Biosimiliars
Protein copies clear hurdle: Green light for U.S. approval pathway accelerates the emergence of biosimilars, but the market’s road to fast lane is still uncertain.
By Michael D. Christel

E-solutions for clinical trials
With still no official electronic data standard in place, sponsors and FDA work to sync submission strategies.
By Ed Silverman



Editor's Page
As a new study points out that price-slashing affects drug companies' ability to innovate, the effect of biosimilars legislation on innovator companies will be keenly observed
By Christiane Truelove

R&D Business
Abbott Laboratories' $3.7 billion acquisition of Indian pharmaceutical company strengthens drugmaker's emerging markets push.
By Colette Pilkus

Drugs in Development
Merck & Co. launches pioneering cancer trials network to discover new oncology treatments.
By Colette Pilkus

Filed for Approval
An FDA advisory panel recommends approval of Novartis drug candidate fingolimod as first oral therapy for multiple sclerosis.
By Colette Pilkus 

IP disclosure complicates biosimilars picture
As FDA begins to mold the framework for the recently passed regulatory approval pathway for biosimilars, one area likely to be followed intently will be how authorities will ultimately enforce the mechanism for intellectual property disclosure concerning follow-on biologics.
By Michael D. Christel

Q&A: Biosimilars field a work in progress
Greg Dombal, managing partner, Halloran Consulting Group, spoke with R&D Directions about the new momentum for the biosimilars market, the largely uncharted territory for these products, and the industry's quest to better understand the science behind follow-on biologics.
By Michael D. Christel