TOWARD A NEW BUSINESS MODEL FOR BIOSIMILARS

Author(s)

Rémuzat C1, Kornfeld M1, Caban A2, Toumi M3
1Creativ-Ceutical, Paris, France, 2Creativ-Ceutical, Cracow, Poland, 3Faculté de Médecine Laboratoire de Santé Publique, Aix-Marseille Université, Université de la Méditerranée, Marseille Cedex, France, Marseille, France

Background: Biosimilars are expected to contribute to substantial savings estimated at around €50-100 billion cumulative savings in the five coming years in the European Union (EU) and the United States. Beyond impacting the drug budget, biosimilars will also expand access to biological products; these benefits are referred as societal value of biosimilars. However, full potential benefit of biosimilars will only be realized if they are massively adopted. Such success requires a new business model of pharmaceutical industry. This research aims to set grounds for such model named multi-stakeholders biosimilar business model. Discussion: Establishing conditions for adoption of biosimilars require understanding of the rules that will govern this market. Patients and physicians are critical decision makers, while switching /substitution are generally not enforced contrary to generic medicines, and decisions have to be made on individual basis by physicians and with patient consent. Payers expect to capture the potential savings associated to biosimilar adoption. Large industry players are widely engaged in the biosimilar business even though often through independent legal entities. Competition is a major feature of biosimilar market to deliver their full potential benefit. Each stakeholder may act as a bottle neck and prevent adoption of biosimilars. Only a multi-stakeholder win-win strategy will allow capturing the societal value of biosimilars and the business model should engage simultaneously all stakeholders to be successful. Educational programs should be put in place to better inform prescribers, pharmacists and patients and this should be supported by regulatory agencies, payers and public health authorities. Manufacturers need to develop synergies with payers and regulators to help capturing societal value of biosimilars while ensuring sustainability of this industry. Payers should develop incentives to support uptake of biosimilars. Conclusion: A multi-stakeholder business model seems the only way forward to capture the full societal value of biosimilars.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP381

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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