hillel P. Cohen
   • Sohaib Hachaichi
   • Andrew Blauvelt

   • Content type: Systematic Review
   • Open Access
   • Published: 26 July 2022

   • Pages: 625 - 637

   

6. Pharmacists’ Perspectives of Biosimilars: A Systematic Review

   Authors (first, second and last of 4)

   • Noraisyah Mohd Sani
   • Zoriah Aziz
   • Adeeba Kamarulzaman

   • Content type: Systematic Review
   • Published: 01 July 2022

   • Pages: 489 - 508

   

7. Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One

   Authors (first, second and last of 9)

   • Joseph P. Park
   • Byoungin Jung
   • Gillian R. Woollett

   • Content type: Current Opinion
   • Open Access
   • Published: 13 June 2022

   • Pages: 431 - 436

8. Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience

   Authors (first, second and last of 6)

   • Pekka Kurki
   • Hye-Na Kang
   • Elena Wolff-Holz

   • Content type: Review Article
   • Open Access
   • Published: 21 May 2022

   • Pages: 359 - 371

   

9. Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review

   Authors (first, second and last of 4)

   • Rosanne W. Meijboom
   • Helga Gardarsdottir
   • Thijs J. Giezen

   • Content type: Systematic Review
   • Open Access
   • Published: 06 December 2021

   • Pages: 27 - 39

   

10. Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System

    Authors (first, second and last of 6)

    • Bharati Bhardwaja
    • Shilpa Klocke
    • Kari L. Olson

    • Content type: Leading Article
    • Published: 24 November 2021

    • Pages: 1 - 11

    

11. Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review

    Authors (first, second and last of 7)

    • Hanna M. Tolonen
    • Jenni Falck
    • Marja Airaksinen

    • Content type: Systematic Review
    • Open Access
    • Published: 16 August 2021

    • Pages: 547 - 561

    

12. Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

    Authors

    • Christopher J. Webster
    • Kelly L. George
    • Gillian R. Woollett

    • Content type: Current Opinion
    • Open Access
    • Published: 18 June 2021

    • Pages: 379 - 387

    

13. Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

    Authors (first, second and last of 5)

    • Daniel F. Alvarez
    • Gertjan Wolbink
    • Jonathan Kay

    • Content type: Review Article
    • Open Access
    • Published: 29 September 2020

    • Pages: 723 - 732

    

14. PF-06410293: An Adalimumab Biosimilar

    Authors

    • Arnold Lee
    • Matt Shirley

    • Content type: Adis Biosimilar Brief
    • Published: 19 September 2020

    • Pages: 695 - 698

    

15. The Importance of Countering Biosimilar Disparagement and Misinformation

    Authors

    • Hillel P. Cohen
    • Dorothy McCabe

    • Content type: Current Opinion
    • Open Access
    • Published: 20 July 2020

    • Pages: 407 - 414

16. Update on Biosimilar Insulins: A US Perspective

    Authors

    • Rong M. Zhang
    • Ritika Puri
    • Janet B. McGill

    • Content type: Review Article
    • Published: 17 July 2020

    • Pages: 505 - 512

    

17. The Path Towards a Tailored Clinical Biosimilar Development

    Authors (first, second and last of 9)

    • Martin Schiestl
    • Gopinath Ranganna
    • Julie Maréchal-Jamil

    • Content type: Review Article
    • Open Access
    • Published: 07 April 2020

    • Pages: 297 - 306

    

18. MYL1501D Insulin Glargine: A Review in Diabetes Mellitus

    Authors

    • Sheridan M. Hoy

    • Content type: Adis Drug Evaluation
    • Open Access
    • Published: 25 March 2020

    • Pages: 245 - 251

19. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

    Authors (first, second and last of 4)

    • Binita Dutta
    • Isabelle Huys
    • Steven Simoens

    • Content type: Review Article
    • Open Access
    • Published: 02 December 2019

