Benoit Donze – Pricing and Market Access Consultant
The patents of two anti-TNF agents are due to expire over the next two years, in 2014 for J&J’s Remicade®, and in 2015 for Amgen’s Enbrel®. Their loss of exclusivity will clear the way for the arrival of biosimilar agents, defined as medicinal products which are similar to a biological medicinal product. The market access uptake of those biosimilars will be clearly facilitated by the economic crisis and by the payers’ willingness to reduce their healthcare expenditures. Thereby, biosimilars could represent one of the most important sources of savings over the next decade.
This article examines the possible pricing implications on the original drug and the anticipated price differentials between the original biologic and its associated biosimilar.
Study of pricing impact of biosimilars on their originator
The following analysis investigates the price differential between the price of biosimilars currently available on the market and their originator to predict prices of future biosimilars. This article does not take into consideration the complexity of anti-TNF biosimilars in term of clinical development, manufacturing and ‘similarity’ to branded anti-TNF which will for sure impact the price differential.
To date, three active substances have been approved for use in Europe by the Committee for Medicinal Products for Human Use (CHMP): filgrastim (a granulocyte colony-stimulating factor), epoetin (an erythropoietin stimulator) and somatropin (a human growth hormone). The table below shows the authorised biosimilars in the EU:
Currently, there are no mandatory price reductions imposed on the original biologic therapy after the entry of biosimilars. In the UK and Germany, there are no compulsory price reductions enforced on the biosimilar. In Spain, Italy and France, legislation states that biosimilars must be priced below the originator drug, 30% in Spain, at least 20% in Italy and at 15% in France.
What could we expect with anti-TNFs biosimilars?
Based on the analysis above, the anticipated price points of future anti-TNF biosimilars may be around 18% below the originator in France, 20% in Germany and Italy, 30% in Spain and 7% below the price of the original medicine in the UK.
We acknowledge that there are manufacturing issues (sophisticated technologies, processes, and high investments) associated with anti-TNFs biosimilars which translate to higher development costs than those required for current biosimilars. To date, Remsima® (first Remicade® monoclonal antibody to market), is only 5% less expensive than Remicade® in South Korea.
Moreover, the clinical efficacy and safety of these new biosimilar agents has not yet been confirmed. Pricing is one factor dictating market access: the lack of experience with anti-TNF biosimilars, safety and efficacy concerns (especially for biosimilars coming from Asia), and the reluctance to switch from physicians also play a significant role.
 MP advisors – Merck – Celltrion filed first mAB Biosimilar in Europe: Remicade Challenged – Consulted in January 2013
 Genetic Engineering & Biotechnology News – Firms Are Upping the Stakes on mAb Biosimilar Development – Consulted in January 2013
 EMA – Biosimilar medicines – consulted in January 2013