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Baxter and Coherus amend biosimilar etanercept collaboration Posted 29/05/2015

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.

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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