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Biosimilars

ST002293

Japanese approval for first adalimumab biosimilar

Biosimilars/News | Posted 03/07/2020

Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

mAb Abzymes V18D06

Biosimilars in Belgium: increasing competition

Biosimilars/Research | Posted 03/07/2020

Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.

Immunology Serology V18D06

Positive phase I results for Innovent’s ipilimumab copy biological

Biosimilars/Research | Posted 03/07/2020

China-based Innovent Biologics (Innovent) announced on 3 June 2020 positive phase I results for its candidate ipilimumab copy biological, IBI310.

Rheumatology.org V13H09

EC approval for etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/07/2020

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin.

Bevacizumab protein structure V16K25

China approves bevacizumab copy biological Byvasda

Biosimilars/News | Posted 26/06/2020

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

Patient MD002316 V13C05

Successfully transitioning patients with IBD to biosimilars

Biosimilars/Research | Posted 26/06/2020

Pharmacists and physicians from the Boston Medical Center describe the successful transition of patients with inflammatory bowel disease (IBD) using the originator infliximab biological, Remicade, to the infliximab biosimilar, Inflectra (infliximab-dyyb) [1].

Pegfilgrastim V16B19

Canada approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 26/06/2020

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

X-ray2 MD001884

EULAR recommendations for DMARDs in rheumatoid arthritis

Biosimilars/Research | Posted 26/06/2020

The European League Against Rheumatism (EULAR) has updated its recommendations on the management of rheumatoid arthritis (RA) using synthetic and biological disease-modifying antirheumatic drugs (DMARDs) [1].

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Medscape hosts virtual symposium on biosimilars in IBD

Biosimilars/General | Posted 26/06/2020

Medscape held a virtual symposium on the use of biosimilars in inflammatory bowel disease (IBD) on 30 May 2020. The event covered issues including the regulatory approval process for biosimilars, research on biosimilars and switching.

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FDA approves insulin glargine biosimilar Semglee

Biosimilars/News | Posted 19/06/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its insulin glargine biosimilar Semglee (MYL‑1501D).