Biosimilars - Evolution or Revolution?
A detailed guide to the factors that will shape this vital market, including company strategies, comparability, regulation, the implications for clinical trials and legal issues. With a chapter written by PricewaterhouseCoopers (PwC) looking at the commercial implications for the biotech and pharmaceutical markets.
The market for biotech drugs grew by 18% in 2005 and now exceeds $50 billion - that’s 10% of the global pharmaceutical market at nearly three times the growth rate. Add to that the fact that most biotech drugs are in the fast-growing specialist sector and that they account for more than 25% of the pharmaceutical pipeline (38% in phase III) and it is clear that the market is not going to slow in the foreseeable future.
But the first biotech drugs were launched in the mid 1980s and now patents have expired on drugs worth more than $13 billion. That doesn’t mean that a generic market will develop in the same way that it has for drugs like simvastatin or amlodipine. The nature of biotech drugs means that bioequivalence cannot be shown in the same way that it can for small molecules. Clinical trials will be required and the cost of launching a biosimilar might be as high as $40 million. That’s a lot less than the $1 billion it can cost to launch a new drug, but a lot more than the $2 million it costs to get approval for a normal generic.
In Europe, the EMEA has issued guidelines and the first biosimilar has been approved. In the USA the FDA still has to act, but the direction is becoming clearer. How this market develops will be vital for all the players involved - major pharma, biotechs, generic companies and CROs.
This detailed, 200+ page report, including a chapter on the commercial implications written by Jo Pisani and Yann Bonduelle of PwC explains the issues and looks at the likely outcomes.
As well as the commercial analysis from PwC the report is edited by Dr Nicole Lyscom and written by leading experts in the field including:
- Dr Tim Oldham, VP Business Planning and Operations Effectiveness, Mayne Pharma
- Dr Meena Subramanyam, Senior Director, Clinical science and Technology, Biogen Idec
- Dr Peter H Kalinka, CEO and Managing Director, Accelsiors Group International
- Dr Gabrielle Schaeffner, Principal Consultant, Parexel International, Germany
- Dr Alan Liss, Senior Director, Biotechnology, Duramed Research Inc
- Dr Antonio Maschino, Partner, D Young and Co
- Dr Isla Furlong, D Young and Co
Biosimilars is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.
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- Chapter 1 Strategy Options for Entering the Biosimilar Market
- Tim Oldham PhD, BSc (Hons), LLB (Hons) Acting Head, EMEA Region
- Vice-President, Business Planning and Operations Effectiveness, Mayne Pharma plc, UK
- Chair, Biosimilars and Biotechnology Committee, European Generic Medicines Association
- 1. The Opportunity: Why consider biosimilars at all?
- 1.1 Overview
- 1.2 Biologics and biosimilars defined
- 1.3 Contribution of biologics to modern healthcare: the market potential
- 1.4 Public policy issues: healthcare economics and innovation
- 1.5 Biosimilars: what’s all the fuss?
- 2. Development: What does it actually take to bring a biosimilar to market?
- 2.1 Overview
- 2.2 Experience of the market leaders
- 2.3 Product development
- 2.4 Clinical development
- 2.5 Manufacturing capacity
- 2.6 Regulatory strategy
- 2.7 Pharmacovigilance
- 2.8 Making the trade-offs: cost, time and risk
- 2.9 Proving comparability: is it strictly necessary?
- 3. Working Out The Profit Potential: What are the conditions to make an economic return and how can they be maximised?
- 3.1 Overview
- 3.2 Minimum efficient market size
- 3.3 Target market drivers
- 3.4 Market share drivers
- 3.5 Sales and marketing cost drivers
- 3.6 Price drivers
- 3.7 Legal costs
- 3.8 Has risk reduction won over healthcare economics?
- 4. Market Structure: Players and Issues
- 4.1 Overview
- 4.2 Regulatory frameworks and their evolution
- 4.3 Post-authorisation issues
- 4.4 Big biotech positions and strategies
- 4.5 Biosimilar developers
- Chapter 2 Product Similarity for Biosimilars
- Meena Subramanyam PhD Senior Director, Clinical Science and Technology, Biogen Idec Inc., USA
- 1. Impact of Manufacturing Process on the Biosimilar Product
- 1.1 Demonstration of pharmaceutical equivalence
- 1.2 Requirements for demonstrating "similarity"
- 1.3 Impact of changes to cell culture process
- 1.4 The "tool kit"
- 2. Preparation of a Comparability Package to the Regulators
- 2.1 Quality data -The EMEA guidance
- 2.2 The Reference Standard
- 2.3 Non-clinical data
- 2.4 Clinical data
- 3. Approved Biosimilars - Similarity Considerations for Specific Products
- 4. How Similar is "SIMILAR"
- 5. The Future
- 6. Acknowledgement
- Chapter 3 Clinical Trials for Biosimilars
- Peter H Kalinka PhD CEO and Managing Director, Accelsiors Group International
- Instructor for Clinical Development of Pharmaceuticals and Biologics, Advanced Biotechnology Studies, Johns Hopkins
- University
- 1. Requirements for a Robust Clinical Protocol
- 1.1 Introduction
- 1.2 Clinical protocol design
- 1.3 Clinical case studies
- 1.4 Summary and Conclusion
- 2. Factors Affecting Size of Clinical Study
- 2.1 Literature Data
- 2.2 Valuable Information
- 3. Clinical Demonstration of Bioequivalence
- 4. Determination of Clinical and Surrogate End-points
- 5. Summary and Conclusion
- Chapter 4 Regulatory Issues - European Perspective
- Gabriele Schaeffner, PhD Principal Consultant, Parexel International GmbH, Germany
- 1. Regulatory Considerations for Clinical Trials
- 1.1 How the clinical programme forms part of a risk-based comparability assessment
- 1.2 ICH recommended design, scope and scale to provide sufficient safety and efficacy
- 1.3 Selection of comparators for various products
- 1.4 Where to carry out the clinical trial
- 1.5 Clinical Risk Management
- 1.6 Impact of clinical testing on timelines and cost
- 1.7 To what extent can ‘abbreviated use’ be applied?
