Jonathan St-Germain: “Affordable? No. Biosimilars and affordability unfortunately do not go together. They cost to develop and they cost to manufacture. In general, their complexity means that more time, money and resources are required to produce them, to ensure their manufacturing quality and complete their assessment through bioanalytical studies. While there will always be a cost burden to biosimilars, however, it is inevitable that as time goes by, strategies must be developed to increase efficiency throughout the process of their development. The need for such therapeutics is such that they will keep on occupying a greater space in the drug industry and therefore, innovative strategies to make them more affordable will also be required.”
Paul Declerck: “The economic benefit of biosimilars is much less than with generics, as biosimilars can be 20-40% cheaper than the reference product, whereas generics can be up to 75% cheaper.”
Arno Kromminga: “Biosimilars are certainly more affordable. And with more routine manufacturing processes the costs may drop even more. However, costs pressure should not compromise safety. Clinical studies are still needed.”
Fernando de Mora: “Indeed, the development cost of a biosimilar is very high and not all companies can face it. In spite of such substantial investment, developing a biosimilar requires in general fewer resources than developing an originator product. This makes sense because biosimilar development is built upon the knowledge of the reference medicine (the original product to which it will claim equivalence) and therefore, the development plan can be customized. A clinical phase is needed, but not to the extent of the innovator compounds. Generally, this allows for less money to be required for biosimilar development and therefore, the product may be launched at a lower price than the originators already in the market. This brings competition into the marketplace and sometimes quite substantial discounts. Furthermore, a patient’s access to biological therapy increases and patients, therefore, have greatly benefited from the arrival of biosimilars.”
Mario DiPaola: “The complexity of biosimilars and the cost of developing a manufacturing process and demonstrating similarity does make biosimilar products quite expensive. Nevertheless, approved biosimilars are still 15% to 35%[1] lower in cost than the original products. These savings may seem modest, but they do have a positive effect on the overall costs of biopharmaceuticals. It is my expectation that as more biosimilars are approved, the competition will intensify, driving prices down further and expanding the affordability of these novel products.”
[1] Singh SC, Bagnato KM. The economic implications of biosimilars. Am. J. Manag. Care, 21(suppl 16), s331–s340 (2015).
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