Darren Mansell, regulatory affairs manager at Owen Mumford looks at the EU and US regulatory differences when it comes to drug delivery devices.
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In Europe, a fifth of total spend on biologics (€12 billion) is already exposed to competition from biosimilars.[1] Meanwhile, in the US, just under a fifth of the biologics market (worth $211 billion dollars) is exposed to biosimilar competition, and three fifths of the market has the potential for biosimilar development.[2] Manufacturers of originator biologics are taking various measures to defend against this competition, such as reformulating drugs, making dosing improvements, or changing drug delivery devices. Similarly, biosimilar manufacturers must differentiate from other producers, to be able to secure sufficient market share.
DEVICE INNOVATION