Pharmaceutical Technology - May 2019

Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 49 Benefiting the patient: Access to biosimilars European healthcare systems are based on soli- darity, which means that there is a collaborative effort to provide patients access to medicines at the lowest possible cost. Each year the Euro- pean Commission organizes an open forum for all stakeholders to report on the progress of this objective (20). An indirect but significant ben- efit of biosimilars is that post their introduction, typically the corresponding innovator company also offers considerable rebates to patients of sometimes 50% or more (21). For some smaller proteins such as short acting filgrastim, the cost has gone down by as much as 80%. It is critical to note that uptake of biosimilars in itself is a naïve parameter, as it overlooks where innovator products have been able to stay in the market at prices similar to those of biosimilars. As a result of the leadership exhibited by the EU, savings for healthcare systems and patients are now billions of Euros each year. S ome c ou nt r ie s , suc h a s D en m a rk , Nor- way, Poland, and Hungar y, have chosen for a centra lized top-down decision system to ten- der for biologics and implement the outcome as the only alternative (22). Across Europe in the more open healthcare systems such as UK, Germany, and The Netherlands, the following are four key factors that in close coherence ap- pear to be critical for acceptance by prescribers and patients of biosimilars as an alternative for the sometimes outrageous expensive reference products (23): • Multi-stakeholder approach: Get everyone in- volved, prescribing doctors, pharmacists, sup- porting staff and hospital management, and third-party payers. • One voice principle: The whole medical team should be educated to talk the same language to avoid the so-called nocebo-effect (a nega- tive not pharmacology-related negative thera- peutic outcome like side-effects or perceived loss of efficacy) (24). • Shared decision making: Involve the patient in the discussion when medication is being shifted toward a biosimilar, avoid ignorance and confusion (which may again induce a no- cebo-effect). • Gain sharing: Introduction of biosimilars takes time, transitioning patients from in- novator product to a biosimilar requires careful instruction, etc., and there should be some benefit for the local healthcare community. The EU—in collaboration with EMA—has pro- duced information materials to inform healthcare professionals and patients in many languages (25). In several countries, there are local initiatives to support hospitals to educate all stakeholders on the great value biosimilars can have for the access and sustainability of medical care. Summary While the EU and the US regulator y systems have so much in common, t hey are dif ferent in their approach toward mak ing biosimilars ava i lable to pat ient s . T he EU C om m ission lau nched init iat ives to t his end in t he ea rly 2000s, and as a result an abundance of avail- able biosimilars and impressive cost-savings for patients has been achieved. Patent litigation, politica l turmoil, and a prof it-driven hea lt h- care system have denied US patients access to the same benefits. Even FDA is appalled by the

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