Biosimilars: from Technical to Pharmacoeconomic Considerations

¹ Laboratoire Novartis Pharma, Rueil Malmaison, France
² Université Paris Descartes, Faculté de Pharmacie, France
³ Laboratoire Amgen, Neuilly-sur-Seine, France
⁴ Laboratoire Sandoz, Levallois Perret, France
⁵ Hospira France, Meudon la Forêt, France
⁶ Hôpital Lariboisière, AP-HP, Paris, France
⁷ Hôpital Saint Antoine, AP-HP, Paris, France
⁸ ANSM, Saint Denis, France
⁹ Laboratoire MSD, Courbevoie, France
¹⁰ CEPS, HEGP, Paris, France
¹¹ Marta Gersberg Conseil, Chatou, France
¹² LEEM, Paris, France
¹³ Hôpital Saint Louis, AP-HP, Paris, France
¹⁴ Hôpital Cochin, AP-HP, Paris, France
¹⁵ CHU, Faculté de Médecine, Toulouse, France
¹⁶ CNAMTS, Paris, France
¹⁷ Laboratoire Pfizer, Paris, France

Correspondence and offprints: Danièle Girault, Laboratoire Novartis Pharma, 2-4 rue Lionel Terray, BP 308, 92506 Rueil Malmaison, France. E-mail: daniele.girault@novartis.com

Received: 8 January 2015
Accepted: 12 January 2015

Abstract

A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.