Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest ...
Transcript of Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest ...
![Page 1: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/1.jpg)
Hale & Tempest
Generic Country Markets & Biosimilars
Chesapeake
Dr. Brian W Tempest
www.briantempest.com
UK
March 2014
![Page 2: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/2.jpg)
Hale & Tempest
7. Generic Country Markets
![Page 3: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/3.jpg)
Hale & Tempest
Europesource: EGA
![Page 4: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/4.jpg)
Hale & Tempest
Reference Pricing Globally Endemic
Source : Istanbul September 2012
Pharma purchases reduced from 1.7% of GDP to 1.0% of GDP in Turkey
Russia, South Korea & Saudi Arabia health ministries requested Turkish prices
Everybody is referencing everybody else on Pharma prices in Europe
Bulgaria is referencing prices in 17 other countries
![Page 5: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/5.jpg)
Hale & Tempest
Europe – generics take half the volume but a fraction of value sales
![Page 6: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/6.jpg)
Hale & Tempest
EU Chemical Sales
source: Chemistry World September 2013
![Page 7: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/7.jpg)
Hale & Tempest
Open letter to Barroso from the Chairman of INEOS on 7 March 2014
![Page 8: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/8.jpg)
Hale & Tempest
Generic Global Volume Share Source: Sandoz
![Page 9: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/9.jpg)
Hale & Tempest
30 generic packs, >2 years treatment £69200 king size cigarettes £68Source: Generics Bulletin 15 Feb 2013
![Page 10: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/10.jpg)
Hale & Tempest
European Generic Prices Source Ranbaxy
![Page 11: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/11.jpg)
Hale & Tempest
Indian Pharma penetration of the UKsource: FT January 13 2014
![Page 12: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/12.jpg)
Hale & Tempest
Security of Power Supplies in Europesource: Economist 15 April 2014
![Page 13: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/13.jpg)
Hale & Tempest
France Generic Market Source: Generics Bulletin 15 February 2013
![Page 14: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/14.jpg)
Hale & Tempest
US DMFs from Indiasource: Citi Research 2013
![Page 15: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/15.jpg)
Hale & Tempest
Number of USA Para IVs source: Generics Bulletin 14 September 2012, quarter indian
![Page 16: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/16.jpg)
Hale & Tempest
USA Generic Market - Latest Challengessource: Jefferies 10 March 2014
![Page 17: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/17.jpg)
Hale & Tempest
Africa Management source Ranbaxy
![Page 18: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/18.jpg)
Hale & Tempest
Nigeria, South Africa & Angolasource: Economist 12 April 2014
![Page 19: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/19.jpg)
Hale & Tempest
African Factories
![Page 20: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/20.jpg)
Hale & Tempest
Japan Generic Market
source: Citi Research August 2013
![Page 21: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/21.jpg)
Hale & Tempest
Japan Generic Opportunity
![Page 22: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/22.jpg)
Hale & Tempest
Japanese Generic Marketsource: Mint 28 January 2014
![Page 23: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/23.jpg)
Hale & Tempest
Brazil Generic Packs
![Page 24: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/24.jpg)
Hale & Tempest
Brazil Top 10 Generic Cos
![Page 25: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/25.jpg)
Hale & Tempest
Russia 2020 Strategy for Public Health
![Page 26: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/26.jpg)
Hale & Tempest
Russian Market Evolutionsource: Frost & Sullivan 2011
![Page 27: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/27.jpg)
Hale & Tempest
Vaccine Plant to take 1/3 Russian Market source: St Petersburg Times, 16 April 2014
