A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are versions of original “innovator” products and can be manufactured when the original product’s patent expires. Reference to the innovator product is an important element of their regulatory approval.
According to McKinsey & Company, “manufacturers will continue to increase focus in fast-growing Europe, while the US keeps progressing slower with the promise of enormous potential.”
Challenges in Biosimilar Development
Biosimilar uptake in the U.S. has remained low due to what McKinsey states are a range of challenges such as contracting provisions such as those related to rebates that inhibit new entrants, limited differences in patient co-payments, no established incentive mechanism for physicians, and a reluctance to change existing medications within chronic specialties such as Multiple Sclerosis.
FDA commissioner Dr. Scott Gottlieb comments at the National Health Conference characterized biosimilar development programs as follows “…the economics of development are currently unstable; and the pipeline of biosimilar products that we hope for could be dramatically affected by the weakening of market incentives to bring these products to patients.”
Increasing Momentum for Biosimilar Development
In early 2017, the FDA released its first draft guidance regarding the interchangeability of biosimilars, and indicated in April that there will be forthcoming revisions that will likely reduce the size of the studies needed to demonstrate biosimilarity.
Some analysts project the growth of the biosimilars market at approximately 50% per year, which would have it reaching $100 billion by 2025.
Read more: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/five-things-to-know-about-biosimilars-right-now