• Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA.
• FDA grants first interchangeable status for rapid acting insulin aspart, Kristy^TM.
• EMA sets record with 44 biosimilar authorizations in 2025.

Biosimilars continue to make 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.  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 161 applications have been approved in Europe.  Twenty of the authorizations have been withdrawn post-approval (Table 1).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, 89 other biosimilar drugs have gained U.S. approval to date including 25 interchangeable products (Table 2). 

As illustrated in the following graph, 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, and this imbalance was amplified in the past year.  In 2025 alone, the EMA authorized a record 44 biosimilars, far outpacing the 26 approvals granted by the FDA.  However, in October 2025, the FDA released updated guidance for biosimilars that aims to reduce unnecessary clinical testing and accelerate biosimilar development, so it’s possible the FDA may keep pace with EMA approvals in the future.

For biosimilar approvals, 2025 was the year of denosumab.  In the U.S., eight biosimilars were approved for both Prolia® (60 mg pre-filled syringe) and Xgeva® (120 mg vial).  In the EU, 12 biosimilars were approved for each product, making denosumab the antibody with the most biosimilars approved to date.  Additional highlights for the year 2025 include the FDA’s approval of Omylco® (omalizumab), the first biosimilar of Xolair®, which achieved interchangeability designation, and Kristy^TM, the first, and thus far only, rapid-acting insulin aspart biosimilar to achieve interchangeability status with the reference product NovoLog®.

Looking forward, there are currently only 14 biosimilar applications under review by the EMA for marketing authorization (Table 3).  However, as an increasing number of patents expire on biologic drugs, this number is expected to increase.  Additionally, the number of abbreviated biologics license applications at the FDA is expected to increase as the primary patents for some blockbuster drugs, such as Keytruda®, expire soon 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 January 16, 2026, and published on January 20, 2026).

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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