GLP-1 Biosimilars: What You Need to Know About Copies, Patents, and International Regulation

When semaglutide started appearing everywhere, a question began circulating among patients and healthcare professionals: are the copies really equivalent to the original? The short answer is: it depends on how they were made, where they were approved, and who is looking. This article explains what GLP-1 biosimilars are, how they are evaluated in major markets, and what this means for the wallet of people who depend on these medications.

What Sets a Biosimilar Apart From a Conventional Drug

Traditional medications like aspirin are small molecules, easy to copy. The chemical structure is simple and can be reproduced with near-perfect precision in any laboratory. A biosimilar does not work that way. It is a copy of a biologic, which is a large, complex protein produced by living organisms. Small differences in the manufacturing process, such as temperature, pH, or cell line, can slightly alter the final product.

That is why biosimilar approval is not a simple bioequivalence analysis. It is necessary to demonstrate that the biosimilar is similar to the reference medication in terms of quality, biological activity, safety, and efficacy. This process takes years and costs hundreds of millions of dollars, yet it is still significantly cheaper than developing a new biologic from scratch.

The GLP-1 Patent Landscape

The original semaglutide (Ozempic) had its patent filed by Novo Nordisk and begins facing expiration in some markets starting in 2031. That does not mean copies will appear the next day. Patents are strategic and varied. Beyond the molecule itself, there are patents on the manufacturing method, the formulation, the injection device, and even on specific combinations with other substances.

Manufacturers like Eli Lilly, which develops tirzepatide, and other companies such as Gan & Lee, Huadong Medicine, and other Asian firms, are already positioning versions of semaglutide and liraglutide in markets where patents have expired or were not registered. In Brazil, for example, ANVISA has already approved biosimilars of insulin glargine and other biologics, paving the way for the same process with GLP-1 agonists.

How the FDA Evaluates Biosimilars in the United States

The American FDA created a specific regulatory pathway for biosimilars in 2009 through the Biosimilar Innovation Act. The process requires the demonstrative company to present extensive molecular characterization data, pharmacokinetic and pharmacodynamic studies, plus comparative clinical trials on safety and efficacy.

The FDA does not require the biosimilar to repeat all studies of the reference medication. Instead, it uses a stepwise comparison approach. If the molecular structure is sufficiently similar and the data reveal comparable profiles, approval may be granted with fewer studies than a new medication would require.

As of now, the FDA has not yet approved any semaglutide biosimilar, although several applications are under review. The expectation is that the first will reach the American market after 2031, when the main patents begin to expire.

EMA's Positioning in Europe

The European Medicines Agency operates with guidelines similar to the FDA's, but with some practical differences. EMA was a pioneer in biosimilar approval, having authorized the first in 2006. Its longer experience results in more predictable evaluation processes for companies.

In Europe, the reference medication and the biosimilar are evaluated independently, each following its own regulatory path. This means that a biosimilar approved in Europe underwent a separate analysis, not just a superficial comparison with the original.

EMA also offers the concept of interchangeability, which allows a pharmacist to substitute the reference medication with the biosimilar without physician intervention, provided the member country authorizes it. This flexibility may facilitate access, but it also raises concerns about traceability in case of adverse effects.

ANVISA and the Regulatory Landscape in Brazil

ANVISA followed the international regulatory model and established a specific board for biologics and biosimilars. Resolution RDC 55/2010 was the initial milestone, defining the requirements for approval of biocomparable products, as they are called in Brazil.

The ANVISA process requires comparability studies that assess quality, efficacy, and safety in full. Since no GLP-1 biosimilar has been approved in the country yet, companies that want to operate in this segment need to watch the regulatory landscape and the specific guidelines that should be published as demand grows.

For Brazilian patients, the arrival of biosimilars may represent a significant change in access. Medications like semaglutide still carry a high cost in the country, and competition from cheaper versions may push prices down, especially in the private system.

Impact on Prices: What to Expect

The economics of biosimilars are straightforward. When a reference medication loses market exclusivity, several manufacturers begin producing versions, supply increases, and prices drop. In the United States, insulin biosimilars, for example, came to cost up to 50% less than the original product after competitors entered the market.

For GLP-1 agonists, the impact has not yet materialized significantly because the main patents are still in force. But pharmaceutical sector experts estimate that competition may reduce prices by 30% to 60% when the first biosimilars effectively reach the global market.

There are, however, factors that complicate this forecast. Biological protein production is technical and expensive. Unlike tablets, which can be manufactured at scale easily, biosimilars require complex industrial infrastructure and specialized expertise. This means the number of manufacturers capable of competing will be smaller than in the conventional generic market, and price drops will likely be more moderate.

Another relevant point is medical acceptance. Many healthcare professionals are still hesitant to prescribe biosimilars, even when approved by regulatory agencies. This skepticism decreases as more real-world usage data are published, but the process takes time.

The Role of Technology in Biosimilar Production

Manufacturing a quality biosimilar is not just a matter of reverse engineering. Novo Nordisk and other companies that developed the originals guard valuable details about their production processes. These trade secrets are not described in the patents and need to be discovered or developed independently by the biosimilar manufacturer.

Advanced structural analysis platforms, artificial intelligence, and computational modeling have accelerated this process in recent years. Companies like Celltrion, Samsung Bioepis, and Sandoz are among those that have invested most in this capability and already have extensive biosimilar portfolios approved in multiple markets.

What This Means for GLP-1 Users

If you already use a GLP-1 medication or are considering starting treatment, the appearance of biosimilars on the market is positive news in the medium term. Competition tends to reduce costs and expand access, especially in public health systems and in countries where these medications are still inaccessible because they are too expensive.

Staying informed about the regulatory landscape and available options is a practical way to follow this transformation. Discussing biosimilars with your doctor is also advisable, as they can guide you on the specific situation of each approved product and on when it makes sense to consider the transition.

For those who want to better understand how individualized GLP-1 treatment assessment works, there are platforms that help identify which medication best fits each person's profile. You can take a short questionnaire and receive guidance based on your answers. The Ozempro app offers this resource in an accessible and no-obligation way.

The reality is that GLP-1 biosimilars are still arriving, but they will arrive. The regulatory pathway is established, investments are being made, and competition will push prices down in the coming years. Those who follow the landscape closely will be better prepared to take advantage of new options when they become available.

References

• EMA — Mounjaro (tirzepatida), EPAR
• Jastreboff et al., SURMOUNT-1 — NEJM (2022)