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Biosimilars: Regulatory Issues - Europe continues to make strides while the US lags behind

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 - page 4
  • Scope of the report - page 4
  • Key findings - page 4
  • Key definitions - page 5
• CHAPTER 2 OVERVIEW OF BIOSIMILARS AND HOW REGULATORY ISSUES IMPACT THE MARKET - page 10
  • The potential for cost savings drives the development of a biosimilars regulatory approval pathway - page 11
  • Recombinant proteins are the key target for biosimilar developers - page 12
  • The complexity of the biosimilars regulatory environment is a key factor restricting biosimilars developers - page 13
• CHAPTER 3 THE POWER BALANCE BETWEEN PRO-BIOSIMILARS AND ANTI-BIOSIMILARS SHAPES MARKET EVOLUTION - page 17
  • The current situation: the US lags further behind as the issue becomes more politically charged - page 17
    • Currently, the European environment is more pro-biosimilars than the US - page 17
    • 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 - page 18
  • 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 - page 19
    • There are significant difficulties with demonstrating comparability - page 19
      • Why is comparability such a problem? - page 19
      • Comparability is therefore a key issue for biosimilars, and stringent requirements boost development costs - page 21
      • The importance of choosing the right reference product to demonstrate comparability - page 21
      • Although there are extensive comparability requirements, it is important that biosimilar developers seek guidance from European and US regulatory bodies - page 22
      • Problems with establishing 'sameness' means that generic substitution is unlikely to be relevant for biosimilars - page 22
    • Does the process make the product? And if so, are biosimilar developers asking regulatory bodies to act illegally? - page 23
      • 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 - page 24
      • It is becoming easier to demonstrate comparability - page 25
      • Safety remains the key to determining comparability - page 25
• CHAPTER 4 THE REGULATORY ENVIRONMENT FOR BIOSIMILARS IN THE US - page 26
  • Introduction to the approval process for generics in the US and how biosimilar approvals fit into this process - page 27
  • Key events shaping the development of a biosimilars approval pathway: the FDA changes tack in 2004, delaying biosimilars market entry - page 29
    • From 2001 to 2004, the FDA prioritized developing guidance for biosimilars, despite attacks from innovator developers - page 29
    • The resignation of McClellan in 2004 led to delays in the development of guidance for biosimilars - page 31
      • FDA workshops do little to accelerate progress, while the development of a regulatory pathway stalls - page 32
      • 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 - page 33
      • Innovator biologics companies retaliate by issuing a white paper, hoping to stall the process further - page 34
    • Despite significant resistance from innovator biologics companies, some progress in the development of a biosimilar regulatory process is now being made in the US - page 35
      • Hatch and Waxman urge the FDA to provide guidelines on approvals of biosimilars of NDA biologics - page 36
      • Citizen petition lobbies the FDA to provide requirements for the approval of biosimilar versions of NDA biologics - page 36
      • The 'Access to Life-Saving Medicine' Act represents the largest stride in developing a biosimilars approval pathway - page 37
      • While progress in developing a biosimilars regulatory pathway stalls, biosimilar developers are using the full submission pathway - page 40
  • The battle to get Omnitrope approved: the biosimilar submission and approval record at the FDA - page 41
    • Is Omnitrope really the first follow-on biologic to be approved? - page 41
    • 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 - page 42
• CHAPTER 5 THE REGULATORY ENVIRONMENT FOR BIOSIMILARS IN EUROPE - page 44
  • A range of directives and guidelines are used to shape the biosimilar regulatory environment in Europe - page 45
    • Overarching directives and guidelines shaping biosimilar approvals - page 48
      • The Pharma Review 2001 kicks off biosimilar approval pathway discussion - page 48
    • Product class guidelines help to guide biosimilar approvals for the major recombinant protein classes - page 50
    • Comparability guidelines provide essential information on how to demonstrate comparability between biosimilars and innovator biologics - page 52
    • Quality guidelines developed to help innovator drugs companies get around inter-batch variability can be used by biosimilar developers to show comparability - page 53
    • Non-clinical and clinical issues help shape what type of data is included in the biosimilar submission dossier - page 53
    • Additional legislation impacting biosimilars: Directive 2004/27/EC redefines exclusivity and affirms the Bolar provision - page 54
  • Biosimilar submission and approval record at the EMEA: Europe has been a more favorable environment for biosimilar approvals - page 55
• CHAPTER 6 BIBLIOGRAPHY - page 56
  • Publications and online articles - page 56
  • Datamonitor resources - page 58
• CHAPTER 7 GLOSSARY - page 59
  • Glossary of terms - page 59


• List of Tables
• Table 1: Differences in the development and regulatory approval pathway between biosimilars and small molecule generics - page 14
• Table 2: Adopted guidelines for European biosimilars, by submission/adoption date, 2003-06 (the most recent are first) - page 45
• Table 3: Different product classes have different efficacy and safety requirements - page 51


• List of Figures
• Figure 1: The biologics market has grown at a stronger rate than the overall market - page 11
• Figure 2: Biosimilar development could take six to nine years - page 15
• Figure 3: A range of situations require comparability testing - page 20
• Figure 4: The FDA were pro-biosimilar development in the five-year period, from 1999 to 2004 - page 31
• Figure 5: The FDA became anti-biosimilar development in the two-year period from 2004 to 2005 - page 35
• Figure 6: The Access to Life-Saving Medicine Act rewards biosimilar development using three key incentives - page 39
• Figure 7: Key biosimilar regulatory guidelines - page 47

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