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Improving understanding of biotherapeutics and biosimilars Biosimilars/General | Posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

Mexico trade deal impacts biologicals exclusivity Policies & Legislation | Posted 21/09/2018

The US announced a new ‘understanding’ on trade with Mexico on 27 August 2018.  The announcement comes as part of efforts to re-negotiate the North American Free Trade Agreement (NAFTA) betwee...

Selection of quality attributes and test methods in biosimilarity assessment Biosimilars/Research | Posted 21/09/2018

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to autho...

Factors influencing the use of trade and generic names Generics/Research | Posted 21/09/2018

Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the u...

Adalimumab and trastuzumab biosimilars gain EC approval Biosimilars/News | Posted 21/09/2018

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).

FDA releases product-specific guidance to increase generics competition Guidelines | Posted 21/09/2018

The US Food and Drug Administration (FDA) has issued 54 product-specific draft guidances with the aim of promoting access to generics and increasing drug price competition.

Increase in use of biosimilar rituximab for NHL treatment Biosimilars/Research | Posted 21/09/2018

Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed since the first biosimilars of rituximab were approved in the European Unio...

Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon Generics/General | Posted 21/09/2018

Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo and will also part ways with eye care specialist Alcon.