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A first cycle approval of a generic drug would ensure quick access in the market and eliminate the need for additional communications with the FDA. However, this may not always be possible, as GDUFA I does not provide for adequate communication between industry and the agency during the presubmission and ANDA review stages, Aloka Srinivasan, a principal consultant at PAREXEL International said in a recent FDAnews webinar. Read More
Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More
Amgen is taking Novartis’s biosimilar division to court over alleged patent infringement for seeking FDA approval to produce a biosimilar of its blockbuster therapy Enbrel. Read More
The FTC is suing Endo Pharmaceuticals and several other drugmakers over what it calls the illegal use of pay-for-delay settlements to block the market entry of generic forms of Opana ER and Lidoderm. Read More
An ex-Turing executive took his former employer to task in March, telling lawmakers the drugmaker’s decision to raise the price of Daraprim by 5,000 percent was “unjustified.” Read More
Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon. Read More
The biosimilars market could exceed $390 billion in value over the next five years, but only if nations improve the competitive landscape, according to a new market analysis. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More
Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors incorporate into product labeling information from the reference product labeling. Read More