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Mundipharma buys Spanish biosimilars maker Cinfa Biotech Pharma News | Posted 12/10/2018

UK-based Mundipharma International (Mundipharma) is strengthening its position in biosimilars with the acquisition of Spanish biosimilars maker Cinfa Biotech.

European approval for fluticasone/salmeterol and gefitinib generics Generics/News | Posted 12/10/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic flu...

FDA approves first drug via Competitive Generic Therapy pathway Generics/General | Posted 12/10/2018

The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to sev...

EMA aims to improve the availability of medicines in Europe Policies & Legislation | Posted 12/10/2018

A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.

Stakeholder perspectives on biosimilars in oncology Biosimilars/Research | Posted 05/10/2018

Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regu...

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca Biosimilars/News | Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

Limited distribution networks found to be anticompetitive Generics/Research | Posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This lead...

Biosimilars no longer eligible for parallel processing in Australia Policies & Legislation | Posted 05/10/2018

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.