François Bocquet(1)(2)(3), Pascal Paubel (1)(2)(3)
(1)Faculty of Pharmacy, Paris Descartes University, Sorbonne Paris Cite, Paris, France
(2)Health Law Institute, Inserm, UMR S 1145, Paris Descartes University, Sorbonne Paris Cite, Paris, France
(3)General Agency of Equipment and Health Products (AGEPS), Assistance Publique-H^opitaux de Paris (AP-HP), Paris, France
The global biologics market—which is forecast to be worth $250 billion in 2020 (i.e. 18% of the overall pharmaceutical market)1—is currently undergoing a profound upheaval following its opening-up to the biosimilars competition (copies of off-patent biologics)2. After losing a certain number of European and American patents related to biologics such as EPO (erythropoietins), G-CSF (Granulocyte-Colony
Stimulating Factors), and GH (Growth Hormones) over the past decade, patents related to leading and costly monoclonal antibodies (mAbs) are now disappearing—e.g. Remicade (infliximab), rituximab (Mabthera), bevacizumab (Avastin), etanercept (Enbrel), or adalimumab (Humira) used in oncology, for inflammatory, rheumatic, chronic, or skin diseases. This current situation now gives a new momentum to this market3. Healthcare payers are, thus, eagerly awaiting the arrival of such a competition in the
highly innovating mAbs sector in order to drive down drug prices and increase the patients’ access to these medicines. However, as for biosimilars already on the market, healthcare institutions and professionals must wonder whether or not the mAb biosimilar can be substituted for the mAb originator at the pharmacy level (when the mAb originator was prescribed). The stakeholders are currently wondering the following: does substituting biosimilars for the originators
(or vice versa) increase the safety risks—particularly the immunogenicity risk—or reduce efficacy at a higher proportion than what would be expected with repeated
administrations of the originators? Which medical and economic criteria should be taken into account to compare branded products and biosimilars with a view to a potential tender?
Article publié dans Journal of medical economics, 2016, VOL. 19, NO. 6, 645–647
http://dx.doi.org/10.1080/13696998.2016.1178649