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Regulatory News | 29 March 2016 | By Zachary Brennan
With 56 new biosimilars in clinical development, IMS Consulting Group says in a new report that the biologic competitors could save health systems across Europe and the US as much as $110 billion through 2020.
But the savings for both regions will vary considerably as payers have adopted a variety of approaches to encourage physicians to prescribe biosimilars, motivate manufacturers and require certain clinical evidence to support the prescribing of these treatments.
For instance, Germany is among the most successful countries at educating physicians and implementing measures designed to stimulate biosimilar prescribing, IMS notes, whereas, in contrast, Austria’s approach to mandatory price reductions has resulted in reduced access to some biosimilars.
IMS is predicting that the total savings from biosimilars could be anywhere from $56 billion to $110 billion over the next five years, depending on how large the price reductions are and how quickly the competition increases for eight major biologic medicines that are expected to lose exclusivity protection.
The IMS report is based on independent research and analysis undertaken by the IMS Consulting Group and funded by Novartis.
The combined value in 2015 of these eight top-selling biologics losing exclusivity protection from patents or other measures between 2015 and 2020 in France, Germany, Italy, Spain and the UK, as well as the US, was €42.3 billion.
IMS also found that 30 companies are actively developing biosimilars of 16 distinct molecules that will lead to greater competition by 2020, particularly for infliximab, etanercept, rituximab and adalimumab.
“Substantial untapped potential from biosimilars exists across the EU reflecting different policy and implementation approaches,” the report says.
The report, which focuses mostly on the more-developed EU market for biosimilars (in the US, FDA is currently reviewing seven biosimilar applications), notes that the marketing of these cost-saving biosimilars will be a game-changer for two major therapy areas: Inflammation and diabetes.
Among those is one of the world’s biggest-selling drugs of all-time, AbbVie’s Humira (adalimumab), which had sales of €10.8 billion in five EU countries and the US, and loses exclusivity in both regions in 2018. Similarly, Amgen and Pfizer’s Enbrel (etanercept), which is used in the treatment of a number of chronic inflammation conditions earned €6.9 billion across in the EU and US and is expected to lose exclusivity in 2016 in the EU and in 2029 in the US.
Sanofi-Aventis’ diabetes drug Lantus (insulin glargine), which had sales of €8.7 billion in the EU and US last year lost exclusivity in the EU in 2015.
In addition to savings, the report notes that patients are increasingly accessing new treatments when biosimilars become available.
In markets where access to these molecules was previously restricted, including Romania, Bulgaria, and the Czech Republic, average uptake of erythropoietins increased by more than 250% following the introduction of biosimilars.
On the flip side, the main reason biosimilars are not being prescribed in some regions is that “many physicians continue to express concern over the efficacy and safety of these agents,” IMS says.
In October 2015, PharmaPhorum surveyed doctors in France, Spain and the UK and found that the majority of manufacturers emphasize the central role of physician choice, and argue against giving pharmacists the right to override physician prescriptions.
Likewise in the US, a number of states have passed legislation that requires a biosimilar to be deemed by FDA to be interchangeable before a pharmacist can automatically substitute a biosimilar for a biologic. No interchangeable biosimilars have been approved in the US yet.
Tags: IMS Health, biosimilar uptake, biosimilar savings