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Published by: Pharmalicensing Ltd.
Published: May. 1, 2004 - 71 Pages
Table of Contents
1. Executive Summary
1.1. What will determine success?
2. Introduction
2.1. What does 'biogenerics' mean?
2.2. Geographic issues and biogenerics
2.2.1. What geographic areas are covered?
2.2.2. The current position for biogenerics - markets outside the West
2.2.3.Why approach Western markets?
2.3. Which are the biogeneric players?
2.4. How will biogenerics companies impact Western markets?
2.5. When will biogenerics impact Western markets?
2.5.1. Europe - the first Western market for biogenerics?
2.5.2. The US - closer on the heels of the EU?
3. Can you make the product?
3.1. Manufacturing barriers
3.1.1. Biopharmaceuticals - difficult products
3.1.2. Some molecules are easier to make than others
3.1.3. Production costs are generally low
3.2. Successful strategies for overcoming manufacturing barriers
Case study 3.1: Acquisition of biopharmaceutical expertise
Case study 3.2: Collaboration to gain access to production technology
Case studies 3.3 and 3.4: Gain production expertise outside EU
Case studies 3.5 and 3.6: Move production facilities inside the EU
4. Can you get the product to market?
4.1. Regulatory barriers
4.1.1. The EU position
4.1.1.1. Full clinical trials requirement or the acceptance of a shortened route?
4.1.1.2. Summary of the European position
Case studies 4.1 and 4.2: The regulatory position in Europe
4.2. The position in the US
Case study 4.3: The regulatory position in the US
4.3. Innovator strategies
4.3.1. Patent litigation
Case study 4.4: Innovator product protection through patent litigation
4.3.2. Second-generation products
Case study 4.5: Second-generation products
4.4. Successful strategies for getting products to market
Case studies 4.6 and 4.7: Gaining experience in less regulated markets
5. Can you make a profit?
5.1. Barriers to a profitable business
5.1.1. Marketing spend required
5.1.2. Gaining clinician acceptance
5.1.3. Appropriate pricing for biogeneric products
5.2. Strategies for profitability
5.2.1. Pick the right partner/acquisition/collaboration
Case studies 5.1 and 5.2: Focus on partnering
Case study 5.3: Build on significant market presence already in Europe
Case study 5.4: Acquire a market presence in Europe
Case study 5.5: Acquire marketing company in Europe
5.2.2. Pick the right product
Case study 5.6: Recombinant human EPO (rh EPO)
Case study 5.7: Recombinant human growth hormone (rh GH)
Case study 5.8: Recombinant human IFN alpha
Case study 5.9: Recombinant human G-CSF and GM-CSF
6. The first successful products?
6.1. What are the characteristics of the successful biogenerics company?
6.2. What are the characteristics of a successful biogeneric product?
6.3. When are biogenerics likely to come to market?
7. Selected company profiles
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
AbstractWhat will determine success?
Development of biogeneric molecules for sale in the potentially highly lucrative US and Western European markets depends on the ability to answer three key questions positively:
- Can you make the product consistently to GMP and demonstrate its essential similarity to originator products?
- Having made the product, can you get it to market?
- Having accessed the market, are you able to make a profit from the sales of your biogeneric product?
This report focuses on the specific strategies adopted by companies involved in the biogenerics arena, asking:
- Why are specific strategies likely to be effective?
- Why are particular companies more likely to be successful in the race to enter and profit from the biogenerics market in Europe and the US?
Biogenerics companies tend to adopt four main approaches. Often any one company will take more than one approach:
- Focus on strategic partnerships.
- Expand through acquisition.
- Supply into developing markets initially, followed by Europe and eventually the US.
- Develop second-generation products.
For any of these approaches to be successful, biogenerics companies will need to:
- Be well financed
- Possess sufficient technical capability, and be operating to Western GMP standards
- Be sufficiently focused, usually on only one or two products, since they will need to understand the market segment they are entering and have sufficient finances to operate in the chosen market
- Have developed or be developing effective working relationships with the regulatory authorities
- Have a strong market presence
Whichever products these companies choose to develop they need to be certain that:
- There is no intellectual property barrier
- The product's market characteristics are such that it could deliver worthwhile profit to the producer
- Is the market big enough?
- What is the competition like?
- Are there many entrenched players in the market already?
- Are there many other biogenerics players entering this market?
- Are biogeneric players already producing this product outside the Western markets?
- How likely are other biogenerics players to enter the market?
The earliest that biogenerics are likely to come to market is 2006, for the simpler products, such as G-CSF, rh GM-CSF and first-generation rh EPOs. However there is significant potential for delay along the route from:
- Regulators wrestling with the application of new rules. An example of this is Omnitrop (recombinant human growth hormone), which the Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Agency for the Evaluation of Medicinal Products (EMEA), recommended for approval in Europe in June 2003. Omnitrop was ultimately rejected by the European Commission in April 2004.
- Innovators employing delaying tactics aimed at preventing biogenerics from taking shorter routes to approval.
- Development of second-generation products that are significantly better than the originals, meaning that original products are unlikely to take significant market share.
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