Numerous Biosimilar Launches Coming Soon in United States

With more biosimilars on the market, their acceptability seems to be increasing.

In 2019, just 11 out of 26 biosimilars approved by the U.S. Food and Drug Administration have reached the market –– that is just 42%. The percentage is expected to rise rapidly in 2020, however.

Pfizer alone is expected to launch three biosimilar products by next February for Avastin (bevacizumab), Rituxan (rituximab), and Herceptin (trastuzumab). At least two other trastuzumab biosimilars are also expected to reach the market in early 2020. As a result, the percentage of FDA-approved biosimilars that have been launched should surpass 60%.

The growing number of biosimilars on the market appears to be having a positive effect on uptake, which was slow at first due to unfamiliarity and uncertainty regarding these “biogeneric” products that are similar but not the same as their branded counterparts.

Neulasta (pegfilgrastim) biosimilars from with Coherus (Udenyca (pegfilgrastim-cbqv)) and Mylan / Biocon (Fulphila (pegfilgrastim-jmdb)) have taken over 25% of the market in a little over one year, while Avastin biosimilar Mvasi (bevacizumab-awwb) from Amgen already as a 10% share after just four months on the market.

 Most of the biosimilars that have received approval in the United States but have not been launched are for Humira (adalimumab) and Enbrel (etanercept) due to patent issues. In Europe, on the other hand, biosimilars of these two products have captured 35% and 50% of their respective markets in approximately three years.

 The two biosimilars for Remicade (infliximab) launched in the United States account for just 12% of the market since their introduction over two years ago.

David Alvaro, Ph.D.

David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That's Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.