A Minimalist Design Looks Great for Clearing Tau
Interception of Extracellular Tau by Antibodies May Be Sufficient to Stop the Spread of Tau in AD
Spherical Nucleic Acids Deliver a New Package for Oliognucleotide Therapeutics
SNAs Are a Hopeful First Step in Boosting the Utility of Oligonucleotides to Treat a Variety of Human Diseases
Downstream Issues Still Beset Production
To Protect the Bottom Line, Biomanufacturers Invest in Downstream Purification Technology
GEN Roundup: No Detail Is Too Small in Bioprocess Scaleup
A Change in Scale Can Change Everything
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 While Europe already has established a regulatory pathway for biosimilars, the U.S. remains engaged in discussions on draft guidance documents, definitions of study requirements, and intellectual property issues.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.