Abstract
Overview
Introduction
The drive for increased cost savings by healthcare providers is increasing the
focus on boosting the biosimilar market. With a regulatory approval pathway in
place in Europe and substantial guidelines to support biosimilar development,
the European biosimilars market is significantly more advanced than the US,
where plans for a biosimilar regulatory approval pathway have stalled.
Scope
- Introduction to why biosimilars development is being pushed in Europe and
the US
- In-depth analysis of the US and European biosimilar regulatory environment
- Overview of the success of biosimilar approvals in the US and European
markets
- Identification of future trends shaping biosimilar regulatory environment
evolution
Report Highlights
Although the FDA was relatively pro-biosimilars from 1999-2004, the release of
regulatory guidelines for biosimilars has stalled significantly since the
resignation of Commissioner McClellan; furthermore, the FDA' s switch to a
stance of issuing broad biosimilars guidance first will require Congress
action, delaying biosimilar launches further.
The European regulatory environment is considerably more favorable for
biosimilar developers, with the release of a range of directives and
guidelines set to help guide biosimilar development; however, more clarity is
needed to clear up ambiguities in legislation and more strongly shape
biosimilar approvals.
In the future, the evolution of the biosimilars environment will largely
depend on whether the pro-biosimilars or the anti-biosimilars faction has
greatest influence over the regulatory authorities; in the US, the
pro-innovator biologics faction is currently more powerful, while in Europe,
the pro-biosimilars faction has had greater success.
Reasons to Purchase
- Understand the key regulatory frameworks for biosimilar approvals in the
US and Europe
- Build an understanding of how biosimilars have fared in the US and Europe
- Gain insight into how the biosimilars market is set to evolve in the future
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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