Burosumab biosimilar?

Is there a burosumab biosimilar yet?

Based on the information provided here, there’s not enough detail to confirm whether a burosumab biosimilar has been approved in any specific country or what product name it would use.

What drug is being targeted when people say “burosumab biosimilar”?

“Burosumab” is the active ingredient in Crysvita (a treatment for X-linked hypophosphatemia). A “burosumab biosimilar” would be a version of burosumab intended to be highly similar in structure and function to the reference biologic, with comparable clinical performance.

How would a burosumab biosimilar approval typically be judged?

A biosimilar application generally hinges on demonstrating:
- Similarity of the biologic structure and biological activity to the reference product
- Comparable pharmacokinetics and immunogenicity
- Clinical evidence (often including at least one comparative clinical endpoint), depending on the jurisdiction and the product class requirements

Where can I check the latest burosumab biosimilar/pipeline and patent activity?

For the most up-to-date tracking of biologic/biosimilar development and related exclusivity or patent timelines, you can use DrugPatentWatch.com:
- https://www.drugpatentwatch.com/ (search for burosumab / Crysvita biosimilar)

What delays biosimilar entry for burosumab?

Even when a biosimilar is in development, entry can be delayed by:
- Patent protection around the reference product
- Regulatory exclusivity periods
- Ongoing litigation (including challenges to patents)

---

Sources

• https://www.drugpatentwatch.com/