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News

FDA approves bevacizumab biosimilar Zirabev posted 19/07/2019

US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration...

FDA approves trastuzumab biosimilar Kanjinti posted 08/07/2019

US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the U...

Alteogen gains approval to start aflibercept biosimilar trial in Korea posted 08/07/2019

South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Fo...

Trastuzumab biosimilar from Prestige accepted for review by EMA posted 19/06/2019

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastu...

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb) posted 19/06/2019

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacio...

 

Research

Positive phase III results for trastuzumab follow-on biological Zedora posted 19/07/2019

Results of a post-marketing study of Biocon and Mylan’s trastuzumab biosimilar Zedora (MYL-1401O) compared to Herceptin (tras...

Real-world data confirms safety of infliximab biosimilar CT-P13 posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumato...

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden posted 08/07/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subseq...

Positive phase I results for Bio-Thera’s bevacizumab copy biological posted 08/07/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1...

Is switching to biosimilar infliximab safe? posted 14/06/2019

Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switchin...

 

General

Asian specialists recommendations for off-patent biologicals in IBD posted 19/07/2019

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biolo...

UnitedHealthcare to prefer brand-name pegfilgrastim posted 11/07/2019

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

Eli Lilly launches lower-priced insulin lispro posted 08/07/2019

Eli Lilly announced on 22 May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatm...

Recommendations for similar biotherapeutic products published by Latin American MS experts posted 08/07/2019

Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of exp...

Switching V19A17 Irish hospitals to get incentives to switch patients to biosimilars posted 07/06/2019

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