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Comments on FDA’s public meeting on biosimilars Biosimilars/General | Posted 12/10/2018

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary...

Two darbepoetin alfa biosimilars submitted to Japan’s MHLW Biosimilars/News | Posted 12/10/2018

Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s regulatory agency, the Ministry for Health Labour a...

Reasons for switching to biosimilars and immunogenicity Biosimilars/Research | Posted 12/10/2018

Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].

Free prescriptions do not always increase use of generics Generics/Research | Posted 12/10/2018

One strategy to increase the use of generics is to offer them free-of-charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurer...

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.