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Stada to in-license adalimumab biosimilar Posted 05/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an adalimumab biosimilar.

In their ‘letter of intent’ Stada and mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, stipulate that the two companies will reach a decision within six months.

The news follows Stada’s in-licensing of a teriparatide biosimilar from Richter-Helm BioTec [1] and fits with the firm’s strategy of in-licensing of ‘selected biosimilars’. In this way, Stada intends to ‘continuously expand its portfolio of quality products at comparably favourable conditions’.

Adalimumab is a human monoclonal antibody that treats autoimmune diseases. It is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.

AbbVie’s blockbuster originator product, Humira, is the world’s top-selling prescription drug with 2013 sales of approximately US$10.7 billion, accounting for almost 60% of AbbVie’s total sales. Patents on Humira expire in the US in December 2016 and in Europe April 2018 [1].

Stada already markets a biosimilar in Europe, Silapo (epoetin zeta) [2], and has also in-licensed a biosimilar filgrastim product (Grastofil) from Canada-based Apotex [3]. Stada also made a deal with Hungary-based Gedeon Richter (Richter) in 2011 for biosimilars of two monoclonal antibody products, rituximab and trastuzumab, which are used to treat cancer and autoimmune diseases [4].

No adalimumab biosimilars are yet marketed in Europe [2].

Related article
Biosimilars of adalimumab

References
1.   GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020 
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3.   GaBI Online - Generics and Biosimilars Initiative. Stada in-licenses biosimilar filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/News/Stada-in-licenses-biosimilar-filgrastim 
4.   GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Biosimilars/News/Stada-and-Richter-to-collaborate-on-biosimilar-development 

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Source: Stada

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