May 23, 2017
TOKYO, JAPAN - May 23, 2017 - Terumo Corporation (TSE: 4543) announced today that European Medicines Agency (EMA) has validated on May 18 for review the Marketing Authorization Application for a biosimilar to be formulated by Terumo. With this validation, the application is complete and the EMA will now begin the review procedure.
The primary container of the biosimilar is PLAJEX™, Terumo's polymer prefillable syringe. It is the first time that medicines filled in PLAJEX™ have been applied outside Japan.
Based on this achievement, Terumo will continue to expand its alliance business with pharmaceutical companies by taking advantage of material technology and aseptic filling technology of prefillable syringes.
PLAJEX™ is a sterile ready-to-fill polymer syringe developed by Terumo with a strong focus towards biopharmaceuticals. Key features of PLAJEX™ include:
The biosimilar is FKB327, an adalimumab biosimilar candidate of the fully human anti-TNF-α monoclonal antibody referencing Humira®. In October, 2016, FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. announced positive result in primary endpoint from Phase 3 global clinical study of FKB327.
Terumo has developed the biosimilar as a combination product that combines drug and device, collaborating with Fujifilm Kyowa Kirin Biologics and others. They adopted Terumo as a contract manufacturing organization.
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. was established by FUJIFILM Corporation and Kyowa Hakko Kirin Co., Ltd. on March 27, 2012 as a company for developing, manufacturing, and marketing biosimilars.
Silicone oil has been used as lubrication to achieve smooth plunger gliding functionality. However, in the context of biomolecules, silicone oil became a serious issue because it can induce protein aggregation. Terumo has developed a silicone oil-free prefillable polymer syringe system based on a plunger stopper combined with a specific coating technology, called i-coating™ providing smooth surface layer and consistent gliding forces over time.
Earlier publications indicated that protein oxidation was induced in polymer prefillable syringes generated radicals by irradiation sterilization. On the other hand, no remarkable protein oxidation or radical generation was observed in steam-sterilized polymer prefillable syringe. Using steam sterilization as the sterilization method of PLAJEX™ may assist in mitigating interactions with the biopharmaceuticals by reducing the risks of protein oxidation.
(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.