    • Pages: 159 - 170

    

20. Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

    Authors (first, second and last of 6)

    • Vibeke Strand
    • Joao Gonçalves
    • John D. Isaacs

    • Content type: Review Article
    • Open Access
    • Published: 13 November 2019

    • Pages: 27 - 37

    

21. Delivering on the Promise of Biosimilars

    Authors

    • Arnold G. Vulto

    • Content type: Commentary
    • Published: 12 October 2019

    • Pages: 599 - 602

22. Evolution of the EU Biosimilar Framework: Past and Future

    Authors (first, second and last of 4)

    • Elena Wolff-Holz
    • Klara Tiitso
    • Martina Weise

    • Content type: Review Article
    • Open Access
    • Published: 20 September 2019

    • Pages: 621 - 634

23. Comparative Efficacy and Safety of Biosimilar Rituximab and Originator Rituximab in Rheumatoid Arthritis and Non-Hodgkin’s Lymphoma: A Systematic Review and Meta-analysis

    Authors

    • Soohyun Lee
    • Heeyoung Lee
    • EunYoung Kim

    • Content type: Systematic Review
    • Published: 24 August 2019

    • Pages: 469 - 483

    

24. Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

    Authors (first, second and last of 5)

    • Pere Gascon
    • Andriy Krendyukov
    • Matti Aapro

    • Content type: Review Article
    • Open Access
    • Published: 22 August 2019

    • Pages: 635 - 645

25. An Efficient Development Paradigm for Biosimilars

    Authors

    • Christopher J. Webster
    • Anny C. Wong
    • Gillian R. Woollett

    • Content type: Current Opinion
    • Open Access
    • Published: 06 August 2019

    • Pages: 603 - 611

    

26. Challenges in Post-marketing Studies of Biological Drugs in the Era of Biosimilars: A Report of the International Society for Pharmacoepidemiology 2019 Mid-Year Meeting in Rome, Italy

    Authors (first, second and last of 4)

    • Ylenia Ingrasciotta
    • Janet Sultana
    • Gianluca Trifirò

    • Content type: MEETING REPORT
    • Published: 16 July 2019

    • Pages: 345 - 352

27. Biosimilars: A Value Proposition

    Authors

    • Fernando de Mora

    • Content type: Current Opinion
    • Published: 07 June 2019

    • Pages: 353 - 356

28. Efficacy and Safety of Anti-cancer Biosimilars Compared to Reference Biologics in Oncology: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Authors (first, second and last of 11)

    • Jichun Yang
    • Shuqing Yu
    • Feng Sun

    • Content type: Systematic Review
    • Published: 07 June 2019

    • Pages: 357 - 371

    

29. Efficacy and Safety of Supportive Care Biosimilars Among Cancer Patients: A Systematic Review and Meta-Analysis

    Authors (first, second and last of 11)

    • Jichun Yang
    • Shuqing Yu
    • Feng Sun

    • Content type: Systematic Review
    • Published: 03 June 2019

    • Pages: 373 - 389

    

30. Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence

    Authors (first, second and last of 4)

    • Salvatore Bellinvia
    • J. R. Fraser Cummings
    • Christopher J. Edwards

    • Content type: Leading Article
    • Published: 20 May 2019

    • Pages: 241 - 253

31. LA-EP2006: A Pegfilgrastim Biosimilar

    Authors

    • Sheridan M. Hoy

    • Content type: Adis Biosimilar Brief
    • Published: 18 March 2019

    • Pages: 229 - 232

    

32. FKB327: An Adalimumab Biosimilar

    Authors

    • Zaina T. Al-Salama

    • Content type: Adis Biosimilar Brief
    • Published: 02 February 2019

    • Pages: 113 - 116

    

33. Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar

    Authors

    • Sheridan M. Hoy

    • Content type: Adis Biosimilar Brief
    • Published: 30 January 2019

    • Pages: 117 - 120