1. Biosimilars in Developing Countries: Key Issues
Dr. Brian W Tempest
Ad Hoc Expert Group Meeting
UNCTAD, Geneva, Switzerland
21 January 2015

2. Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade.
Brian is the Editor of the prestigious Journal of Generic Medicines. Previously he worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until He was then Chief Mentor and Non Executive Director until 2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director Far East and Regional Director Middle East & Africa from 1985 to 1992.
Brian has worked in the Pharmaceutical Industry for the last 44 years and has managed Healthcare businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan and India. He has also led many sessions at Investor Meetings held around the world from Tokyo to Las Vegas.
He is now a Non Executive Director of Religare Capital Markets, Fortis Healthcare , SRL Diagnostics and Glenmark Pharmaceuticals. He is a member of the SCRIP Global awards panel. Brian speaks at global conferences and more information on these presentations can be found on his website He is also an international advisor to UNCTAD and MAPE
Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became Chairman of the Advisory Board for the Lancaster University Management School, UK. He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is also Executive Chairman of Hale & Tempest Co Ltd

3. Biosimilars Which Way?

4. Sanofi R&D - 72% Biologics & 50% mAbs source: Pharma Times 15 January 2015

5. Biosimilar Share to 2018 source: EvaluatePharma 2012

6. Biologics in 2016 Source: Cowen

7. Medicines getting More Expensive - USA source: Evaluate 2014

8. USA Most Expensive Medicines source: Evaluate 2014

9. Top 5 Approved Drugs in H1 - 40% mAbs source: Evaluate 2014

10. USA BTD 2013 source: Evaluate 2014, 7 nibs, 3 mAbs out of 33

11. Top 10 Biologics in 2013 $68b source: Evaluate 2014

12. Big Pharma Profit Margins from Biologics source: Fiscal Year 2011 Roche 2014

13. India Disease Profile source: Planning Commission India, Gyan Research 2014

14. Monoclonal Antibodies Complexity source: Roche 2014

15. Three Waves of Biosimilars source: SG EGA conference 2013

16. Biosimilars EU Patents Source:

17. EU SPCs ending each month for mAbs source: Generics Bulletin 8 August 2014

18. 12 year data exclusivity in USA source: An Outlook on US Biosimilar Competition, 2014

19. Patents on Global Biologic Sales source: Biosimilars: A guide to Regulatory & IP Issues Jan 2015

20. Biosimilar Challenges for USA Approval source: Roche 2014

21. Biosimilar Regulatory Pathways source: Roche 2014

22. Volume Effect from Biosimilars source: IMS December 2011

23. Biosimilar Uptake in Europe source: Roche 2014

24. Biosimilars & Big Pharma source: Pfizer presentation January 2015

25. Biosimilar Global Sales vs Forecast source: Roche 2014

26. Global Biosimilars source: Edelweiss 2014

27. Biosimilar Leading Companies source: Novartis 2014

28. 700 Biosimilars under Development source: PharmaTimes 30 September 2014

29. Sandoz Business Model source: Pharmacloud June 2012

30. Celltrion Manufacturing Facility source: Celltrion website, 140,000L expanding to 230,000L capacity

31. India R&D Expenses as % Sales source: Edelweiss 2014

32. India Biologics source: Edelweiss 2014

33. Biosimilars 1% of DRL Sales source: Edelweiss Research 2014

34. DRL Biosimilar Regulatory Challenges source: Roche 2014

35. First Herceptin Trastuzumab Biosimilar source: ET January Rs 40,000 per 440mg vial, Roche halved price at Rs 55,000

36. Licensed in from USA source: Biopharma Reporter 3 Dec 2014

37. Biosimilar Alliances – to share the risk
Serum Institute & NeuClone
Richter & Stada – mAbs
Celltrion, Korea -Hospira, Egis, Hikma, BB, etc
Biocon & Mylan, USA, mAbs
Teva & Lonza, EU – dissolved July 2013
Biocon Idec+Samsung, Japan - now Merck US
Actavis/Watson & Amgen, USA
Fuji Film & Kyowa Hakko Kirin
DRL & Merck-Serono, Germany - mAbs
Bionovis (Brazil) & Merck Serono

38. Biosimilar Alliances source: Roche 2014

39. nibs (tyrosine kinase inhibitors) - small molecules which may replace mAbs
Axitinib, Pfizer; Cediranib, AZ - cancer
Pazopanib, GSK; Regorafenib, Bayer - cancer
Sorafenib, Bayer(Nexavar) -cancer
Sunitinib, Pfizer; Toceranib, Pfizer - cancer
Vandetanib, AZ; Semaxanaib, Sugen - cancer
Crizotinib (Xalkori) Pfizer, lung cancer, 2013 sales $0.3b with growth >100%
Tofactinib, Pfizer, RA

40. Bayer Comments source: February 2 2014 Bayer

41. Strengths of Manufacturing Biosimilars in Developing Countries
Huge Savings
In out of top 20 pharma products will be biologics

42. Weaknesses of Manufacturing Biosimilar in Developing Countries
Up front investment between $100m and $200m
It takes many years before the products will be available
Existing pharmaceutical manufacturing assets are unlikely to be relevant
It is unfortunate that there is a variation in the nomenclature and regulatory pathway around the world. Biosimilars are sufficiently complex without these extra burdens

43. Opportunities of Manufacturing Biosimilars in Developing Countries
Will allow independence of other countries for their complex medicines
Once in the monoclonal segment other monoclonal antibodies will be available
Substitution by the pharmacist should be allowed by local laws
Timelines for development are so long that most patents will have expired by the time biosimilars are ready

44. Threats of Manufacturing Biosimilars in Developing Countries
12 year rate of return with huge investment
Innovator companies are very protective
Many global alliances between many companies - a single country model difficult
Many products not in public area so there will be greater competition than expected
Branded products in developing countries need a team of salesmen
Doctors don’t like changing ill patients over
Price cuts could be large

45. Some Recommendations for Developing Countries considering Biosimilars
Regulatory pathways - use working pathways
Manufacturing may be based on regional clusters, government agencies or PPP
Product substitution by pharmacists allowed
Financial incentives should be offered instead of direct shareholding
Accept that prices will not fall below a certain level
Nomenclatures of biosimilars should be same

46. Thank You