Home | Publications | Research (R&D) | Clinical Trials place holder
place holder place holder

Clinical Trials


Enabling Biogenerics

Exploiting Comparability to Limit Clinical Trial Needs

Publication Date   October 2006
Publisher   IDC
Product Type   Brief
Pages   4
ISBN Number   not applicable
Product Code   IDC090
Ask a question about this product?

Price £270.00

approximately: $414 | €318

Summary


This perspective describes analyst perspectives in response to recently proposed legislation to enable the approval of generic biological drugs (biogenerics) by the U.S. Food and Drug Administration (FDA). The proposed legislation aspires to provide competitive pressure to develop generic alternatives to FDA-approved biological drugs that have exhausted patent protections with the overall goal of decreasing drug costs for consumers.

Content


In This Perspective

Overview
Using Technological Innovation to Establish Comparability
Quantitative Molecular Analytical Tests
Advanced Technology Solutions

Learn More

Related Research