- 1.8 Is it necessary to conduct a clinical trial for every indication?
- 1.9 Conclusion
- 2. EU Current Guidance and Draft Guidance Explained
- 2.1 EU directives to date
- 2.2 Guidance documents, adopted guidelines, drafts for consultation and conceptpapers
- 2.3 CHMP guidance on quality issues and non-clinical and clinical issues
- 2.4 Implications of ICH Q5E for the industry
- 2.5 Concepts of biosimilarity and essential similarity explained: which is most appropriate and why?
- 2.6 Focus on products: recombinant human insulin, somatotropin, human granulocyte colony stimulating factor and recombinant human erythropoietin
- 2.7 Update from EMEA/DIA meeting in Paris in December 2005
- 2.8 Future outlook for marketing authorisation applications: will this remain a barrier to success?
- 2.9 Predictions for future regulatory guidance and directives
- 2.10 Conclusion
- 3. Practical Considerations when dealing with the European Regulators
- 3.1 How the case-by-case approach works in practice
- 3.2 Experiences with essential similarity issues
- 3.3 How the Centralised Procedure is working in practice
- 3.4 How the generics manufacturer can benefit from the Centralised Procedure
- 3.5 Where applicants go wrong / Lessons that can be learnt with hindsight
- 3.6 Recommended strategies for success
- 3.7 When advice from the regulators should be sought
- 3.8 Content of a Scientific Advice Package
- 3.9 Without an ‘abridged’ application, what short cuts are possible?
- 3.10 Features of Omnitrope that counted in its favour with the EMEA
- 3.11 Risk management strategy
- 3.12 Conclusion
- 4. Role of the European Commission in the route to Marketing Authorisation
- 4.1 Current and future legal framework for biosimilars
- 4.2 Consequences of the ‘Pharma Review’ for the industry
- 4.3 Application of the Bolar provision to biosimilars - details of the clause
- 4.4 Required studies and trials
- 4.5 Implications of the Commission’s ruling on Omnitrope for the industry
- 4.6 To what extent does the use of published data and ‘well established use’ render an
- application susceptible to challenge?
- 4.7 Proof-of-principle: Does this work in practice? Will it be necessary to conduct trials
- for every indication?
- 4.8 Conclusion
- 5. Regulatory Case Studies and Precedents in the EU
- 5.1 Introduction
- 5.2 Analysis of the data submitted for successful approval of rhGH containing similar products (Omnitrope, Valtropin)
- 5.3 Analysis of the data submitted for Alpheon
- 5.4 Conclusion
- 6. Routes to Regulatory Approval in the EU
- 6.1 The principle routes
- 6.2 Routes for generic medicinal products and similar biological medicinal products
- Chapter 5 Regulatory Issues - US Perspective
- Alan Liss, PhD Formerly Senior Director, Biotechnology, DRI, USA
- 1. FDA’s Stand in the Absence of Formal Regulatory Guidance
- 2. Anticipated FDA Draft Guidance
- 3. Regulatory Case Studies and Precedents in the US
- 3.1 Comparability Protocols
- 3.2 The FDA's approval of Avonex, a Biogen/Idec product
- 3.3 Insulins
- 4. Routes to Regulatory Approval in the US and the Rest of the World
- 4.1 A path forward
- Chapter 6 Legal Issues Antonio Maschio, PhD
- Partner, D Young & Co, UK Isla Furlong, PhD D Young & Co, UK
- 1. Determination of the Patent Environment / Freedom to Operate
- 1.1 Introduction
- 1.2 What is patentable?
- 1.3 How to conduct freedom-to-operate determinations
- 1.4 What can you do before a patent expires?
- 2. The Law as Defined by Legal Precedent: Case Studies
- 2.1 Sandoz GmbH v Roche Diagnostics GmbH (EWHC Ch 1313; http://www.bailii.org/ew/cases/EWHC/Ch/2004/1313.html) (Inventive Step)
- 2.2 Kirin Amgen Inc. & Others v Hoechst Marion Roussel Limited & Others (UKHL 46; http://www.bailii.org/uk/cases/UKHL/2004/46.html)
- 3. Strategy for Overcoming the Legal Obstacles and 'Clearing the Way' for Development
- 3.1 Introduction
- 3.2 Strategies for early development of biosimilars - what can be done before the patent has expired?
- 3.3 Summary
- Chapter 7 Opportunities and Barriers in the Biosimilars Market: Evolution or Revolution for Generics Companies?
- Jo Pisani & Yann Bonduelle
- Pharmaceutical Strategy Consultants
- PricewaterhouseCoopers
- 1. Summary
- 2. An Introduction to the Biopharmaceutical Market
- 3. Commercial Drivers for Biosimilars
- 3.1 Pricing Strategy
- 3.2 Erythrpoietin
- 3.3 Granulocyte-colony stimulating factors (G-CSF)
- 3.4 Interferon alpha
- 3.5 Interferon beta
- 3.6 Human growth hormone
- 3.7 Recombinant human insulin
- 4. Country Market Opportunities
- 4.1 German
- 4.2 United Kingdom
- 4.3 Franc
- 4.4 Italy
- 4.5 Spain
- 4.6 United States
- 5. Developing New Competencies
- 6. Summary
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