During the 35th Annual Health Care Conference held on 2−4 March 2015 in Boston, USA, US pharma giant Merck outlined its biosimilars programme.
Merck made a deal with Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis in 2013 [1]. As a result of this collaboration the companies now have five biosimilars programmes in phase III development, see Table 1, and they expect more biosimilars to follow.
| Reference product
|
Active substance
|
Reference product sales 2014 (billion $)*
|
Merck-Samsung Bioepis biosimilar
|
Expected filing
|
| Enbrel
|
etanercept
|
1.1
|
SB4
|
2015−2016**
|
| Herceptin
|
trastuzumab
|
6.9
|
SB3
|
2016
|
| Humira
|
adalimumab
|
8.0
|
SB5
|
2015−2016#
|
| Lantus
|
insulin glargine
|
8.4
|
MK-1293
|
2015−2016
|
| Remicade
|
infliximab
|
6.0
|
SB2
|
2015−2016#
|
*IMS Evaluate Pharma, February 2015; **excluding European Union, Japan and USA; #excluding European Union, Russia and Turkey.
Merck sees biosimilars as offering patients alternatives to existing biological therapies, as well as addressing the needs of healthcare systems to save money on existing treatment, thus creating cost capacity for new innovative treatments.
Merck made a deal with South Korea’s Hanwha Chemical Corporation (Hanwha) back in 2011 to develop and commercialize biosimilar etanercept (HD203). Under the terms of that previous agreement Merck is responsible for manufacturing and commercializing HD203 globally, except in Korea and Turkey where Hanwha has retained marketing rights [2]. The companies have recently signed an agreement to export the technology to make biosimilar etanercept to Merck. This news followed the approval of Hanwha’s biosimilar etanercept (HD203), which is called Davictrel, from the Korean Ministry of Food and Drug Safety (MFDS) on 11 November 2014 [3].
Merck has also made a biosimilars deal with contract research organization Parexel [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
2. GaBI Online - Generics and Biosimilars Initiative. Merck enters biosimilars deal with Korea's Hanwha [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Merck-enters-biosimilars-deal-with-Korea-s-Hanwha
3. GaBI Online - Generics and Biosimilars Initiative. Hanwha to transfer biosimilar etanercept technology to Merck [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Hanwha-to-transfer-biosimilar-etanercept-technology-to-Merck
4. GaBI Online - Generics and Biosimilars Initiative. Merck and Parexel form strategic alliance for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Parexel-form-strategic-alliance-for-biosimilars
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