Biosimilars

Sitting Down With... Carol Lynch, Global Head Biopharmaceuticals, Sandoz.

Are reduced GDUFA fees on the horizon for contract manufacturers?

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

With an approaching patent cliff in biologics, are we be about to see a rise in litigation?

Pauline Rudd explains why sugars and glycosylation are important for biosimilars.

Not all successful biosimilar applications in Europe follow guidelines to the letter

In this article, triple detection SEC and MDRS are considered within the context of characterizing complex drug formulations, with specific case studies and results illustrating their application.

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

After finally breaking into the US market, biosimilars have created a real buzz in the industry, but the best practice for demonstrating similarity can be daunting to say the least.

Taylor Dispersion Analysis is an ultra-low volume, microcapillary flow technique for sizing and stability of biomolecules in complex solutions, and offers advantages for orthogonal and complementary biophysical characterization measurements.