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Biyobenzer ilaçların preklinik ve klinik performanslarının değerlendirilmesi

Yıl 2021, Cilt: 60 Özel Sayı:1 (Romatoloji), 83 - 87, 20.01.2021

Turgut Emrah Bozkurt

https://doi.org/10.19161/etd.863718
Cited By: 1

Öz

Biyoteknolojik ilaçlar doku veya hücre kültürleri gibi canlı organizmalar aracılığıyla genellikle rekombinant DNA teknolojisi kullanılarak üretilen kompleks, büyük moleküllerdir. Biyobenzerler daha önce onaylanmış olan referans biyolojik ilaçlara yüksek oranda benzeyen biyolojik ilaçlardır. Biyobenzer ilaçların referans ilaca kalite, etkililik ve güvenlilik açısından benzerliğinin gösterilmesi küçük moleküllerle karşılaştırıldıklarında çok daha karmaşık bir süreçtir. Ulusal ve uluslararası kılavuzlar biyobenzerlerin performanslarının değerlendirilebilmesi için genel bir çerçeve oluşturmuşlardır. Ancak, biyoteknolojik ilaçların sayılarının fazlalığı ve etki mekanizmalarının çeşitliliği bu ürünlerin performanslarının değerlendirilmelerini karmaşık bir hale getirmektedir. Bu makalede biyobenzerlerin eşdeğerliğini değerlendirmek için önemli noktalar son gelişmeler ve ilgili kılavuzlar doğrultusunda sunulmuş ve tartışılmıştır.

Anahtar Kelimeler

Biyobenzer, ilaç, preklinik, klinik.

Kaynakça

  • EMEA/CHMP/BMWP/42832/2005 Rev.1. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 18 December 2014.
  • Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. Guidance for Industry. https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. May 2019, Biosimilars.
  • https://www.genengnews.com/a-lists/top-15-best-selling-drugs-of-2018/
  • https://www.statista.com/statistics/299138/top-selling-biotech-drugs-based-on-revenue/
  • EMEA/CHMP/BMWP/118264/2007 Rev.1. Committee for Medicinal products for Human (CHMP) Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins. 10 November 2016.
  • EMEA/CHMP/BMWP/32775/2005_Rev.1. Committee for Medicinal products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. 26 February 2015.
  • EMEA/CHMP/BMWP/301636/2008 Rev.1. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. 28 June 2018.
  • EMEA/CHMP/BMWP/31329/2005. Guidance on Similar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor. London, 22 February 2006.
  • EMA/CHMP/BMWP/652000/2010. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing interferon beta. 21 February 2013.
  • EMEA/CHMP/BMWP/94528/2005 Rev.1. Committee for Medicinal Products for Human Use (CHMP) Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guideline on similar medicinal products containing somatropin. 28 June 2018.
  • EMA/CHMP/BMWP/403543/2010. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. 30 May 2012.
  • Park W, Hrycaj P, Jeka S et al. A randomised, doubleblind, 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.
  • 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.
  • Takeuchi T, Yamanaka H, Tanaka Y et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2015; 25: 817-24.
  • Yoo DH, Racewicz A, Brzezicki J et al. A Phase III randomized study to evaluate the efficacy and safety of CTP13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016;18:82.
  • Lee YJ, Shin D, Kim Y et al. A randomised Phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects. Br J Pharmacol 2016; 82: 64-73.
  • Emery P, Vencovsky´ J, Sylwestrzak A et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017; 76: 51-7.

Evaluation of preclinical and clinical performance of biosimilar drugs

Yıl 2021, Cilt: 60 Özel Sayı:1 (Romatoloji), 83 - 87, 20.01.2021

Turgut Emrah Bozkurt

https://doi.org/10.19161/etd.863718
Cited By: 1

Öz

Biotechnological drugs are complex, large molecules which are manufactured by living organisms such as tissue cultures or cells mostly using recombinant DNA technology. Biosimilars are biological medicines that are highly similar to their already approved biological reference medicines. To establish the similarity of a biosimilar to its reference drug in means of quality, efficacy and safety is a much more complicated procedure when compared to small molecules. International and national guidelines have created a general perspective for evaluating the performance of biosimilars. However, the large variety of biotechnological drugs and their wide range of action mechanisms make this evaluation process complicated. In this paper, the major issues for evaluating the similarity of biosimilars are reported and discussed according to the recent literature and guidelines.

Anahtar Kelimeler

Biosimilar, drug, preclinical, clinical.

Kaynakça

  • EMEA/CHMP/BMWP/42832/2005 Rev.1. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 18 December 2014.
  • Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. Guidance for Industry. https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. May 2019, Biosimilars.
  • https://www.genengnews.com/a-lists/top-15-best-selling-drugs-of-2018/
  • https://www.statista.com/statistics/299138/top-selling-biotech-drugs-based-on-revenue/
  • EMEA/CHMP/BMWP/118264/2007 Rev.1. Committee for Medicinal products for Human (CHMP) Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins. 10 November 2016.
  • EMEA/CHMP/BMWP/32775/2005_Rev.1. Committee for Medicinal products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. 26 February 2015.
  • EMEA/CHMP/BMWP/301636/2008 Rev.1. Committee for Medicinal Products for Human Use (CHMP). Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. 28 June 2018.
  • EMEA/CHMP/BMWP/31329/2005. Guidance on Similar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor. London, 22 February 2006.
  • EMA/CHMP/BMWP/652000/2010. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing interferon beta. 21 February 2013.
  • EMEA/CHMP/BMWP/94528/2005 Rev.1. Committee for Medicinal Products for Human Use (CHMP) Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guideline on similar medicinal products containing somatropin. 28 June 2018.
  • EMA/CHMP/BMWP/403543/2010. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. 30 May 2012.
  • Park W, Hrycaj P, Jeka S et al. A randomised, doubleblind, 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.
  • 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.
  • Takeuchi T, Yamanaka H, Tanaka Y et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2015; 25: 817-24.
  • Yoo DH, Racewicz A, Brzezicki J et al. A Phase III randomized study to evaluate the efficacy and safety of CTP13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016;18:82.
  • Lee YJ, Shin D, Kim Y et al. A randomised Phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects. Br J Pharmacol 2016; 82: 64-73.
  • Emery P, Vencovsky´ J, Sylwestrzak A et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017; 76: 51-7.
Toplam 17 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Sağlık Kurumları Yönetimi
Bölüm Olgu Sunumu
Yazarlar

Turgut Emrah Bozkurt 0000-0001-8650-176X

Yayımlanma Tarihi 20 Ocak 2021
Gönderilme Tarihi 6 Nisan 2020
Yayımlandığı Sayı Yıl 2021 Cilt: 60 Özel Sayı:1 (Romatoloji)

Kaynak Göster

Vancouver Bozkurt TE. Biyobenzer ilaçların preklinik ve klinik performanslarının değerlendirilmesi. ETD. 2021:83-7.

Cited By

Muğla Sıtkı Koçman Üniversitesi Tıp Fakültesi İç Hastalıkları Anabilim Dalı Romatoloji ve Onkoloji Bilim Dallarında Reçete Edilen İlaçlar İçindeki Biyoteknolojik Ürünlerin Retrospektif Olarak İncelenmesi
Muğla Sıtkı Koçman Üniversitesi Tıp Dergisi
https://doi.org/10.47572/muskutd.1096902
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