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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 29 AusBioFEATURE --- AusBiotech 2009 In addition to the availability of local experience developing biosimilars, the following factors make the Asia Pacific region a favorable destination for their clinical development. Regulatory: Malaysia, Taiwan, India and Japan have issued draft guidelines for abbreviated licensing pathways for biosimilars. Japanese authorities have begun to accept clinical trial data from Taiwan and Korea for local registration. Australia has accepted the European pathway. Patient population: Asia Pacific is home to a large and diverse population with diseases of both the developed world and the developing world. Patients are relatively drug-naïve and have demonstrated good compliance in clinical trials. Development of biosimilars could benefit this population by providing biologics that are available and affordable. Clinical trial timelines: The time taken from submission of application to first patient in could vary between eight and 12 weeks in most Asia Pacific countries, which is comparable to most Western countries. Clinical trial data: A recent report on globalisation of clinical trials, released by the Association of Contract Research Organizations, states that the quality of clinical research data from trials conducted in emerging economies like India and China is comparable with that obtained in US. The clinical trial infrastructure in developed economies like Australia, Singapore, Taiwan and South Korea are considered to be on par with that in Western countries. Cost: the cost of conducting a clinical trial in Asia is significantly lower than most Western countries. Product Approved biosimilars EU US China India Korea hGH Recombinant Insulin --- --- EPO --- IF --- --- IL-2 --- --- --- --- G-CSF --- GM-CSF --- --- Mabs --- --- --- Vaccines --- --- --- Country Population in 1000s (2006) Hospital beds per 10,000  Physicians per 10,000  Trials listed  Biosimilars regulations released in year  Australia 20,530 40 25 1,986 15 Jun 2006 China 1,328,474 22 14 961 --- India 1,151,751 7 6 834 11 Jul 2008 South Korea 48,050 86 16 982 --- Malaysia 26,114 19 7 228 30 Jul 2008 Taiwan 22,894 64 15 1,223 21 Nov 2008 Singapore 4,382 32 15 478 01 Aug 2009 Table -1: Biosimilars approved in major markets Table -2: Snapshot of demographic profle of countries in Asia Pacifc The Asian Pacific region has successfully developed and approved biosimilars with a well established regulatory pathway and clinical trial infrastructure. With the benefit of experience, a favorable regulatory environment, patient access, comparable quality and lower costs, the Asia Pacific region provides definitive advantages for the clinical development of biosimilars. Ingrid Schwarzenberger. 7 1 th EGA Annual Symposium on biosimilars. London April 2009. Committee on Medicinal Products for Human Use. Guideline for similar biological medicinal products. Accessed from: 2 www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf on 5 Aug 2009. Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 2008 Sep; 26(9); 985-90 3 EMEA Workshop on Monoclonal Antibodies. 4 www.emea.europa.eu/meetings/ conferences/2jul09.htm Statistics gleaned from 5 www.who.int/whosis on 03 Aug 2009 for all countries except Taiwan. For Taiwan: www.gov.tw/WHO/index on 18 Dec 2007. Global studies listed in 6 www.clinicaltrials.gov on Dec 2008. www.tga.gov.au/docs/html/euguide/euad_nonc.htm. 7 (Australia adopted EMEA guidelines). Biosimilars regulatory guidelines are expected to be released in 2009 for South Korea.