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Is switching to biosimilar infliximab safe? Biosimilars/Research | Posted 14/06/2019

Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switching to CT-P13 is safe, but more evidence is needed on switching back to or...

Trastuzumab biosimilar from Prestige accepted for review by EMA Biosimilars/News | Posted 14/06/2019

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medici...

Eli Lilly launches lower-priced insulin lispro Biosimilars/General | Posted 14/06/2019

Eli Lilly announced on 22 May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb) Biosimilars/News | Posted 14/06/2019

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow...

Comments on FDA’s plans to transition insulin products Guidelines | Posted 14/06/2019

The US Food and Drug Administration (FDA) held a public meeting on the 13 May 2019 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar...

UnitedHealthcare to prefer brand-name pegfilgrastim Biosimilars/General | Posted 14/06/2019

US health insurance provider UnitedHealthcare has announced that it will prefer use of brand-name pegfilgrastim over the biosimilar versions.

Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system Biosimilars/News | Posted 14/06/2019

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin...

Bulgaria and Cyprus added to EU-US mutual recognition agreement Policies & Legislation | Posted 14/06/2019

The European Medicines Agency (EMA) announced on 29 April 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU...