Global Status of Biosimilars and Its Influential Factors



Abstract Views
1073

Downloads
941

Citations

Share

##plugins.themes.bootstrap3.article.sidebar##

Submitted Oct 3, 2020
Published Nov 8, 2020
10.24018/ejbmr.2020.5.6.565

Abstract viewed = 1073 times

Table of Contents

##plugins.themes.bootstrap3.article.main##

The history of biosimilars started at European Union (EU) in 2006 with one product; however, currently it has been recognized everywhere in the world and EU have highest 64 biosimilar products. United States Food & Drug Administration (USFDA) was little unadventurous with biosimilars; nevertheless, they approved the first biosimilar 09 years after EU approval and presently they have 28 biosimilars which are playing significant role in price cutting of branded biologics. They also have so many biosimilars in product pipeline. Economically emerging countries especially China & India are very aggressive with biosimilars. In view of easy regulation, cheap labor & other cost related factors they are in little advantageous than the rivalries. Under Pharmaceutical Benefits Scheme Australian government is encouraging biosimilars and they already approved 20 biosimilars. Japan, Korea, Canada, South Africa are also promoting biosimilars. However, it is worth mentioning that in spite of enormous potentiality and rapid growth till to date biosimilar market is insignificant compared to total pharmaceutical market and success of biosimilars will depend on the acceptance by the physicians, treatment cost reduction, trust on manufacturer, proper information, drug substitution, efficacy, safety etc.

Keywords: Biosimilars, follow on biologics, branded biologic, USFDA, price-cut, regulation, rapid growth, acceptance, potential, substitution, treatment cost, drug substitution, efficacy and safety

Downloads

Download data is not yet available.

