Biosimilars
Trastuzumab biosimilar from Prestige accepted for review by EMA
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).
Eli Lilly launches lower-priced insulin lispro
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)
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).
UnitedHealthcare to prefer brand-name pegfilgrastim
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
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.
Biosimilars to replace older biologicals for IBD
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].
Trastuzumab biosimilar Ogivri approved in Canada
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.
Irish hospitals to get incentives to switch patients to biosimilars
Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.
Brazilian approval for trastuzumab follow-on biological Ontruzant
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.
Dramatic price reduction of trastuzumab in Malaysia
The price of the cancer drug trastuzumab has dropped by more than half in Malaysia following a recent tender to the Ministry of Health.
