biosimilar pharmaceuticals


Summary: BIOLOGIC PRODUCTS that are imitations but not exact replicas of innovator products.

Top Publications

  1. Mesgarpour B, Heidinger B, Roth D, Schmitz S, Walsh C, Herkner H. Harms of off-label erythropoiesis-stimulating agents for critically ill people. Cochrane Database Syst Rev. 2017;8:CD010969 pubmed publisher
    ..Most studies neither evaluated ESAs' harm as a primary outcome nor predefined adverse events. Any further studies of ESA should address the quality of evaluating, recording and reporting of adverse events. ..
  2. Jørgensen K, Olsen I, Goll G, Lorentzen M, Bolstad N, Haavardsholm E, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304-2316 pubmed publisher
    ..The study was not powered to show non-inferiority in individual diseases. Norwegian Ministry of Health and Care Services. ..
  3. Cohen S, Genovese M, Choy E, Perez Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017;76:1679-1687 pubmed publisher
    ..Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. ..
  4. Balint A, Rutka M, Végh Z, Kürti Z, Gecse K, Banai J, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort. Expert Opin Drug Saf. 2017;16:885-890 pubmed publisher
    ..Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions. ..
  5. Smolen J, Choe J, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology (Oxford). 2017;56:1771-1779 pubmed publisher
    ..Radiographic progression was comparable at 1 year. (; NCT01936181) and EudraCT (; 2012-005733-37). ..
  6. Gronde T, Uyl de Groot C, Pieters T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS ONE. 2017;12:e0182613 pubmed publisher
    ..There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines. ..
  7. Mastrangeli R, Satwekar A, Cutillo F, Ciampolillo C, Palinsky W, Longobardi S. In-vivo biological activity and glycosylation analysis of a biosimilar recombinant human follicle-stimulating hormone product (Bemfola) compared with its reference medicinal product (GONAL-f). PLoS ONE. 2017;12:e0184139 pubmed publisher
    ..The clinical relevance of the differences observed between GONAL-f and Bemfola should be further investigated. ..
  8. Declerck P, Farouk Rezk M. The road from development to approval: evaluating the body of evidence to confirm biosimilarity. Rheumatology (Oxford). 2017;56:iv4-iv13 pubmed publisher
    ..The role of these agents in rheumatology will be determined by the confidence placed in them by rheumatologists. These prescribers should expect high-quality data evaluated by an extensive assessment process. ..
  9. Ogura M, Coiffier B, Kwon H, Yoon S. Scientific rationale for extrapolation of biosimilar data across cancer indications: case study of CT-P10. Future Oncol. 2017;13:45-53 pubmed publisher
    ..Here, we review the scientific rationale for extrapolation in biosimilar development using the example of CT-P10 as a case study. ..

