Overview of FDA approved biosimilars


Michael Mühlegger

May 8, 2024

Table of contents


The number of FDA approved biosimilars has been constantly growing. While biologics are successfully used in the treatment of genetic and immune diseases like Crohn’s disease, psoriasis, arthritis and different cancers, the demand for less costly treatment options is increasing. Biosimilars, designed to equal reference biologics in quality and safety, are changing the market as an alternative that grants broader patient access through reduced costs.

In this article, we provide information about biosimilars and the difference between biosimilars and biologics. We will name key players in biosimilar manufacturing and introduce groundbreaking biosimilar products that have received FDA approval.1 

What are biosimilars?

Biosimilars are biological products that are created to be highly similar to already approved reference biologic drugs like vaccines, gene therapy or therapeutic proteins like monoclonal antibodies. Although they are not exact copies in terms of biological molecules, they are developed to have comparable quality, safety, and efficacy.

Just like biologics, the development of biosimilars underlies rigorous testing and has to comply with the regulatory framework set by healthcare authorities like the U.S. Food and Drug Administration. For biosimilars, this involves comparative testing against the reference product, including analytical characterization, preclinical studies, and clinical trials, to demonstrate no clinically meaningful differences. 

In many cases, biosimilars are less costly in comparison to brand name biological therapies, and health care professionals can prescribe them to patients as a cheaper alternative. The case of interchangeable biosimilars is an exception, as they can be substituted at the pharmacy without intervention of the health care provider because they meet additional requirements.2 

The differences between biologics and biosimilars

While both biologics and biosimilars are held to the same standards in terms of efficacy and safety, the pathway to biosimilar approval differs from the reference product. It can be said that it is more streamlined because it revolves around demonstrating similarity to the reference biologic.

This difference in development and production can lead to cost reductions in manufacturing biosimilars compared to biologics, which leads to a broader patient access as well as higher competition on the market for pharmaceuticals.3 

Who manufactures biosimilars?

The market for biosimilars is expanding. By 2028, revenue of $66.9 billion and an increase by 17,8% is expected. While there are several companies entering the market, the main players are established companies like Pfizer, Novartis, Amgen, Sandoz, and Biogen. The areas of application for their biosimilars have a strong focus on oncology and immune diseases like crohn’s disease or psoriasis.4 

List of FDA approved biosimilars

There are 49 biosimilars approved by the FDA as of April 2024. The list below shows them by their name, approval date, and reference product for each biosimilar. Further information can be found by clicking on the individual links.

Biosimilar NameApproval DateReference ProductMore Information
Selarsdi (ustekinumab-aekn)April 2024Stelara (ustekinumab)Selarsdi Information
Tyenne (tocilizumab-aazg) March 2024Actemra (tocilizumab)Tyenne Information
Jubbonti and Wyost (denosumab-bbdz)March 2024Prolia and Xgeva (denosumab)Jubbonti and Wyost Information
Simlandi (adalimumab-ryvk)February 2024Humira (adalimumab)Simlandi Information
Avzivi (bevacizumab-tnjn)December 2023Avastin (bevacizumab)Avzivi Information
Wezlana (ustekinumab-auub)October 2023Stelara (ustekinumab)Wezlana Information
Tofidence (tocilizumab-bavi)September 2023Actemra (tocilizumab)Tofidence Information
Tyruko (natalizumab-sztn)August 2023Tysabri (natalizumab)Tyruko Information
Yuflyma (adalimumab-aaty)May 2023Humira (adalimumab)Yuflyma Information
Idacio (adalimumab-aacf)December 2022Humira (adalimumab)Idacio Information
Vegzelma (bevacizumab-adcd)September 2022Avastin (bevacizumab)Vegelma Information
Stimufend (pegfilgrastim-fpgk)September 2022Neulasta (pegfilgrastim)Stimufend Information
Cimerli (ranibizumab-eqrn)August 2022Lucentis (ranibizumab) Cimerli Information
Fylnetra (pegfilgrastim-pbbk)May 2022Neulasta (pegfilgrastim)Fylnetra Information
Alymsys (bevacizumab-maly)April 2022Avastin (bevacizumab)Alymsys Information
Releuko (filgrastim-ayow)February 2022Neupogen (filgrastim) 
Yusimry (adalimumab-aqvh)December 2021Humira (adalimumab)


Yusimry Information


(insulin glargine-aglr)

December 2021Lantus (insulin glargine)Rezvoglar



September 2021 Lucentis (ranibizumab)

Byooviz Information 

Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions


(Insulin glargine-yfgn)

July 2021Lantus (Insulin glargine)

