Biosimilars
Recommendations for similar biotherapeutic products published by Latin American MS experts
Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay and Venezuela.
Alteogen gains approval to start aflibercept biosimilar trial in Korea
South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.
Positive phase I results for Bio-Thera’s bevacizumab copy biological
China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].
Is switching to biosimilar infliximab safe?
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 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].
