Seven out of the top ten drugs are biologics. All will lose patent protection by 2020, representing an underlying pool of $60 billion in branded sales to grab for biosimilars. Are biosimilars the new El Dorado of the pharma industry? If only it was that simple to strike gold! The biosimilars market is a challenging business, where players have to deal with high R&D costs, unclear regulatory pathways, and uncertainty around business models.
First, let’s review the key characteristics of the biosimilars game. To play, large investments are required; companies need to invest $150-300 million over an eight-year time frame just to come up with a valid biosimilar compound. Next, a further $50-100 million is needed to set up reliable manufacturing capacity – unless the player can leverage existing biologic manufacturing capacity.