Semglee Information

Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes



December 2020Rituxan (rituximab)Riabni Information 



July 2020Humira (adalimumab)Hulio Information



June 2020Neulasta (pegfilgrastim)Nyvepria Information



December 2019Remicade (infliximab)Avsola Information



November 2019Humira (adalimumab)Abrilada Information



November 2019Neulasta (pegfilgrastim)Ziextenzo Information



July 2019Humira (adalimumab)Hadlima Information



July 2019Rituxan (rituximab)Ruxience Information



June 2019 Avastin (bevacizumab)Zirabev Information



June 2019 Herceptin (trastuzumab)Kanjinti Information 



April 2019Enbrel (etanercept)Eticovo Information



March 2019Herceptin (trastuzumab)Trazimera Information



January 2019Herceptin (trastuzumab)Ontruzant Information



December 2018 Herceptin (trastuzumab)Herzuma Information 



November 2018 Rituxan (rituximab)

Truxima Information

Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma



November 2018 Neulasta (pegfilgrastim)Udenyca Information 



October  2018Humira (adalimumab)Hyrimoz Information



July 2018Neupogen (filgrastim)Nivestym Information



June 2018Neluasta (pegfilgrastim)

Fulphila Information

Press Release: FDA approves first biosimilar to Neulasta to help reduce the risk   of infection during cancer treatment


(epoetin alfa-epbx)

May 2018Epogen (epoetin-alfa)

Retacrit information

Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia

Ixifi (infliximab-qbtx)December 2017 Remicade (infliximab)Ixifi information



December 2017 Herceptin (trastuzumab)

Ogivri information

Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers



September 2017Avastin (bevacizumab)

Mvasi information

Press Release: FDA approves first biosimilar for the treatment of cancer



August 2017Humira (adalimumab)Cyltezo information  
Renflexis (Infliximab-abda)May 2017Remicade (infliximab)Renflexis information


(Adalimumab -atto)

September 2016Humira (adalimumab)

Amjevita information

Press Release: FDA approves Amjevita



August 2016Enbrel (etanercept)

Erelzi information

Press Release: FDA approves Erelzi



April 2016  Remicade (infliximab)

Inflectra information

Press Release: FDA approves Inflectra



March 2015Neupogen (filgrastim)Zarxio information

Source: “Biosimilar Product Information”. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed April, 22 2024.

With new biosimilars being approved regularly by the FDA, an up-to-date version of this list can be found on the FDA’s website: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Overview of FDA approved biosimilars

Biosimilar products – review and approval process

The production of biosimilars involves living organisms in the form of cell cultures that are highly sensitive to changes in the production environment. To prevent variability within production badges and protect them from contamination, it is necessary to revert to reliable and innovative processing solutions and comply with good manufacturing practices (GMPs).

Manufacturers of biosimilars have to compose an array of different data from tests and trials that show the product's biosimilarity with the reference product. It starts with the characterization of the reference product and continues with animal studies and comparative clinical studies. Once the effectiveness and safety of the product are proven, the biosimilar may receive FDA approval.

While the trial is generally shorter for biosimilars than for their reference products, full documentation during production is needed to provide enough data for the FDA. Automated solutions based on single-use technologies help manufacturers to ensure safety and quality of the product by standardizing the production process. 5 

Meeting regulatory requirements with single-use technology

Pharmaceutical companies as well as CDMOs have to face several challenges in manufacturing biosimilars. This is also reflected in regulatory standards, fulfilling which is intricate in itself.

Single-use technologies offer enhanced safety, maintain drug substance quality, and boast high scalability and efficiency in the production of biosimilars, including processes like filling, freezing, and transportation.

By reducing contamination risks through human errors, innovations like Single Use Support's RoSS.FILL provides fully automated single-use filling platforms, facilitating standardization critical for cGMP compliance through sterile filling and filtration.

As it is often necessary to freeze drug substances in order to transport or store them, Single Use Support’s freeze and thaw platform RoSS.pFTU enables controlled and even plate-freezing and thawing at consistent rates to prevent protein alterations.

Preventing product loss is critical when it comes to the time and cost intensive production of biosimilars. Therefore, Single Use Support has developed RoSS® Shell, protective cases compatible with single-use bags that can be used during transport and storage, so biosimilar substances can reach their destination safe and sound. 

  1. The economics of biosimilars., Published 2013 Sep
  2. “Interchangeable biosimilar products”. Food and Drug Administration., https://www.fda.gov/media/151094/download, Published Accessed April, 20, 2024.
  3. Blackstone, Erwin A, and P Fuhr Joseph. “The economics of biosimilars.” American health & drug benefits vol. 6,8 (2013): 469-78., https://, Published
  4. “Biosimilar market”. Markets and Markets, https://www.marketsandmarkets.com/Market-Reports/biosimilars-40.html, Published Accessed April 21, 2024.
  5. “Biosimilar product: Regulatory Review and approval”. Food and Drug Administration., https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf, Published Accessed April 21, 2024.

Michael Mühlegger

Senior Director Marketing & Inside Sales

Michael Mühlegger is the Head of Marketing and Inside Sales at Single Use Support. He has 10+ years experience in the fields of marketing, inside sales, communications, content management, and creative production. With a keen understanding of market dynamics and customer behavior, Michael has successfully implemented innovative marketing strategies to drive business growth and enhance brand visibility.

He has a strong background in content management, with a focus on life sciences and biopharma trends, and is adept at creating compelling content across multiple platforms to engage audiences and effectively communicate brand messages.


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