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Phase I study suggests similarity of omalizumab biosimilar Biosimilars/Research | Posted 16/11/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenici...

DIA Global Annual Meeting 2019 Conferences | Posted 16/11/2018

DIA Global Annual Meeting 2019 23-27 June 2019 San Diego, CA, USA

Ensuring a stable supply of APIs in Japan Generics/Research | Posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indispensable for promoting the use of generi...

FDA approves adalimumab and pegfilgrastim biosimilars Biosimilars/News | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.

Inflectra may not be less expensive than Remicade in US Biosimilars/Research | Posted 09/11/2018

According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moderately less expensive than the originator biological Remicade (infliximab...

FDA issues guidance for developers of complex generics Guidelines | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 9 October 2018 that it had released new guidance documents as part of its efforts to advance the development of generics of complex drugs with...

Phase III study of biosimilar pegfilgrastim confirms safety and effectiveness in patients on myelosuppressive chemotherapy Biosimilars/Research | Posted 09/11/2018

Canada-based Apobiologix, a division of Apotex, reported results of an international, phase III, randomized, double-blind clinical trial to demonstrate biosimilarity between the Apotex pegfilgrasti...

Teva sues FDA for changing ‘first applicant’ definition for generics Generics/General | Posted 09/11/2018

There is yet another twist in the tale of generics of Allergan’s blockbuster dry eye treatment, Restasis (cyclosporine ophthalmic emulsion). The latest development has Israeli generics giant Teva P...