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FDA issues guidance on quality-related considerations for biosimilars Guidelines | Posted 31/05/2019

The US Food and Drug Administration (FDA) has issued draft biosimilar guidance on quality-related considerations.The draft guidance was published in a Federal Register announcement published on 22...

Factors contributing to long-term sustainability of biosimilars Reports | Posted 31/05/2019

The factors that may contribute to the long-term sustainability of the biosimilars market in Europe were presented by Murray Aitken of the IQVIA Institute for Human Data Science at the 17th Biosimi...

FDA’s Orange and Purple Books to be improved and updated Policies & Legislation | Posted 31/05/2019

On 8 May 2019, the US House of Representatives unanimously passed two bills that aim to enhance the utility of the US Food and Drug Administration’s (FDA) Orange Book for generics makers and the Pu...

NeuClone to start phase I trial for ustekinumab biosimilar Biosimilars/News | Posted 31/05/2019

Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.

Settlement for Udenyca and win for Zarxio Biosimilars/General | Posted 31/05/2019

Amgen has made a settlement with respect to pegfilgrastim biosimilar Udenyca, but has lost its appeal against filgrastim biosimilar Zarxio.

Positive results for rituximab copy biological IBI301 Biosimilars/Research | Posted 31/05/2019

US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI30...

Biocon/Mylan gain global rights to adalimumab biosimilar Hulio Biosimilars/General | Posted 31/05/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 7 May 2019 that they have gained the global rights to the adalimumab biosimilar Hulio.

Teva launches generic testosterone gel and overactive bladder treatment in the US Generics/News | Posted 31/05/2019

In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) t...