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FDA to refer citizen petitions attempting to delay generics to FTC Guidelines | Posted 26/10/2018

The US Food and Drug Administration (FDA) announced on 2 October 2018 that it had released new draft guidance designed to limit the use of citizen petitions to delay approval of generics and biosim...

Originator biologicals and biosimilars under attack in UK and Japan Biosimilars/General | Posted 26/10/2018

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Mass spectrometry comparison of Remicade and Remsima Biosimilars/Research | Posted 26/10/2018

The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim biosimilar Zarxio (filgrastim-sndz) [1]. Since then, FDA has approved 11...

Momenta to reduce its biosimilars programmes Pharma News | Posted 26/10/2018

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 October 2018 that it would be focusing on two key biosimilars and quit the development of five others.

Switching to etanercept biosimilar SB4 safe and effective in a hospital setting Biosimilars/Research | Posted 26/10/2018

Authors of a study carried out at a UK hospital found switching to etanercept biosimilar SB4 to be safe and effective [1].

FDA reviews adalimumab biosimilar SB5 Biosimilars/News | Posted 26/10/2018

Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).

China approves first ambrisentan generic Generics/News | Posted 26/10/2018

China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its first ambrisentan generic.

Expediting FDA approvals for biosimilars Biosimilars/Research | Posted 19/10/2018

A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review [1]. Recom...