Biosimilars

How far have we come? What will be on the market as alternative to existing products?


There is a biosimilar to infliximab, CT-P13 by South Korean based Celltrion, which is expected to be launched in the first half of 2013.


W. Park and colleagues demonstrated equivalence in pharmacokinetics, safety, and efficacy of ct-p13 and infliximab in patients with ankylosing spondylitis in a phase 1 randomized, double-blind study. 150 patients with active ankylosing spondylitis were equally randomized and received “either CT-P13 or infliximab (5 mg/kg, 2-hour IV infusion per dose) at weeks 0, 2, and 6 (dose-loading phase) and at weeks 14, 22, and 30 (maintenance phase).” Concerning adverse events: “AEs due to infusion reactions considered related to study drug were reported in 5 patients in the CT-P13 arm, and 6 patients in the infliximab arm. Tuberculosis was reported in 2 patients in the CT-P13 arm and in 1 patient in the infliximab arm.”


BTW: „Dr. Jürgen Braun, Mainz-Gonsenheim, Germany“ isn´t identical to „Dr. Jürgen Braun, Rheumazentrum Ruhrgebiet, Herne, Germany“.


[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
W. Park1, P. Hrycaj2, V. Kovalenko3, P. Miranda4, S. Gutierrez-Ureña5, Y. Lee6, M. Lim1, C. Ahn7, H. Kim8, D. Yoo9, J. Braun10. 1Inha University Hospital, Incheon, Republic of Korea; 2Prywatna Praktyka Lekarska Reumatologiczno-Immunologiczna, Poznan, Poland; 3National Scientific Center, Kiev, Ukraine; 4Centro de Estudios Reumatológicos, Santiago, Chile; 5Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico; 6Kyung Hee University Hospital, Seoul, Republic of Korea; 7UT Southwestern Medical Center, Dallas, United States; 8Celltrion, Incheon; 9Hanyang University Medical Center, Seoul, Republic of Korea; 10Praxis Dr. Jürgen Braun, Mainz-Gonsenheim, Germany
Conclusions: CT-P13 and infliximab are equivalent in terms of AUCτ and Cmax,ss in patients with AS. In addition, CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of infliximab up to week 30.


D. Yoo and collaegues presented a randomized, double-blind, phase 3 study, which demonstrates clinical equivalence of ct-p13 to infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis.


[FRI0143] A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY DEMONSTRATES CLINICAL EQUIVALENCE OF CT-P13 TO INFLIXIMAB WHEN CO-ADMINISTERED WITH METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - POSTER TOURS
D. Yoo1, P. Miranda2, M. Piotrowski3, E. Ramiterre4, V. Kovalenko5, N. Prodanovic6, M. Tee7, S. Gutierrez-Ureña8, R. Jimenez9, O. Zamani10, S. Lee11, H. Kim12, W. Park13, U. Müller-Ladner14. 1Hanyang University Medical Center, Seoul, Republic of Korea; 2Centro de Estudios Reumatologicos, Santiago, Chile; 3Reumed, Lubin, Poland; 4Brokenshire Memorial Hospital, Davao City, Philippines; 5National Scientific Center, Kiev, Ukraine; 6Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina; 7Medical Center Manila, Manila, Philippines; 8Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico; 9Centro de Estudios Investigaciones Clinicas, Viña del Mar, Chile; 10Rheuma Zentrum Favoriten, Vienna, Austria; 11University of New Mexico, Albuquerque, United States; 12Celltrion; 13Inha University Hospital, Incheon, Republic of Korea; 14Kerchoff-Klinik GmbH, Bad Nauheim, Germany
Conclusions: CT-P13 and infliximab are equivalent in terms of ACR20 in patients with RA. In addition, CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of infliximab up to week 30.


There might be a biosimilar to rituximab to be produced in Europe. But what of the biosimilar already on the market in India?


A. da Silva and colleagues presented an abstract to “demonstrate a scientifically-based approach for the characterisation and development of a high-quality biosimilar monoclonal antibody.” Are Sandoz Biopharmaceuticals, Hexal AG, and Novartis Pharma AG wolking on a rituximab biosimilar?


[AB1403] COMPREHENSIVE TARGET-DIRECTED APPROACH FOR THE DEVELOPMENT OF A HIGHLY-COMPARABLE RITUXIMAB BIOSIMILAR
A. da Silva1, R. Grau2, T. Stangler1, H. Summer1, I. Meyer1, A. Rohde1, A. Papandrikopoulou1, J.M. Visser1. 1Sandoz Biopharmaceuticals, Hexal Ag, Holzkirchen, Germany; 2Novartis Pharma AG, Basel, Switzerland
Conclusions: In biosimilars development a much greater emphasis is placed on the early technical development of the product as compared with novel biologic therapeutic development. As such, the development of a biosimilar is in the innovative forefront of establishing and defining "Quality by Design" principles as a target-directed approach. In-depth experience and continuous advancement of this approach ensures a biosimilar product that is highly comparable to the originator product and clinically as safe and efficacious.
EMEA/CHMP/BMWP/42832/2005 and EMA/CHMP/BMWP/403543/2010


I am wondering, why no one at Dr. Reddy´s Lab in India sees the opportunity to market Reditux in other countries or why other pharmaceutical companies fail to market the product worldwide. Reditux is a biosimilar of rituximab, already in use in India, where the cost is only half of rituximab (information thanks to Dr. Shashank Akerkar, Twitter: @doctorakerkar).