![Page 28: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/28.jpg)
Hale & Tempest
USA Generic Market - Latest Challengessource: Jefferies 10 March 2014
![Page 29: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/29.jpg)
Hale & Tempest
Russia VLS List
![Page 30: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/30.jpg)
Hale & Tempest
Russia 2020 Strategy 90% local manufacture of VLS list
![Page 31: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/31.jpg)
Hale & Tempest
Russia 2020 Strategy 50% local manufacture of all products
![Page 32: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/32.jpg)
Hale & Tempest
New Novartis Plant in St Petersburgsource: Top Emerging Pharmaceutical Markets by Kathlyn Stone
![Page 33: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/33.jpg)
Hale & Tempest
Russia & India – Big Picturesource: ET March 26 2014
![Page 34: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/34.jpg)
Hale & Tempest
Russia & India – Big Picturesource: ET March 26 2014
![Page 35: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/35.jpg)
Hale & Tempest
Indian Pharma in Russia - DRLsource: website, 20 years
![Page 36: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/36.jpg)
Hale & Tempest
Indian Pharma in Russia - Ranbaxysource: RUR, 20 years, 15% MS IMS May 2013, across 56 Regions
![Page 37: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/37.jpg)
Hale & Tempest
Chinese Debt 200% of GDP in 2013source: FT 2 April 2014
![Page 38: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/38.jpg)
Hale & Tempest
Chinese NGOssource: Economist 12 April 2014
![Page 39: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/39.jpg)
Hale & Tempest
China Pharma Industry Capex PlansSource: Stravencom
![Page 40: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/40.jpg)
Hale & Tempest
China Price Cutssource: Jefferies
![Page 41: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/41.jpg)
Hale & Tempest
China API Exports decline by -9%source: Pharmatiimes February 21 2014
![Page 42: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/42.jpg)
Hale & Tempest
Hisun Pfizer Pharmaceuticals Ltdsource: Launch Announcement September 12 2013
![Page 43: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/43.jpg)
Hale & Tempest
Hisun USAsource: website
![Page 44: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/44.jpg)
Hale & Tempest
Hisun USA acquires FDA approved DPIsource: Press Release January 17 2012
![Page 45: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/45.jpg)
Hale & Tempest
Hisun USA acquires FDA approved DPIsource: Press Release January 17 2012
![Page 46: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/46.jpg)
Hale & Tempest
China: Optimistic view of Domestic Marketsource: Jefferies 17 March 2014
![Page 47: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/47.jpg)
Hale & Tempest
China Provincial Tenderssource: Jefferies 17 March 2014
![Page 48: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/48.jpg)
Hale & Tempest
Sino Biopharm strongest domestic pipeline source: Jefferies March 17 2014
![Page 49: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/49.jpg)
Hale & Tempest
Zhejiang Huahai(Novast also received an ANDA for an OC in 2010)
![Page 50: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/50.jpg)
Hale & Tempest
China - Actavis Withdrawssource: Bloomberg January 15 2014
![Page 51: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/51.jpg)
Hale & Tempest
South Africa Generics
![Page 52: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/52.jpg)
Hale & Tempest
Middle East & North Africa
![Page 53: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/53.jpg)
Hale & Tempest
Jordan punches above its Weight
![Page 54: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/54.jpg)
Hale & Tempest
Canada Generic Market Source: Generics Bulletin 15 Feb2013
![Page 55: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/55.jpg)
Hale & Tempest
Myanmar – a new market
![Page 56: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/56.jpg)
Hale & Tempest
8. Biosimilars
![Page 57: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/57.jpg)
Hale & Tempest
Which Way?
