US Biosimilar Market Expands As BPCIA Turns 10

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market.  The BPCIA, signed into law on March 23, 2010, was slow to get going.  The FDA did not approve the first biosimilar product, Sandoz's Zarxio (Neupogen), until the spring of 2015, and Zarxio was first launched in September of that year.  In the past year, the U.S. biosimilar market has greatly expanded.  Sixteen biosimilar products are now marketed in the U.S.  Ten of the 16 were launched in 2019-20. 

Biosimilars of seven of the world's most important biologic medicines are now available:  Herceptin, Epogen, Neupogen, Remicade, Neulasta, Rituxan and Avastin.  These products include complex antibodies, such as Herceptin; simple recombinant proteins, such as Neupogen; and long-acting pegylated versions of recombinant proteins, such as Neulasta.  Except for Epogen, there are multiple biosimilar products for each innovator biologic medicine:  Herceptin (4), Neupogen (2), Remicade (2), Neulasta (3), Rituxan (2) and Avastin (2).

Biosimilars on US Market

Pfizer, an innovator company and a biosimilar maker, leads in the number of biosimilars on the U.S. market with six.  Most of the other biosimilar makers with marketed biosimilars, e.g., Amgen/Allergan, Sandoz, Mylan/Biocon and Teva, each have two biosimilars on the market. 

As the U.S. market matures and biosimilar makers have to compete with each other, we undoubtedly will see how the market develops and the impact on pricing of these medicines.  To date, most biosimilars have not been deeply discounted in comparison with each other or the innovator biologic medicine, although biosimilar makers reap enormous benefits from the U.S. biosimilar pathway.  Biosimilar makers obtain all the indications of an innovator biologic while avoiding costly and time-consuming clinical trials for each indication (trials that can last a decade in addition to the research and development in discovering the biologic in the first place).  Just this month, Teva and Celltrion launched the fourth biosimilar of Herceptin. It is being marketed at a 10% discount off the wholesale acquisition price (WAC) of the innovator product.