More Information


  1. Uhlig T, Goll G. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford). 2017;56:iv49-iv62 pubmed publisher
    ..Additional ongoing studies and registries may help to optimize the process of switching, and different funding models are examining the optimal mechanisms to ensure effective uptake of these new treatments. ..
  2. Li E, Liu J, Ramchandani M. A Framework for Integrating Biosimilars Into the Didactic Core Requirements of a Doctor of Pharmacy Curriculum. Am J Pharm Educ. 2017;81:57 pubmed publisher
  3. Mantravadi S, Ogdie A, Kraft W. Tumor necrosis factor inhibitors in psoriatic arthritis. Expert Rev Clin Pharmacol. 2017;10:899-910 pubmed publisher
  4. Hettema W, Wynne C, Lang B, Altendorfer M, Czeloth N, Lohmann R, et al. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Expert Opin Investig Drugs. 2017;26:889-896 pubmed publisher
    ..Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087. ..
  5. Kim W, Ogura M, Kwon H, Choi D. Looking to the future and learning lessons from the recent past: changing stakeholder perceptions of biosimilars in cancer. Future Oncol. 2017;13:17-29 pubmed publisher
    ..We discuss these considerations and refer to recent experiences with CT-P13, a biosimilar of the TNF inhibitor infliximab used to treat rheumatoid arthritis and other inflammatory disorders. ..
  6. Camacho L. Current Status of Biosimilars in Oncology. Drugs. 2017;77:985-997 pubmed publisher
  7. Kibble A. Evidence Europe 2017. London, UK - February 22-23, 2017. Drugs Today (Barc). 2017;53:203-207 pubmed publisher
    ..With a particular focus on real-world evidence, the conference used presentations, panel briefings and roundtable discussions to foster debate on the challenges faced by industry as it negotiates the current fragile environment. ..
  8. Monheit G, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017;37:S4-S11 pubmed publisher
    ..This review focuses on the history of Dysport to mark the 25th anniversary of its first launch in the United Kingdom. ..
  9. Miao S, Fan L, Zhao L, Ding D, Liu X, Wang H, et al. Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab. Biomed Res Int. 2017;2017:4926168 pubmed publisher
    ..Taken together, HS628 can be considered as a highly similar molecule to originator tocilizumab in terms of physicochemical and biological properties. ..
  10. Jones G, Nash P, Hall S. Advances in rheumatoid arthritis. Med J Aust. 2017;206:221-224 pubmed
    ..While there is no cure for rheumatoid arthritis, treatment has improved to the point where many patients can achieve a normal quality of life. ..
  11. Smolen J, Cohen S, Tony H, Scheinberg M, Kivitz A, Balanescu A, et al. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017;76:1598-1602 pubmed publisher
    ..Three-way PK/PD equivalence of GP2013, RTX-EU and RTX-US was demonstrated. Efficacy, safety and immunogenicity profiles were similar between GP2013 and RTX. NCT01274182; Results. ..
  12. Inotai A, Prins C, Csanádi M, Vitezic D, Codreanu C, Kalo Z. Is there a reason for concern or is it just hype? - A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opin Biol Ther. 2017;17:915-926 pubmed publisher
    ..Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped. ..
  13. Smits L, Grelack A, Derikx L, de Jong D, van Esch A, Boshuizen R, et al. Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease. Dig Dis Sci. 2017;62:3117-3122 pubmed publisher
    ..These 1-year data suggest that switching to CT-P13 in Remicade®-treated IBD patients is safe and feasible. ..
  14. Lisenko K, Baertsch M, Meiser R, Pavel P, Bruckner T, Kriegsmann M, et al. Comparison of biosimilar filgrastim, originator filgrastim, and lenograstim for autologous stem cell mobilization in patients with multiple myeloma. Transfusion. 2017;57:2359-2365 pubmed publisher
  15. Buske C, Ogura M, Kwon H, Yoon S. An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements. Future Oncol. 2017;13:5-16 pubmed publisher
    ..The path to approval is discussed with reference to the rituximab biosimilar CT-P10, the first licensed monoclonal antibody biosimilar cancer therapeutic. ..
  16. Kirchhoff C, Wang X, Conlon H, Anderson S, Ryan A, Bose A. Biosimilars: Key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114:2696-2705 pubmed publisher
    ..This review discusses the challenges faced by pharmaceutical companies in the development of biosimilars...
  17. Schulze Koops H, Skapenko A. Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm. Rheumatology (Oxford). 2017;56:iv30-iv48 pubmed publisher
    ..The introduction of biosimilar bDMARDs has the potential to improve patient access to effective biologic therapy, to better accommodate restraints within healthcare budgets and to improve overall patient outcomes. ..
