Market Report Source

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

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