Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
- Key definitions
- CHAPTER 2 OVERVIEW OF BIOSIMILARS AND HOW REGULATORY ISSUES IMPACT THE
MARKET
- The potential for cost savings drives the development of a biosimilars
regulatory approval pathway
- Recombinant proteins are the key target for biosimilar developers
- The complexity of the biosimilars regulatory environment is a key factor
restricting biosimilars developers
- CHAPTER 3 THE POWER BALANCE BETWEEN PRO-BIOSIMILARS AND ANTI-BIOSIMILARS
SHAPES MARKET EVOLUTION
- The current situation: the US lags further behind as the issue becomes
more politically charged
- Currently, the European environment is more pro-biosimilars than the US
- The stronger position for innovator biologics companies in the US
means that greater political pressure is required to support the
development of a biosimilars regulatory approval pathway
- Whoever wins the battle between the pro-biosimilars faction and the
anti-biosimilars faction will significantly impact the way that the
biosimilars market evolves in the US and Europe
- There are significant difficulties with demonstrating comparability
- Why is comparability such a problem?
- Comparability is therefore a key issue for biosimilars, and
stringent requirements boost development costs
- The importance of choosing the right reference product to
demonstrate comparability
- Although there are extensive comparability requirements, it is
important that biosimilar developers seek guidance from European and US
regulatory bodies
- Problems with establishing ' sameness' means that generic
substitution is unlikely to be relevant for biosimilars
- Does the process make the product? And if so, are biosimilar
developers asking regulatory bodies to act illegally?
- In the past, innovator drug companies have been happy to support the
argument that biologics manufactured in entirely different ways are the
same as the innovator drug
- It is becoming easier to demonstrate comparability
- Safety remains the key to determining comparability
- CHAPTER 4 THE REGULATORY ENVIRONMENT FOR BIOSIMILARS IN THE US
- Introduction to the approval process for generics in the US and how
biosimilar approvals fit into this process
- Key events shaping the development of a biosimilars approval pathway:
the FDA changes tack in 2004, delaying biosimilars market entry
- From 2001 to 2004, the FDA prioritized developing guidance for
biosimilars, despite attacks from innovator developers
- The resignation of McClellan in 2004 led to delays in the development
of guidance for biosimilars
- FDA workshops do little to accelerate progress, while the
development of a regulatory pathway stalls
- Biosimilar developers turn to the USP to help find a way to
accelerate the development of a regulatory pathway for biosimilars of
NDA biologics by characterizing comparability between biosimilars and
innovator biologics
- Innovator biologics companies retaliate by issuing a white paper,
hoping to stall the process further
- Despite significant resistance from innovator biologics companies,
some progress in the development of a biosimilar regulatory process is now
being made in the US
- Hatch and Waxman urge the FDA to provide guidelines on approvals of
biosimilars of NDA biologics
- Citizen petition lobbies the FDA to provide requirements for the
approval of biosimilar versions of NDA biologics
- The ' Access to Life-Saving Medicine' Act represents the largest
stride in developing a biosimilars approval pathway
- While progress in developing a biosimilars regulatory pathway
stalls, biosimilar developers are using the full submission pathway
- The battle to get Omnitrope approved: the biosimilar submission and
approval record at the FDA
- Is Omnitrope really the first follow-on biologic to be approved?
- Omnitrope' s approval in the US: it may not have been the first
follow-on biologic approved under Section 505(b)(2) but it has created the
greatest interest
- CHAPTER 5 THE REGULATORY ENVIRONMENT FOR BIOSIMILARS IN EUROPE
- A range of directives and guidelines are used to shape the biosimilar
regulatory environment in Europe
- Overarching directives and guidelines shaping biosimilar approvals
- The Pharma Review 2001 kicks off biosimilar approval pathway
discussion
- Product class guidelines help to guide biosimilar approvals for the
major recombinant protein classes
- Comparability guidelines provide essential information on how to
demonstrate comparability between biosimilars and innovator biologics
- Quality guidelines developed to help innovator drugs companies get
around inter-batch variability can be used by biosimilar developers to
show comparability
- Non-clinical and clinical issues help shape what type of data is
included in the biosimilar submission dossier
- Additional legislation impacting biosimilars: Directive 2004/27/EC
redefines exclusivity and affirms the Bolar provision
- Biosimilar submission and approval record at the EMEA: Europe has been a
more favorable environment for biosimilar approvals
- CHAPTER 6 BIBLIOGRAPHY
- Publications and online articles
- Datamonitor resources
- CHAPTER 7 GLOSSARY
- Glossary of terms
- List of Tables
- Table 1: Differences in the development and regulatory approval
pathway between biosimilars and small molecule generics
- Table 2: Adopted guidelines for European biosimilars, by
submission/adoption date, 2003-06 (the most recent are first)
- Table 3: Different product classes have different efficacy and safety
requirements
- List of Figures
- Figure 1: The biologics market has grown at a stronger rate than the
overall market
- Figure 2: Biosimilar development could take six to nine years
- Figure 3: A range of situations require comparability testing
- Figure 4: The FDA were pro-biosimilar development in the five-year
period, from 1999 to 2004
- Figure 5: The FDA became anti-biosimilar development in the two-year
period from 2004 to 2005
- Figure 6: The Access to Life-Saving Medicine Act rewards biosimilar
development using three key incentives
- Figure 7: Key biosimilar regulatory guidelines
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