Overview of FDA approved biosimilars

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 

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.