The European Medicines Agency’s new, accelerated route to approval for innovative drugs seems to be especially attractive for biotech companies. But Health Technology Assessment institutions warn that the lack of substantial data might interfere with reimbursement.
The US has opened the floodgates to cheaper versions of biologic medicines, and analysts predict that by 2020, biosimilar protein meds could seize a significant share of a projected €390bn market. That’s good news for national health services and insurers, which stand to save billions in payouts. As expensive biologics begin to go off-patent, competitors with knockoffs are planning their onslaughts. But for biosimilars to have a future, both physicians and patients have to be sold on the idea – and many of them remain uninformed and unconvinced. The field is at a crucial juncture.
Amgen’s Imlygic was approved last year – a move that finally added oncolytic viruses (OVs) to the healthcare toolkit. Although the treatment’s scope of application as a stand-alone therapy is limited, many are viewing the event as Ground Zero for an explosive new age in medicine. Evidence is mounting that the full potential of virotherapies can only be realised in combination with other immunotherapies, chemotherapies or small-molecule therapies. A number of other European drug developers have now jumped on Amgen’s bandwagon.
Early January saw a few indicators that stock markets might deliver some solid biotech results in 2016, even if it wasn’t destined to be a hallmark year for the industry. But then, in the weeks that followed, the situation began to deteriorate. Now it looks like European biotech companies might have to start coming to terms with a closing IPO window.