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Biosimilars

News

Advances for Formycon and Alteogen’s eye disease biosimilar candidates posted 16/04/2021

In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010)...

FDA accepts application for adalimumab biosimilar CHS-1420 posted 16/04/2021

US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accep...

Australian and Indian approval for teriparatide products posted 16/04/2021

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and th...

Argentina approves bevacizumab similar biological medicine Zutrab posted 16/04/2021

The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from A...

EC approval for insulin aspart biosimilar Kixelle posted 16/04/2021

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), devel...

 

Research

Characteristics associated with biosimilar use in Medicare recipients posted 16/04/2021

What patient, physician and practice characteristics are associated with biosimilar usage for the biologicals filgrastim and...

Biosimilars in the treatment of psoriasis posted 16/04/2021

A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the...

Adalimumab biosimilar FKB327 causes less pain than originator posted 12/04/2021

Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar FKB327 has been found to cause less injection-site pain compared to the...

Biosimilars regulation, clinical trials, approval and adverse events in Malaysia posted 12/04/2021

Compared to chemical drugs, biologicals are more expensive because of their complicated manufacturing processes. Patients oft...

Etanercept biosimilar injection pen, YLB113, convenient and easy to use posted 09/04/2021

A study of an injection pen formulation of the etanercept biosimilar YLB113, which is manufactured by the Japanese firm YL Bi...

 

General

Switching V19A17 British Columbia adds adalimumab to biosimilar switching programme posted 16/04/2021

British Columbia (BC), the first province in Canada to switch patients to biosimilar drugs, has added adalimumab to its switc...

Biosimilars of ustekinumab posted 12/04/2021

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response throug...

Biosimilars of aflibercept posted 09/04/2021

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet)...

Copy biologicals approved in China posted 09/04/2021

Last update: 2 April 2021In China, the regulatory body for the approval of medicines, including biologicals, is the National...

Biosimilars approved in South Korea posted 02/04/2021

Last update: 26 March 2021In South Korea, the regulatory body for the approval of medicines, including biologicals and b...