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Biosimilars

Discovery & Development Biosimilars

Finding Fingerprints of Biosimilars

| Fiona Greer

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.

Discovery & Development Biosimilars

Taylor Dispersion Analysis explained

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.

Manufacture Analytical Science

Piecing Together Protein Analysis

| Sponsored by ThermoFisher Scientific

When it comes to biosimilar development, companies must thoroughly characterize both the originator and the new candidate to demonstrate biosimilarity.

Business & Regulation Biosimilars

The Business of Biosimilars

| Charlotte Barker

Sitting Down With… Carsten Brockmeyer, CEO, Formycon, Germany.

Manufacture Biosimilars

Riddle Me This, Biosimilar

| Stephanie Sutton

The first US biosimilar – Zarxio from Sandoz – has been cleared for market. But the judges say it wasn’t an easy decision

Manufacture Biosimilars

Taylor Dispersion Analysis for assessing the self-association and stability of Insulin

Using Insulin as a case study, Taylor Dispersion measurements are used to monitor self-association and oligomeric state in a variety of buffer conditions, and have the ability to render surfactants and excipients invisible in measurement data.

Business & Regulation Biosimilars

Keeping a Finger on the Biosimilar Pulse

| Fiona Greer

The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic. Here, I discuss some of the many challenges – legal, regulatory, non-clinical and clinical – that manufacturers face when developing biosimilar products for global markets.

Manufacture Biosimilars

Biosimilars: the Big Picture

| Joshua Cohen

In the midst of wrangles over biosimilars naming and interchangeability, let’s not forget the key benefit – putting the brakes on the growth in biologics expenditure.

Manufacture Biosimilars

FDA Ups Generics Oversight

| Charlotte Barker

A US government study reports progress – but also highlights shortfalls

Manufacture Biosimilars

Biosimilar Buzz

| Stephanie Sutton

Regulators and manufacturers are readying for the opening of the US market, but legal wrangles continue to block the way

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