The Follow-on Biologics MarketEnter at your own risk |
|
Follow-on biologics (FOBs), also known as biosimilars, have gained tremendous attention in recent years as biologics continue to increase their market presence, focus on life-threatening diseases, and adopt high price tags. In 2010, biologics accounted for 28 percent of new molecular entities approved in the United States, and are expected to comprise up to 60 percent of the top-ten selling drugs by 2014.1 For over a decade now, Congress and the FDA have been contemplating a FOB regulatory pathway that would increase consumer access to affordable biologic therapies. With the passing of the Biologics Price Competition and Innovation Act (BPCI) as part of the 2010 Patient Protection and Affordable Care Act (PPACA), it seems that the wait is almost over.
While the exact nature of the pathway has not been revealed, there is a growing consensus among experienced industry observers that the market will look very different than that of current small molecule generics. It is not likely that we will see the same rate of FDA-approved entrants, brand market share erosion, or generic product price reduction. Instead, the market will grow slowly as physicians gain comfort with the clinical attributes and quality of biosimilars. Despite these roadblocks, we believe the FOB market will eventually emerge and flourish and competitors that lead the space will command multi-billion dollar businesses with a sustainable revenue stream. The key to success will be getting to market first with the correct molecules, and selecting the right strategies to help in that journey.
Download the PDF to read more about these strategies.
The follow-on biologics market: Enter at your own risk
(331.74 KB)
