Humanizing Animals for Immuno-Oncology
Success in Humanizing Mice Has Inspired Similar Efforts in Rats, Pigs, and Other Animals
Transcript-Savvy Discovery Is a Smart Bet
Drug Developers Are Finding Ways to Bend the Transcriptome to Their Will
10 Takeover Targets of 2016
Which Biopharmas Do Wall Street Watchers View As Top Buyout Candidates?
Molecular Dx Has Your (Copy) Number
CNV Detection and Analysis Tools Are Being Used To Fill Genetic Diagnostic Gaps
Biosimilars for the U.S.
A biosimilar, as the name indicates, is similar to another biologic that has already been approved for use. In 2006, Sandoz received the first approval in the European Union for a biosimilar, Omnitrope®, a version of somatropin, or human growth hormone. The company subsequently received EU approval for a second biosimilar, Binocrit®, which is a version of epoetin alfa for regulating the formation of red blood cells. While Europe already has established a regulatory pathway for biosimilars, the U.S. remains engaged in discussions on draft guidance documents, definitions of study requirements, and intellectual property issues. Some industry analysts say that biosimilars can cost 20–25% less than the original product.