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List of Companies with Approved Biosimilars

From 2015 – to 2020, the biosimilars industry has seen a makeshift change. The entire landscape of biosimilars has evolved during these years.

The innovator companies have been constantly trying to ensure multiple USFDA-approved biosimilars in their portfolios.

Out of all companies, Pfizer is particularly active In this regard with 9 approved biosimilars during this period. However, after COVID19 disease we can observe a shift to vaccine development, and hence in 2021 & 2022, we have not observed the USFDA-approved biosimilars.

In contrast to that in 2022, Amneal Pharmaceuticals, Inc has been a recent participant and has introduced two USFDA-approved biosimilars.


In 2021, Coherus BioSciences, Inc, Eli Lilly and Company, Mylan Pharmaceuticals Inc, and Samsung Bioepis & Biogen are the ones to receive USFDA-approved biosimilars.

All four companies are big-time investors in the biosimilars technology; however, Mylan seems to be better poised with 3 different USFA-approved biosimilars in its offerings.

  •  Mylan, Merk, and Pfizer are the three biosimilar products in the USA in 2020.
  • The year 2019 seems to be the most active in terms of USFDA-approved biosimilars.
  • The number is reaching to10 biosimilars out of 35 of the sample size, where Pfizer has got maximum approvals of 4 biosimilars.
  • The industry has seen various reference products during the time period of 2015-2020 and for these reference products, there are various available biosimilars.

The list includes the innovator, drug brand name, and drug substance including AbbVie-Humira (Adalimumab), Amgen-Enbrel (Etanercept), Genentech-Avastin (Bevacizumab), Biogen-Genentech-Rituxan (Rituximab), Genentech-Herceptin (Trastuzumab), Janssen Biotech-Remicade (Infliximab), Sanofi-Lantus (Insulin Glargine), Genentech-Herceptin (Trastuzumab), Novartis-Lucentis (Ranibizumab), Amgen-Neulasta (Pegfilgrastim), Amgen-Epogen (Epoetin-Alfa), Amgen-Neupogen (Filgrastim).

Humira is the highest-selling drug in 2020, followed by Eternacept, Bevacizumab, Rituxizumab, and Trastuzumab.

The Humira, from AbbVie, has crossed a whopping 20 billion dollars in sales which is far highest than any other drug in the world.

This is the reason for the same is leading in terms of the number of USFDA approved 7 biosimilars. Trastuzumab is followed by 5 approved biosimilars in the US and then the Bevacizumab which is having 4 approved biosimilars.

According to FDA, the reference is defined as the single biological product, approved by FDA, against which a proposed biosimilar product is compared while the biosimilar is defined as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product… Markets and surveys have launched new market reports targeting biosimilars.

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