Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).
Etanercept biosimilar submitted for approval in Japan
Biosimilars/News
|
Posted 17/02/2017
0
Post your comment
Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
Mochida’s product is a proposed biosimilar of Amgen/Pfizer’s Enbrel (etanercept), which had worldwide sales of US$8.7 billion in 2015. The patents on Enbrel will expire in the US in November 2028, after Amgen was granted a new patent; and expired in Europe in August 2015 [1, 2].
Mochida has in-licensed LBEC0101 from LG Life Sciences (which has recently merged with LG Chem) for the Japanese market. According to ClinicalTrials.gov, LG Life Sciences has two ongoing phase III studies for LBEC0101 in rheumatoid arthritis patients.
Mochida has also in-licensed an adalimumab biosimilar (LBAL) from LG Life Sciences and a teriparatide biosimilar (RGB-10) from Gideon Richter.
Related article
Biosimilars of etanercept
References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.
Source: Mochida
Research
HHS push to ‘genericize’ biosimilars sparks backlash
Biosimilar interchangeability: a necessary fix, but not a silver bullet
General
Medicines for Europe calls for Biotech Act reforms to address ‘biosimilar void’
SBR issues position statement on safe originator biological/biosimilar interchangeability
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
EMA recommends approval for biosimilar pegfilgrastim Cavoley
FDA approves first interchangeable ranibizumab biosimilar Ranluspec
Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
Biosimilars/News Posted 15/09/2026
FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
Biosimilars/News Posted 02/09/2026
FDA approves first interchangeable ranibizumab biosimilar Ranluspec
Biosimilars/News Posted 04/08/2026
The best selling biotechnology drugs of 2008: the next biosimilars targets
Post your comment