Baxter and Coherus amend biosimilar etanercept collaboration

Biosimilars/News | Posted 29/05/2015 post-comment0 Post your comment

US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 that they had amended some of the financial terms of their collaboration agreement for CHS-0214, an etanercept biosimilar candidate.

Shaking hands V13D29

The two companies made an exclusive collaboration agreement in September 2013 to develop and commercialize an etanercept biosimilar for Brazil, Canada, Europe and certain other markets [1].

Under the terms of the amended agreement, certain existing milestones and funding obligations have been revised, and the collaboration has been expanded to include select pre-commercialization activities. In total, the revised milestone payments may exceed the previous Baxter funding obligations by approximately US$12 million. Baxter has also agreed to purchase Coherus common stock in a private placement transaction.

‘With this amended agreement, we will continue to advance development of the etanercept biosimilar program[me] and begin preparations for eventual commercialization in Europe,’ said Dagmar Rosa-Björkeson, global head of biosimilars for Baxter BioScience.

Coherus announced in October 2013 that its etanercept biosimilar (CHS-0214) had met the primary endpoint of clinical pharmacokinetic similarity to the originator biological Enbrel (etanercept) in a confirmatory clinical study in healthy subjects [2]. This was followed by the start of a global phase III trial to evaluate the efficacy and safety of CHS-0214 compared to Amgen’s blockbuster arthritis treatment Enbrel (etanercept) in subjects with rheumatoid arthritis. Coherus is also planning another phase III trial with its biosimilar etanercept candidate (CHS-0214) in patients with chronic plaque psoriasis, according to ClinicalTrials.gov [3].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. Baxter and Coherus to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/News/Baxter-and-Coherus-to-collaborate-on-biosimilars 
2.   GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilar has comparable pharmacokinetics to Enbrel [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/Research/Etanercept-biosimilar-has-comparable-pharmacokinetics-to-Enbrel 
3.   GaBI Online - Generics and Biosimilars Initiative. Coherus starts phase III biosimilar etanercept trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 29]. Available from: www.gabionline.net/Biosimilars/News/Coherus-starts-phase-III-biosimilar-etanercept-trial 

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Source: Coherus

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