It hasn’t been suggested that Terumo is upgrading its pre-filled injectable syringe capacity simply because of POH.
The most immediate reason for the upgrade, which was referred to by Terumo in its press release, is that European marketing approval is expected soon for a Humira biosimilar (a biosimilar is basically a biologic generic drug). In a collective effort, Fujifilm Kyowa Kirin Biologics has developed the Humira biosimilar, Terumo has been tasked with combining the drug with its proprietary polymer PLAJEX prefillable syringe and Mylan (yes, Mylan) will be responsible for marketing the drug in Europe. If approved, the product will compete against several other Humira biosimilars and will also represent the first PLAJEX prefilled drug to be marketed outside of Japan.
Terumo is hoping that this Humira biosimilar is just the first of many PLAJEX prefilled drugs to make it to market. In Terumo’s 2017 Annual Report, the President of its General Hospital Company states that as part of the Company’s mid- to long-term growth strategy
We will work with pharmaceutical companies to provide new value and expand our BtoB business inside and outside Japan. We will focus on developing prefilled syringe and prefillable syringe products that are suitable for biomedical and pharmaceutical products, and on our contract manufacturing business that utilizes advanced sterilized manufacturing technology. We will also expand our packaged business in which we sell injection needles and intravenous needles packaged with drugs provided by pharmaceutical companies.
It was also noted that
It is….becoming difficult for pharmaceutical companies to engage in new blockbuster drug development, placing them in a very harsh business environment. Amid these changes, demand is increasing from pharmaceutical companies for drug administration devices that can differentiate their drugs…
In summary, Terumo needs to expand its prefilled syringe capacity in the short term to fulfil its requirements as CMO for Fujifilm Kyowa Kirin’s Humira biosimilar. Beyond that, Terumo also has plans to further develop its packaged business – i.e. drug and device (D & D) products. Part of its planned growth in this area will come through acting as a CMO for other pharmas’ new and generic drugs. Another part of its growth will need to come from higher value-added D & D products in which Terumo combines its own injectable device with its own (differentiated) drug products.
This is where POH and TPM can help out.
https://www.terumo-europe.com/en-em...application-for-a-biosimilar-to-be-formulated
https://www.biopharma-reporter.com/...ialise-Fujifilm-s-Humira-biosimilar-in-Europe
http://www.terumo.com/archive/ar_e/2017/AR_2017_E_02.pdf
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