Strategies for Biogeneric Success

1. Executive Summary 5

1.1. What will determine success? 5

2. Introduction 7

2.1. What does 'biogenerics' mean? 7

2.2. Geographic issues and biogenerics7

2.2.1.What geographic areas are covered? 7

2.2.2.The current position for 7

2.2.3.Why approach Western markets? 7

2.3. Which are the biogeneric players?9

2.4. How will biogenerics companies impact 11

2.5. When will biogenerics impact Western 12

2.5.1.Europe the first Western market for 12

2.5.2.The US closer on the heels of the 13 EU?

3. Can you make the product? 15

3.1. Manufacturing barriers 15

3.1.1.Biopharmaceuticals difficult products 15

3.1.2.Some molecules are easier to make 15 than

3.1.3.Production costs are generally low 15

3.2. Successful strategies for overcoming 16

Case study 3.1:Acquisition of biopharmaceutical 16

Case study 3.2:Collaboration to gain access 17

Case studies 3.3 and 3.4:Gain production 17

Case studies 3.5 and 3.6:Move production 18

4. Can you get the product to20

4.1. Regulatory barriers 20 4.1.1.The EU position 20

4.1.1.1.Full clinical trials requirement or 21 shortened route?

4.1.1.2.Summary of the European position 22

Case studies 4.1 and 4.2:The regulatory 22

4.2. The position in the US 23 Case study 4.3:The regulatory position24 in the

4.3. Innovator strategies 25 4.3.1.Patent litigation 25 Case study 4.4:Innovator product protection25

4.3.2.Second-generation products 26 Case study 4.5:Second-generation products 26

4.4. Successful strategies for getting28

Case studies 4.6 and 4.7:Gaining experience in 28

5. Can you make a profit? 29

5.1. Barriers to a profitable business29

5.1.1.Marketing spend required 29

5.1.2.Gaining clinician acceptance

5.1.3.Appropriate pricing for biogeneric30

5.2. Strategies for profitability 30

5.2.1.Pick the right partner/acquisition/collaboration 30

Case studies 5.1 and 5.2:Focus on partnering 30 Case study

5.3:Build on significant market31 Case study

5.4:Acquire a market presence in32 Case study

5.5:Acquire marketing company in32

5.2.2.Pick the right product 32 Case study

5.6:Recombinant human EPO (rh EPO) 32 Case study

5.7:Recombinant human growth 34hormone Case study

5.8:Recombinant human IFN alpha 35 Case study 5.9:Recombinant human G-CSF36 and GM-

6. The first successful products? 37

6.1. What are the characteristics of the 37

6.2. What are the characteristics of a37

6.3. When are biogenerics likely to come to 38

7. Selected company profiles 39

7.1. BioPartners

7.1.1.Biogenerics activity

7.1.2.Products

7.2. BioGeneriX

7.2.1.Biogenerics activity

7.2.2.Partnerships/alliances

7.3. BioTechnology General

7.4. Cangene

7.4.1.Biogenerics activity

7.4.2.Products

7.4.3.Production technologies

7.5. Dragon Pharmaceuticals

7.5.1.Biogenerics activities

7.5.2.Strategy

7.5.3.Products

7.5.4.Production technologies

7.6. Dr Reddy's Laboratories (DRL)

7.6.1.Biogenerics activities

7.6.2.Products

7.7. E Merck

7.8. GeneMedix

7.8.1.Biogenerics activity

7.8.2.Strategy

7.8.3.Regulatory approach

7.8.4.Products

7.8.5.Partnerships

7.9. Ivax Corp

7.10. Novartis (Sandoz,Biochemie)

7.10.1.Biogenerics activity

7.10.2.Strategy

7.10.3.Products

7.11. Pliva

7.11.1.Biogenerics activities

7.12. Prolong Pharmaceuticals

7.12.1.Biogenerics activity

7.12.2.Strategy

7.12.3.Products

7.13. Ranbaxy Laboratories

7.14. Rhein Biotech

7.15. Savient Pharmaceuticals

7.15.1.Biogenerics activity

7.15.2.Strategy

7.15.3.Products

7.16. Shantha Biotechnics

7.16.1.Biogenerics activity

7.16.2.Products

7.16.3.Collaborations

7.17. Sicor

7.17.1.Biogeneric activities

7.17.2.Products

7.17.3.Production technology

7.18. Stada

7.19. Biogenerics (now Bioceuticals)

7.19.1.Biogeneric activities

7.20. Teva Pharmaceuticals

7.20.1.Biogeneric activity

7.21. Transkaryotic Therapies

7.21.1.Biogeneric activities

7.21.2.Products

7.22. Wockhardt

7.22.1.Biogenerics activity

7.22.2.Acquisitions

7.22.3.Alliances

7.22.4.Products

8. Author biographies

8.1. Jim Furniss MA

8.2. Helen Durrant BSc (Hons)

9. Order form