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Business & Regulation Biosimilars

Bluff or Serious Biosimilar Bet?

| Eva McLellan and Martyn Smith

The players and chips are ready, what can poker teach us about the biosimilars business?

Business & Regulation Biosimilars

Biosimilar Champion

| Carol Lynch

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

Business & Regulation Biosimilars

Negotiating GDUFA II

| James Strachan

Are reduced GDUFA fees on the horizon for contract manufacturers?

Manufacture Biosimilars

The optimization and scale-up of high shear granulation

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.

Business & Regulation Business Practice

Surveying the Biologic Patent Battleground

| Laura von Hertzen

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

Manufacture Analytical Science

The Science of Sugar: Lessons Learned with Pauline Rudd

| Pauline Rudd

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

Business & Regulation Biosimilars

Walking the Biosimilar Guideline

| James Strachan

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

Discovery & Development Biosimilars

Accelerating the development of generic pharmaceuticals

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.

Manufacture Facilities

Nominations for The Power List 2017

| Stephanie Sutton

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

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.

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