 |
 |
General Industry
|
 |
 |
 |
|
 |
|
 |
|
 |
|
 |
|
| Title |
|
The Future Battle Between Biopharmaceuticals & Biogenerics |
|
| Sub title |
|
|
|
| Author |
|
BioSeeker |
|
| Publication date |
|
November 2003 |
|
| ISBN |
|
- n/a - |
|
| Pages |
|
95 |
|
| Price |
|
pdf £1530 | print £1560 |
 |
 |
Summary
The use of biotechnology has in short time revolutionised 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. 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.
The Future Battle Between Biopharmaceuticals & Biogenerics lists more than 50 approved recombinant products and their global sales figures. The author, 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 TABLE OF CONTENTS |
 |
Content
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?
|
|
|
|
General Industry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 |
| No additional author information available for this product |
|
|
|
|
|
