Thompson Reuters published a good overview of the challenges facing companies developing biosimilars.
A few items which stood out for us were:
Europe Has Led, But… – While 17 biosimilars have been launched in Europe, the path has been slow and uncertain. Pricing for biosimilars remains high, and issues such as product naming and automatic substitution have not been fully resolved. In the US, individual states are getting involved via legislation, making it even more difficult for developers of biosimilars to gain a stronghold across the US.
Molecular Complexity as a Marketing Tool – Physicians never question the manufacturing process for generic oral small molecules, but they do for complex biopharmaceuticals. Thus, physicians may prefer brands simply because they trust that a major biopharmaceutical company will manufacture the biosimilar correctly. We imagine this would also favor established “branded” biomanufacturers such as Sandoz and Hospira. Smaller companies may struggle with this issue unless they force the issue through aggressive pricing.
Development Costs – According to the author, developing a biosimilar can dust up to $250 million over a 7-8 year period. There will not be many companies who can afford that level of investment and time commitment, and may partially explain why costs for biosimilars in Europe remain high.
Ultimately, it may be that the US biosimilars market will continue to evolve very slowly, while other markets (especially in Asia) will grow rapidly. Unless these issues are sorted out, we believe the biosimilars market in the US will continue to move forward very slowly, if at all.