![Page 58: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/58.jpg)
Hale & Tempest
Biologics & Small Molecules source: Kozlowski et al., N England J Med, 365:5, 2011
![Page 59: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/59.jpg)
Hale & Tempest
Estimated 2016 sales of Top 20 products Source: Cowen
![Page 60: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/60.jpg)
Hale & Tempest
Biosimilar Share to 2018 source: EvaluatePharma 2012
![Page 61: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/61.jpg)
Hale & Tempest
Monoclonal antibodies $m Source: Synthon
![Page 62: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/62.jpg)
Hale & Tempest
New Biosimilar Company (with Merck)
![Page 63: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/63.jpg)
Hale & Tempest
Korean Pharma in Biosimilars
source: Citi Research August 2013
![Page 64: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/64.jpg)
Hale & Tempest
Biosimilars from China/India Source: New York Times 20 Sep 2011
![Page 65: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/65.jpg)
Hale & Tempest
Biotech Drugs where India has no DMF Source: JGM Volume 6 p333 sep 2009
![Page 66: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/66.jpg)
Hale & Tempest
Biosimilars from IndiaSource: Citi 25 September 2013
•Market opportunity of $1.5b to $2b for US & EU
•More clarity now on regulatory pathways
•OECD -$100m for R&D development of a MAB, $300m-$400m to set up manufacturing capacity of 100,000L with annual R&D at $100m
•Developing Countries - $200m sales potential, $20m R&D per year, manufacturing capacity of 1,000L planned
•India companies will enter emerging markets but use partnerships and alliances for OECD eg DRL
•Developing Countries limited by affordability issues
![Page 67: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/67.jpg)
Hale & Tempest
Biosimilars Key Issue - Interchangeabilitysource: GaBi Journal Biologics & Biosimilars 28 December 2013
![Page 68: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/68.jpg)
Hale & Tempest
Biosimilar Market SizesSource: IMS, FT February 9 2014
•Global Biologics including Big Pharma blockbusters in 2012 is $170 b
•Biosimilars market size in 2012 is $2.5b and in 2020 is estimated at $25b
•VERSUS•cost of manufacturing plant, •cost of clinical trials, •lower hospital tender prices, •no interchangeability, cost of reps, •patient-innovator relationship, •competition from South Korea, •authorised generics
![Page 69: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/69.jpg)
Hale & Tempest
First Herceptin Trastuzumab Biosimilarsource: ET January 14 2014 Rs 40,000 per 440mg vial, Roche halved price at Rs 55,000
![Page 70: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/70.jpg)
Hale & Tempest
Sandoz Biosimilars – an 12 years ROI source: Pharmacloud June 2012
![Page 71: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/71.jpg)
Hale & Tempest
India Pharma in Biosimilars
source: Citi Research August 2013
![Page 72: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/72.jpg)
Hale & Tempest
BiosimiIar Challenges for CEOs Do I enter or keep out?
Rituximab >100 patient CT for Roche, >600 patient CT for Generic companies
Interchangeability (AB rating) unlikely Cabilly patents may delay US mAbs EU mAb in 2013 from Hospira/Celltrion EPO biosimilar side effects in Thailand Many biosimilar manufacturers in China but
few will reach EU/USA Scientifically challenging - Amgen Biobetters need a full dossier with health
economic data
![Page 73: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/73.jpg)
Hale & Tempest
Biosimilar Alliances – to share the risk
Cipla & Biomab, China $165m 12 products Richter & Stada – mABs Celltrion, Korea -Hospira, Egis, Hikma, BB, etc Biocon & Mylan, USA, mABs: Xbiotech Teva & Lonza, EU – dissolved July 2013 Biocon Idec & Samsung, Japan – now Merck Watson & Amgen, USA Fuji Film & Kyowa Hakko Kirin DRL & Merck-Serono, Germany – mABs Bionovis (Brazil) & Merck Serono - 6
![Page 74: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/74.jpg)
Hale & Tempest
NIBS (tyrosine kinase inhibitors)Will these small molecules replace mAbs?
Axitinib, Pfizer, cancer Cediranib, AZ, cancer Pazopanib, GSK, cancer Regorafenib, Bayer, cancer Semaxanib, Sugen, cancer Sorafenib, Bayer(Nexavar),cancer Sunitinib, Pfizer, cancer Toceranib, Pfizer, cancer Vandetanib, AZ, cancer
Tofactinib, Pfizer, RA
![Page 75: Hale & Tempest Generic Country Markets & Biosimilars Chesapeake Dr. Brian W Tempest brian.tempest@clara.co.uk UK March 2014.](https://reader038.fdocuments.us/reader038/viewer/2022110209/56649e025503460f94aed244/html5/thumbnails/75.jpg)
Hale & Tempest
BTD : Breakthrough Therapy Designationsource: Evaluate,FDA Jan 2014 31 products in 2013 6 ibs & 3 mabs J&J 4, GSK 3, Nov 3, smaller cos 12