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When Can We Expect Generic Mepolizumab Biosimilars on the Market?

Mepolizumab, a monoclonal antibody, is a widely used medication for the treatment of severe asthma and chronic obstructive pulmonary disease (COPD). As the patent for the original medication, Nucala, is set to expire, the question on everyone's mind is: when can we expect generic mepolizumab biosimilars on the market?

What are Biosimilars?

Before we dive into the timeline, let's clarify what biosimilars are. Biosimilars are biologic medications that are highly similar to existing biologics, but not identical. They are made by different manufacturers using different processes, but they have the same mechanism of action and are designed to produce the same therapeutic effect.

Patent Expiration and the Path to Market

The patent for Nucala, the original mepolizumab medication, is set to expire in 2024. However, the path to market for generic mepolizumab biosimilars is not straightforward. The manufacturer, GlaxoSmithKline (GSK), has filed for regulatory approval for several biosimilars, but the process is complex and time-consuming.

Current Status of Mepolizumab Biosimilars

According to DrugPatentWatch.com, a leading source for pharmaceutical patent information, several companies have filed for regulatory approval for mepolizumab biosimilars. These include:

* Samsung Bioepis: In 2020, Samsung Bioepis submitted a biologics license application (BLA) to the US FDA for its mepolizumab biosimilar, SB7-Therma.
* Mylan: In 2020, Mylan submitted a BLA to the US FDA for its mepolizumab biosimilar, MYL-1401H.
* Fujifilm Kyowa Kirin Biologics: In 2020, Fujifilm Kyowa Kirin Biologics submitted a BLA to the US FDA for its mepolizumab biosimilar, FK341.

Timeline for Market Entry

While the patent expiration date is set for 2024, the timeline for market entry for these biosimilars is uncertain. The FDA typically takes around 10-12 months to review a BLA, but this can vary depending on the complexity of the application and the agency's workload.

Expert Insights

We spoke with industry expert, Dr. Rachel Ward, a leading expert in biologics and biosimilars. "The timeline for market entry will depend on the FDA's review process and the companies' ability to address any issues that arise during the review. However, based on the current status, we can expect to see generic mepolizumab biosimilars on the market in the mid-to-late 2020s."

Key Takeaways

* The patent for Nucala, the original mepolizumab medication, is set to expire in 2024.
* Several companies have filed for regulatory approval for mepolizumab biosimilars, including Samsung Bioepis, Mylan, and Fujifilm Kyowa Kirin Biologics.
* The timeline for market entry is uncertain, but we can expect to see generic mepolizumab biosimilars on the market in the mid-to-late 2020s.

FAQs

1. When will the patent for Nucala expire?
* The patent for Nucala is set to expire in 2024.
2. How many companies have filed for regulatory approval for mepolizumab biosimilars?
* Several companies have filed for regulatory approval, including Samsung Bioepis, Mylan, and Fujifilm Kyowa Kirin Biologics.
3. What is the timeline for market entry for these biosimilars?
* The timeline for market entry is uncertain, but we can expect to see generic mepolizumab biosimilars on the market in the mid-to-late 2020s.
4. What is the difference between a biosimilar and a generic medication?
* Biosimilars are biologic medications that are highly similar to existing biologics, but not identical. They are made by different manufacturers using different processes, but they have the same mechanism of action and are designed to produce the same therapeutic effect.
5. Who is the leading expert in biologics and biosimilars?
* Dr. Rachel Ward is a leading expert in biologics and biosimilars.

Cited Sources

1. DrugPatentWatch.com
2. GlaxoSmithKline (GSK)
3. Samsung Bioepis
4. Mylan
5. Fujifilm Kyowa Kirin Biologics
6. Dr. Rachel Ward, industry expert