Collaboration on cell lines for biosimilar characterization

2013-09-10 VelaLabs, a provider of analytical services to the global biologicals industry, and Evercyte, a producer of standardized, relevant cell systems, announced on 3 September 2013… Read More »

The global face of biosimilars

2013-06-15 Unlike traditional small molecule (chemical) drugs, the development of biologicals is different and variable with respect to the manufacturing process and environmental factors, such as… Read More »

Glossary of key terms

2013-01-24 Last update: 11 June 2013 Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognised as a problem… Read More »

Biosimilar terminology confusion

2013-01-23 Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA. The term biosimilar is the most… Read More »

Generic medicine switches confuse patients and reduce adherence

2013-01-17 Switching between generic medicines without explaining the reason to the patient can undermine trust in pharmacists, the Aston Medication Adherence Study (AMAS) has found. The… Read More »

EMA receives second application for biosimilar infliximab

2013-01-16 According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012,… Read More »

Overview of research on safety and immunogenicity of biosimilars in 2012

2013-01-15 Period: January to August 2012  Biosimilars or ‘biosimilar medicinal products’ are medicinal products that are similar (but not identical) in terms of quality, safety and… Read More »

EMA publishes revised biosimilar Q&A document for patients

2013-01-14 On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public. The revised… Read More »

EMA to accept biosimilar reference medicines from outside EEA

2013-01-11 EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved… Read More »

Boehringer Ingelheim starts biosimilar rituximab trial

2013-01-10 Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab. The biopharmaceutical specialist announced on 26 September… Read More »

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