The Future Battle Between Biopharmaceuticals and Biogenerics

Published by: BioSeeker Group AB

Published: Oct. 30, 2003 - 95 Pages

Table of Contents

Methodology

Information Sources

Analysts

Table Of Contents

Introduction

Leading Issues, Immunogenicity And Efficacy.

Regulatory Issues And Hurdles

Present Position Of FDA And EMEA.

European Generic medicines Association

Case By Case Study Give Guidance

Demonstrating Therapeutic Equivalence

Tools Available To Manage Biologics.

Can Different Cell Lines Be Equivalent?

Is There Room For Comparability Studies?

Are there regulatory precedents?

Clinical Concerns, Likely To Be Required.

The First Wave Of Biologics, Off Patent

Biogeneric Companies Planning To Stake An Early Claim.

Growth Hormones And Insulin Pave The Way

Follow On Cytokines Do They Stand A Chance

Colony Stimulating Factor

Epogen - The Big Market Opportunity

Manufacturing Challenges

Preventing Generic Competition

Litigation Against Generic Makers

Some Aspects About Biogenerics From An IP-View

Making Biogeneric Products Obsolete

Marketing Follow On Biologics

Biologics Cost; Facilities in Asia and Eastern Europe

Competition; Prize Or Product

What Price Is To Be Expected

Conclusion

Index

Disclaimer

Liability

Completeness

Abbreviation

Abstract

BioSeeker has analysed the opinions and arguments held by producers of biopharmaceuticals or generic-drug makers as well as regulatory authorities, in order to gain insight on how the near future guidelines will develop. We have reviewed the positions of the FDA and the EMEA, the views on regulatory precedent cases from the biologics industry, the possible route of a comparability study approval, the scope of clinical trial necessary, and the scientific and regulatory issues that must be addressed before future guidelines can be initiated.

In this report, BioSeeker Group has listed more than 50 approved recombinant products and their global sales figures. Furthermore, BioSeeker has looked at expiring patents and the biogeneric products that are likely to get a head start in Europe and the US. The most active generic companies and their selected recombinant biologics project portfolio have been evaluated. This report also evaluates the key challenges faced by the generic companies, the expected prize of the second entry biologics, as well as the competitive strategies available to each respective party as they compete for market shares. To gain background and updated information, as well as standpoints from current leaders in this field, BioSeeker has interviewed a number of key management officers in the industry, key personnel of regulatory authorities, interest organizations, investors and members of the academic research community.

The use of biotechnology has in short time revolutionized the pharmaceutical industry. Today, approximately 20 years since the first biopharmaceutical products were patented, patent protections for biologics are starting to expire. This has created a new marketplace to be exploited by generic competition. According to IMS Healthcare, the world market for biopharmaceuticals is approximately $20 billion. Thus, if biogenerics attain a 10-15% saturation, similar to that of the standard generic market, there is a potential market of $2 billion. Put simply, opportunities abound for the first players poised to enter the generic biopharmaceutical field. However, one of the main obstacles for the biogeneric drug market is a lack of clear regulatory rules for approving biogeneric versions.

With growing pressure on capital health to make drugs more affordable, regulatory guidelines are necessary. Although some biopharmaceuticals have already lost their patent protection and are open to generic competition, the Biotech Industry Organization argues that producing biologics is still such a complex task that generic firms should have to prove their safety and effectiveness. This technical complexity coupled with the lack of regulatory pathways limits the number of generic drug producers capable of winning the battle against pharmaceuticals.

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