By Victoria Morgan, Director, Segment Marketing, Global Biologics
In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
There is a surge of interest in flexible fillers and packaging components that support this style of production. This technology lends itself well to small batch biologic production in multiple format presentations. If a pharma company can switch nimbly to a flexible filler, they can maximise production floorspace, have higher utilization rates on capital equipment and produce high quality, small batches.