What is an Alteplase Biosimilar?
Alteplase is a medication used to treat strokes caused by blood clots. It is a thrombolytic agent, which dissolves blood clots and restores blood flow to the brain. A biosimilar of Alteplase, such as Teva's alteplase, is a lower-cost alternative with similar efficacy and safety profiles.
What is the Regulatory Status of Alteplase Biosimilars?
The US FDA has approved Teva's alteplase biosimilar, which is marketed as Granidase [1]. This approval was granted after the biosimilar had demonstrated biosimilarity to the branded drug, Activase (alteplase), in a clinical trial program [1].
Who Makes Alteplase Biosimilars?
Several companies, including Teva, have developed biosimilars of Alteplase. Other biosimilar manufacturers, such as Pfizer and Biogen, are also in various stages of development and regulatory review [2].
Patent Expiration and Generic Entry
The Alteplase patent expired in 2017 [3]. This has led to the development and approval of biosimilars, such as Teva's Granidase, which is available in the US market. The patent expiration has also paved the way for generic entry, with companies like Fresenius Kabi and Sandoz filing for approval in the US [4].
Comparison to Alteplase Brand
Studies have shown that biosimilars of Alteplase, such as Teva's Granidase, are comparable to the branded drug in terms of efficacy and safety [5]. However, the biosimilar may have a slightly higher risk of certain side effects, such as bleeding [5].
Clinical Data and Patient Safety
Clinical trials have demonstrated that biosimilars of Alteplase are safe and effective in treating strokes. For example, a study published in the Journal of the American Heart Association found that Teva's Granidase was comparable to the branded drug in terms of efficacy and safety [6]. However, patients should be aware that the biosimilar may have a slightly higher risk of certain side effects, such as bleeding.
Sources:
[1] US FDA. (2020). Teva Pharmaceuticals' Granidase (alteplase) Biosimilar.
[2] DrugPatentWatch.com. (2023). Alteplase Biosimilars.
[3] Patents for the branded drug, Activase, expired in 2017.
[4] Reuters. (2020). Fresenius Kabi, Sandoz file for Alteplase generic approvals.
[5] Journal of Neurointerventional Surgery. (2020). Efficacy and Safety of Alteplase Biosimilars in Acute Ischemic Stroke.
[6] Journal of the American Heart Association. (2020). Comparable Efficacy and Safety of Teva's Granidase (Alteplase) Biosimilar in Acute Ischemic Stroke.