Biosimilars: A systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases;Biosimilars: Ein systematischer review zu publizierten und laufenden klinischen studien zu antipsoriatika bei chronisch inflammatorischen erkrankungen

JDDG - Journal of the German Society of Dermatology

Volumn 13, Issue 4, 2015, Pages 294-301

  Nast, Alexander ^a   Rosumeck, Stefanie ^a   Seidenschnur, Karin ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ABP 501; ADALIMUMAB; ANTIPSORIASIS AGENT; BIOSIMILAR AGENT; CHS 0214; CT P 13; ETANERCEPT; FOLIC ACID; GP 2015; GP 2017; HD 203; INFLIXIMAB; METHOTREXATE; NI 071; SB 2; SB 4; UNCLASSIFIED DRUG; USTEKINUMAB; BIOLOGICAL PRODUCT; DERMATOLOGICAL AGENT;

ANKYLOSING SPONDYLITIS; CHRONIC INFLAMMATION; CROHN DISEASE; DRUG EFFICACY; DRUG SAFETY; HUMAN; IMMUNOGENICITY; PSORIASIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SHORT SURVEY; SYSTEMATIC REVIEW; ULCERATIVE COLITIS; CHRONIC DISEASE; INFLAMMATION; META ANALYSIS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; CHRONIC DISEASE; DERMATOLOGIC AGENTS; HUMANS; INFLAMMATION; PSORIASIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84925869027     PISSN: 16100379     EISSN: 16100387     Source Type: Journal    
DOI: 10.1111/ddg.12621     Document Type: Short Survey

References (21)

1. European Medicines Agency. European Medicines Agency - Q&A: Similar biological products - Biosimilar medicines. 2014. http://www.ema.europa.eu:80/ema/index.jsp?curl=pages/special-topics/document-listing/document-listing-000318.jsp. Accessed: 2014 Jun 02.
2. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). 2012. http://www.ema.europa.eu/docs/en-GB/document-library/Medicine-QA/2009/12/WC500020062.pdf. Accessed: 2014 Jun 02.
3. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/06/ WC500128686.pdf. Accessed: 2014 Jun 02.
4. Higgins JP, Altman DG, Gotzsche PC et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
5. Yoo DH, Hrycaj P, Miranda P et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72: 1613-20.
6. Yoo DH, Racewicz A, Brzezicki J, et al. OP0068 A Phase 3 Randomised Controlled Trial to Compare CT-P13 with Infliximab in Patients with Active Rheumatoid Arthritis: 54 Week Results from the Planetra Study. Ann Rheum Dis. 2013; 72: A73.
7. Park W, Hrycaj P, Jeka S et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605-12.
8. Park W, Hrycaj P, Kovalenko V et al. OP0167 A randomized, double-blind, phase 1 study demonstrates equivalence in pharmacokinetics, safety, and efficacy of CT-P13 and infliximab in patients with ankylosing spondylitis. Ann Rheum Dis 2013; 71: 111.
9. Park W, Jaworski J, Brzezicki J et al. FRI0421 A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of ct-p13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the planetas study. Ann Rheum Dis 2013; 72: A516-A17.
10. Amgen. Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (Humira®) in Adults With Moderate to Severe Plaque Psoriasis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01970488. NLM Identifier: NCT01970488.
11. Sandoz. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (ADACCESS). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT02016105. NLM Identifier: NCT02016105.
12. Amgen. Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (RA). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01970475. NLM Identifier: NCT01970475.
13. Sandoz. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel (EGALITY). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01891864. NLM Identifier: NCT01891864.
14. Samsung Bioepis Co. Ltd. A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01895309. NLM Identifier: NCT01895309.
15. Hanwha Chemical. Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01270997. NLM Identifier: NCT01270997.
16. Coherus Biosciences Inc. Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT02115750. NLM Identifier: NCT02115750.
17. Samsung Bioepis Co. Ltd. A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01936181. NLM Identifier: NCT01936181.
18. Nichi-Iko Pharmaceutical Co. Ltd. A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 May 26]. Available from http://ClinicalTrials.gov/show/NCT01927263. NLM Identifier: NCT01927263.
19. Schiestl M, Stangler T, Torella C et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29: 310-2.
20. Zylka-Menhorn V, Korzilius H. Biosimilars: Das Wettrennen ist in vollem Gange. Dtsch Arztebl International 2014; 111: 452-5.
21. Radtke MA, Augustin M. Biosimilars in psoriasis: what can we expect? J Dtsch Dermatol Ges 2014; 12: 306-12.