Germany’s drugmaker Merck KGaA (Merck Group) is to sell its biosimilars division, according to a statement made in its 2016 annual report.
Merck KGaA set up a dedicated biosimilars unit back in 2012, when it also made an agreement with India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) to co-develop biosimilar cancer drugs [1]. In 2014 Merck KGaA invested around Euros 100 million in biosimilars [2], followed by an additional US$130–150 million in biosimilars for 2015 [3]. The company has a phase III trial ongoing for its adalimumab biosimilar (MSB11022), which is expected to be completed in September 2017 [4].
However, to date the partnership has not yet submitted a biosimilar application in Europe or the US, while their rivals have been forging ahead. Amgen received US Food and Drug Administration (FDA) approval for its adalimumab biosimilar (Amjevita) in September 2016 [5] and European Union approval in March 2017 [6]. Boehringer Ingelheim submitted applications for approval of its adalimumab biosimilar to European Medicines Agency (EMA) and FDA in January 2017 [7].
Therefore, despite its investment in biosimilars, Merck KGaA states in its 2016 annual report that it ‘is in advanced stages of negotiations to divest the biosimilars business and the transaction is expected to close in 2017’. According to Reuters, Merck KGaA hired investment bank JP Morgan Chase & Co back in November 2016 ‘to sound out potential buyers for the biosimilar business’.
Merck KGaA may not be the only company considering leaving the biosimilars business. In an interview with Bloomberg, Allergan CEO, Brent Saunders, predicted many companies would eventually retreat from biosimilars. He added that Allergan ‘likely won’t do much with biosimilars beyond its current projects’. Allergan is currently developing four biosimilars in partnership with Amgen.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-and-Dr-Reddy-s-to-collaborate-on-biosimilar-mAbs
2. GaBI Online - Generics and Biosimilars Initiative. Merck KGaA to invest Euros 100 million in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-to-invest-Euros-100-million-in-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Merck KGaA plans further investment in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Merck-KGaA-plans-further-investment-in-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Merck Group starts phase III trial for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Merck-Group-starts-phase-III-trial-for-adalimumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
7. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
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Source: Bloomberg,Merck KGaA, Reuters
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