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Biosimilars

Switching mAb Pfizer V18K30

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 originator and switching between biosimilars [1].

Trastuzumab Herceptin V13D12

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 Medicines Agency (EMA).

Insulin 1 V13C03

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.

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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-on biological, Herzuma (trastuzumab-pkrb).

Pegfilgrastim DrugBank V18K30

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.

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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, under the recently introduced Quality Consistency Evaluation (QCE) system.

IBD 1

Biosimilars to replace older biologicals for IBD

Biosimilars/Research | Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].

health budget cuts 2 V13l06

Trastuzumab biosimilar Ogivri approved in Canada

Biosimilars/News | Posted 07/06/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.

Switching V19A17

Irish hospitals to get incentives to switch patients to biosimilars

Biosimilars/General | Posted 07/06/2019

Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.

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Brazilian approval for trastuzumab follow-on biological Ontruzant

Biosimilars/News | Posted 07/06/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.