References

  1. Delottie (2015). Global life sciences outlook: Adapting in an era of transformation. Deloitte. Touche Tohmatsu Limited, UK. (Available from https://www2.deloitte.com /content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-life-sciences-report.pdf).
     Google Scholar
  2. Md. Moklesur Rahman Sarker (2014). Recent Trend and Future Prospective of Biotechnology in Pharmaceuticals-Bangladesh Perspective” The Pharma World, Dhaka, Bangladesh, March.
     Google Scholar
  3. Erwin A. Blackstone and Joseph P. Fuhr, Jr. (2012). Innovation and Competition: Will Biosimilars Succeed? Biotechnology Healthcare, USA. Spring; 9(1): 24–27 (Available from https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3351893/).
     Google Scholar
  4. The World Bank Databank (2015). (Available from http://data.worldbank.org/).
     Google Scholar
  5. Ralf Otto, Alberto Santagostino and Ulf Schrader (2014). Rapid growth in biopharma: Challenges and opportunities, McKinsey & Company, USA. December. (Available from http://www.mckinsey.com/ industries/pharmaceuticals-and-medical-products/our-insights/rapid-growth-in-biopharma.
     Google Scholar
  6. SMi (2016). SMi Group’s 7th Annual Biosimilars Europe Conference, London, UK. 29th September to 30th September (Available from https://www.smi- online.co.uk/pharmaceuticals/uk/biosimilars-europe).
     Google Scholar
  7. GaBi (2014). EU guidelines for Generics and Biosimilars Initiative (GaBi), Belgium. biosimilars (www.gabionline.net). Mol, Belgium: Pro Pharma Communications International. July. Available from: www. gabionline.net/Guidelines/EU-guidelines-for-biosimilars.
     Google Scholar
  8. Quintiles IMS (2016). Intercontinental Marketing Services, Health, USA. Available from http://www.quintiles.com/microsites/biosimilars-knowledge-connect/biosimilars-by-region/europe.
     Google Scholar
  9. Tina Valbh, BS Pharm, RPh (2016). The Value Potential of Biosimilars in the United States, Axium Healthcare Pharmacy. New Jersey, USA. February (Available from http://www.Specialty pharmacytimes.com/publications/specialty-pharmacy-times/2016/february-2016/the-value-potential-of-biosimilars-in-the-united-states/P-2).
     Google Scholar
  10. GaBi (2020). Generics & Biosimilars Initiative. Biosimilars approved in Europe. Available from http://www.gabionline.net/ Biosimilars/General/Biosimilars-approved-in-Europe#:~:text= Two%20 biosimilar% 20applications %20 were%20refused%20by%20the%20agency%2C,of%2058%20biosimilars%20approved%20for%20use%20in%20Europe.
     Google Scholar
  11. Jun Wang and Shein-Chung Chow (2012). On the Regulatory Approval Pathway of Biosimilar Products, Pharmaceuticals (Basel), USA. Aprli; 5(4): 353–368. (Available from https://www.ncbi.nlm.nih .gov/pmc/articles/PMC3763644/.
     Google Scholar
  12. ppd Report (2016). World biosimilars market to hit $26.3M by 2020. Pharmaceutical Product Development (ppd). USA. May, 26.
     Google Scholar
  13. Karsten Dalgaard, Matthias Evers Jorge Santos De Silva (2013). Biosimilars Seven years on: where are we and what’s next. McKinsey & Company, USA. February.
     Google Scholar
  14. The Pharma Letter (2016). FDA approves Inflectra, the first biosimilar MAb in the USA. Putney, London, UK. 04 June (Available from http://www.thepharmaletter.com/article/fda-approves-inflectra-the-first-biosimilar-mab-in-the-usa).
     Google Scholar
  15. Judith Stewart (2020). How many biosimilars have been approved in the United States? Drugs.com. Available from www.drugs.com /medical-answers/many-biosimilars-approved-united-states-3463281/.
     Google Scholar
  16. Andrew W. Mulcahy, Zachary Predmore, and Soeren Mattke (2014). The Cost Savings Potential of Biosimilar Drugs in the United States. Rand Corporation, US. November.
     Google Scholar
  17. Rodeina Chlland (2011). Biosimilars in Emerging Markets Is It A Level Playing Field? PRA Health Sciences, Green Park, UK.
     Google Scholar
  18. McKinsey & Company (2019). What’s next for biosimilars in emerging markets? https://www.mckinsey.com/industries/ pharmaceuticals -and-medical-products/our-insights/whats-next-for-biosimilars-in-emerging-markets.
     Google Scholar
  19. Monica Malik, Sergei Tjulandin and Gilberto de Lima Lopes, Jr. (2016). Biosimilars in Low-and Middle-Income Markets: A Case Study of India and Russia. American Society of Clinical Oncology (ASCO) Annual Meeting, USA. 26 May. Available from https://am.asco.org/biosimilars -low-and-middle-income-markets-case-study-india-and-russia.
     Google Scholar
  20. Hye-NaKang, RobinThorpe, IvanaKnezevic (2020). The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biologicals. Volume 65, May 2020, Pages 1-9.
     Google Scholar
  21. Phillip Miller (2012). China: Tipping the Balance: Risks and Opportunities in Biosimilars. Deallus Consulting Ltd., UK (Available from http://www.Deallusconsulting .com/china-tipping-balance-risks-opportunities-biosimilars).
     Google Scholar
  22. Zeck Huang (2020). Regulatory Update: Biosimilars in China. Paraxel. USA.
     Google Scholar
  23. Big Molecule Watch (2016). South Korea’s Biosimilars Industry Poised to Grow Domestically and Abroad. Big Molecule Watch, GoodwinProcter LLP, US. 16 June. (Available from http://www.bigmoleculewatch.com/2016 /06/16/south-koreas-biosimilars-industry-poised-to-grow/).
     Google Scholar
  24. Simon Mundy and Andrew Ward (2015). South Korea pushes to be new force in Pharmaceuticals. The Financial Times, London, UK. 10 June. Available from https://www.ft.com/ content/0d1367ac-09a9-11e5-8534-00144feabdc0.
     Google Scholar
  25. GaBi (2018). Biosimilars approved in South Korea. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea#:~:text=To%20date%2C%20the %20MFDS%20has% 20approved%2011%20biosimilars, for%20use%20in%20South%20 Korea%2C%20see%20Table%201.
     Google Scholar
  26. The Economic Times (2016). Cipla to invest Rs 590 crore for a biosimilars plant in South Africa. The Economic Times, India. 08 July. (Available from: http://economictimes.indiatimes.com/industry /healthcare/biotech/pharmaceuticals/cipla-to-invest-rs-590-crore-for-a-biosimilars-plant-in-south-africa/articleshow /53113643.cms).
     Google Scholar
  27. GaBi (2017). South Africa approves first non-originator biological. http://www.gabionline.net/Biosimilars/News/South-Africa-approves-first-non-originator-biological.
     Google Scholar
  28. Tomas Gabriel Bas and Carolina Oliu Castillo (2015). BioMed Research International. USA. Volume 2016, Article ID 5910403, 12 pages. Available from http://dx.doi.org/10.1155/2016/5910403 Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia-Overview, Evolution, and Regulations Assessment.
     Google Scholar
  29. GaBi (2019). Biosimilars approved in Japan. www.gabionline.net/ Biosimilars/General/Biosimilars-approved-in-Japan.
     Google Scholar
  30. TGA (2016): Biosimilars in Pharmaceutical Price Benefit Scheme. Therapeutic Goods Australia (TGA). (Available from http://www.pbs.gov.au /info/general/ biosimilars).
     Google Scholar
  31. Jane Owen and Rebecca Currey (2016). Australian Government embarks on push for growth of Biosimilars, Bird & Bird, London, UK. March. Available from http://www.twobirds.com/en/news/ articles/2016/australia/australian-government-embarks-on-push-for-growth-of-biosimilars.
     Google Scholar
  32. GaBi (2019). Biosimilars approved in Australia. http://www.gabionline.net/index.php/Biosimilars/General/Biosimilars-approved-in-Australia.
     Google Scholar
  33. J Bradley White, Nathaniel Lipkus, Osler, Hoskin and Harcourt (2012). Biosimilars in Canada: at a tipping point, Intellectual Asset Management (IAM), London, UK. (Available from http://www.iam-media.com/ Intelligence/IAM-Life-Sciences/2016/Articles/Biosimilars-in-Canada-at-a-tipping-point)
     Google Scholar
  34. Smart & Bigger (2020). Update on biosimilars in Canada-August 2020 https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-august-2020.
     Google Scholar
  35. Md. Abu Zafor Sadek (2016). Growth Potential of Biosimilar Products in Bangladesh. 5th European Biosimilars Congress, Valencia Spain. 27-29 June. Available from http://biosimilars-biologics.pharmaceuticalconferences. com/europe/ppt/2016/growth-potential-of-biosimilar-products-in-bangladesh.
     Google Scholar
  36. Jack Cush (2016). Biosimilar Reports. Rheumnow, Texsas, USA. 06 October. Available from http://rheumnow.com/content/biosimilar-reports-%E2%80%93-october-2016).
     Google Scholar
  37. Gary H Lyman (2019): New Biosimilar Approvals for Myeloid Growth Factors and Anemia. Official Journal of the National Comprehensive Cancer Network. Available from https://jnccn.org/ view/journals/jnccn/17/5.5/article-p622.xml.
     Google Scholar
  38. McGowan & Rick Lozano (2019): Biosimilars: Market Insights & Growth Factors. AmerisourceBergan Corporation. Available from www.amerisourcebergen.com/ insights/manufacturers/biosimilars-market-insights-and-growth-factors.
     Google Scholar
  39. Nitin Naikn and Sanjeev Kumar (2016). 6 Factors Driving Global Biosimilar Market Growth. Life Science Connect, Philadelphia, USA. 28 April. Available from http://www.biosimilardevelopment. com/doc/factors-driving-global-biosimilar-market-growth-0001.
     Google Scholar
  40. Fortune Business Insight (2020). The global Oncology Biosimilars Market . Pune, India, Oct. 14, 2020.
     Google Scholar