  18. Portela M, Sinogas C, Albuquerque de Almeida F, Baptista Leite R, Castro Caldas A. Biologicals and biosimilars: safety issues in Europe. Expert Opin Biol Ther. 2017;17:871-877 pubmed publisher
    ..It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure. ..
  19. Kim W, Coiffier B, Kwon H, Kim S. Clinical development of CT-P10 and other biosimilar cancer therapeutics. Future Oncol. 2017;13:31-44 pubmed publisher
    ..Trials of biosimilar cancer therapeutics in development are also discussed. ..
  20. Glintborg B, Sørensen I, Loft A, Lindegaard H, Linauskas A, Hendricks O, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76:1426-1431 pubmed publisher
    ..Adjusted 1-year CT-P13 retention rate was slightly lower than for INX in a historic cohort. ..
  21. Declerck P, Danesi R, Petersel D, Jacobs I. The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. Drugs. 2017;77:671-677 pubmed publisher
    ..Extrapolation of data may be used to grant approval of biosimilars in indications not directly evaluated in clinical studies using the biosimilar. ..
  22. Lexchin J. Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study. Value Health. 2017;20:1139-1142 pubmed publisher
    ..Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. ..
  23. Fernandes G, Sternberg C, Lopes G, Chammas R, Gifoni M, Gil R, et al. The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC). Braz J Med Biol Res. 2018;51:e7214 pubmed publisher
    ..We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society. ..
  24. Vulto A, Jaquez O. The process defines the product: what really matters in biosimilar design and production?. Rheumatology (Oxford). 2017;56:iv14-iv29 pubmed publisher
  25. Patel D, Gillis C, Naggar J, Mistry A, Mantzoros C. The rise of biosimilars: How they got here and where they are going. Metabolism. 2017;75:45-53 pubmed publisher
    ..This article introduces the concept of a biosimilar, discusses the regulatory process in the United States, and reviews the risks and benefits of these products. ..
  26. Zelenetz A, Ahmed I, Braud E, Cross J, Davenport Ennis N, Dickinson B, et al. NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9 Suppl 4:S1-22 pubmed
  27. Coiffier B. Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10. Expert Rev Clin Pharmacol. 2017;10:923-933 pubmed publisher
    ..Approved in all indications held by RTX, CT-P10 has the potential to reduce treatment costs and thereby increase patient access to rituximab therapy. ..
  28. Jamshidi A, Gharibdoost F, Vojdanian M, Soroosh S, Soroush M, Ahmadzadeh A, et al. A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid. Arthritis Res Ther. 2017;19:168 pubmed publisher
    ..CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product., IRCT2015030321315N1 . Registered on 5 April 2015. ..
  29. Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18:917-928 pubmed publisher
    ..CT-P6 showed equivalent efficacy to reference trastuzumab and adverse events were similar. Availability of trastuzumab biosimilars could increase access to this targeted therapy for HER2-positive early-stage cancer. Celltrion Inc. ..
  30. Ramezani A, Mahmoudi Maymand E, Yazdanpanah Samani M, Hosseini A, Toghraie F, Ghaderi A. Improving Pertuzumab production by gene optimization and proper signal peptide selection. Protein Expr Purif. 2017;135:24-32 pubmed publisher
    ..This sequence was used to produce Pertuzumab producing CHO-K1 stably transfected cells. This result is useful for producing Pertuzumab as a biosimilar drug. ..
  31. Egeth M, Soosaar J, Nash P, Choquette D, Infante R, Ramey D, et al. Patient and Healthcare Professionals Preference for Brenzys vs. Enbrel Autoinjector for Rheumatoid Arthritis: A Randomized Crossover Simulated-Use Study. Adv Ther. 2017;34:1157-1172 pubmed publisher
    ..Merck & Co., Inc. ..
  32. Hanes V, Chow V, Zhang N, Markus R. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects. Cancer Chemother Pharmacol. 2017;79:881-888 pubmed publisher
    ..No differences in safety and tolerability between treatments were noted; no subject tested positive for binding anti-bodies. ..
  33. Scheinberg M, Castaneda Hernandez G. Anti-tumor necrosis factor patent expiration and the risks of biocopies in clinical practice. Arthritis Res Ther. 2014;16:501 pubmed publisher
    ..This article comments on various aspects surrounding the use of such biocopies in clinical rheumatology. ..
  34. Walsh G. Biopharmaceutical benchmarks 2014. Nat Biotechnol. 2014;32:992-1000 pubmed publisher
  35. Farfan Portet M, Gerkens S, Lepage Nefkens I, Vinck I, Hulstaert F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?. Eur J Health Econ. 2014;15:223-8 pubmed publisher