• FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
• After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more affordable treatment option without compromising on safety or efficacy. As biosimilars gain traction worldwide, regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) play a critical role in shaping their market introduction. While both agencies share similar goals of ensuring patient safety and promoting access to high-quality therapeutics, their regulatory pathways and approval trends show notable differences.

One such difference is that the EMA has historically been quicker than the FDA in approving biosimilars. Since 2005, the biosimilar regulatory framework in Europe has been implemented through the Committee for Medicinal Products for Human Use (CHMP) under the EMA. The CHMP provides initial assessments for marketing authorization of new medicines that are ultimately approved centrally by the EMA. Since Sandoz’s somatotropin biosimilar, Omnitrope®, was first authorized on April 12, 2006, an additional 124 applications have been approved in Europe. Sixteen of the authorizations have been withdrawn post-approval (Table 1). On average, the EMA takes about 1-2 years from submission of a biosimilar application to approval.

In contrast, the FDA’s biosimilar approval process has been relatively slow, with initial approval times averaging 3-4 years for the first generation of biosimilars. This delay in approval is partly due to the FDA’s more rigorous evaluation of biosimilars and the additional data required to achieve interchangeability designation. Additionally, the U.S. did not implement a regulatory framework for biosimilar evaluation until after enactment of the Biologics Price Competition and Innovation Act (BPCIA) of 2009. As the EMA had already approved over a dozen biosimilars by this time, Europe had a significant head start on both the number of approved biosimilars and the regulatory process for approving more. Sandoz’s filgrastim biosimilar, Zarxio®, received the first U.S. approval in 2015, whereas nine filgrastim biosimilars have been approved in Europe dating back to multiple authorizations in 2008. Despite the FDA’s relatively slower biosimilar approval pace, the U.S. biosimilar market has managed to grow continuously over the past decade. Subsequent to Zarxio®’s approval, 73 other biosimilar drugs have gained U.S. approval to date including 17 interchangeable products (Table 2).

As illustrated in the following graph, while the EU’s significant head start and higher approval rate led to an imbalance in the number of biosimilar drugs available in the respective markets, the FDA has increased the rate of approval in recent years. In 2024 alone, the FDA approved 19 biosimilars, the most approvals in a single year by either regulatory body to date.

In the first four months of 2025, Europe and the U.S. are nearly equivalent in the number of biosimilar approvals, having authorized 12 and 10 biosimilars, respectively. Of note, these approval numbers include both 60 mg pre-filled syringe (Connexance, Stoboclo, and Ospomyv/Obodence; referencing Prolia®) and 120 mg vial (Bomyntra, Osenvelt, and Xbryk; referencing Xgeva®) forms of denosumab. Should the high rate of approvals be maintained throughout the year, both the EMA and FDA are on track to surpass the record 19 approvals seen in 2024. Notably, the EMA has also issued favorable opinions for the approval of Jubereq and Osvyrti (denosumab) and Quyvolma (ustekinumab), though final marketing authorization is still pending. In the U.S., the FDA recently approved Omylco® (omalizumab), the first biosimilar of Xolair®, which also achieved interchangeability designation with the reference product.

Looking forward, there are currently 36 biosimilar applications under review by the EMA for marketing authorization (Table 3).  As an increasing number of patents expire on blockbuster biologic drugs, the number of abbreviated biologics license applications is also increasing. Biosimilars for more than 31 different original biologics are currently navigating biosimilar pathways or are in late stage development in the U.S. (Table 4).  

Table 1. European Medicines Agency List of Approved Biosimilar Drugs.

Table 2. U.S. Food and Drug Administration List of Approved Biosimilar Drugs.

Table 3. European Medicines Agency List of Biosimilars Under Evaluation for Marketing Approval (Source: EMA list of applications for new human medicines compiled on April 8, 2025, and published on April 16, 2025).

Table 4. Biologics having already expired or nearing primary patent expiry in the U.S. and biologics that have biosimilars in the regulatory pipeline. 

*Expiration dates are estimated and subject to change, for example, if pending patent term extension applications are granted.

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