Elsevier Business Intelligence announces the publication
of a new Special Report:

Understanding the Legislative, Regulatory and Business Implications of Follow-On Biologics

Contains previously published articles from"The Pink Sheet," “The Pink Sheet" DAILY and The RPM Report

With the patent cliff looming and pipelines dangerously dry, most of the biopharma industry, from generics manufacturers like Teva to biopharmas like Merck and Pfizer to start-up biotech, is focusing on follow-on biologics. But the entire space, including everything from initial development strategies to future legislation, is still up in the air, making business planning a nightmare.

In this Special Report, you get a complete road map of the potential new FOB market in the U.S. from initial investments to the probable shape of the regulatory pathway, to take the guesswork out of your business strategy.

This detailed 28-page report includes critical information for business development, R&D, drug development and regulatory executives; financial advisors, investors and consultants; and regulators and policy makers.

Prepared by Elsevier Business Intelligence’s expert analysts, the report spotlights the companies already preparing to enter the space, their business strategies, priorities of the agencies that will shape the regulatory pathway and the potential look of FOB legislation.

This Special Report reveals:

• Which companies are already in the race to FOBs, who isn’t, and how to tell if the FOB space is right for you.
• How to predict which brands will be FOB-worthy
• Both the current state and the future of the European biosimilars market
• How the battle is shaping up over exclusivity rights
• FOB provisions that are in – and out – of the pending House health care reform bill, HR3200
• PhRMA’s position on FOB legislation, and why not all members are on board

… and much more

What’s the worst that could happen?

The FOB politics of the Roche-Genentech deal are revealing, not least because it made public Genentech’s internal estimates that follow-on biologics will reduce an innovator brand’s revenues by approximately 30 percent in the two years after launch. But this is just the tip of the iceberg for policy makers debating the critical exclusivity period in FOB legislation.

Picking the winners

Identifying potentially profitable FOBs will be much harder than traditional business development. You’ll have to guess at the state of the product’s market much farther down the road, extra costs associated with surveillance and physician education; and immunogenicity issues, among many other factors.

The gorilla in the living room

Health care reform: Will FOBs get a big boost from new legislation, or will they be an afterthought? It all depends on whose data you look at and how much savings you estimate from generics in the overall scheme of reform. If you’re thinking of developing FOBs --or if you have products that should be at a competitive risk -- you need to get the latest on how health care reform could incorporate follow-on biologics, and what it means for your business.

These are just some of the issues and actionable guidance included in this report. And it could only be delivered by Elsevier Business Intelligence, provider of the most in-depth, accurate, expert business intelligence in health care today.