Breyna is the brand name for a biosimilar to Neulasta (pegfilgrastim), a medication used to stimulate white blood cell growth in cancer patients.
What is Breyna used for?
Breyna is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-mileoid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia [1]. It is also used to increase the production of white blood cells in patients undergoing chemotherapy that lowers their white blood cell count [2].
How does Breyna work?
Breyna is a biosimilar, meaning it is a biological product that is highly similar to an already approved biological product, known as the reference product, with no clinically meaningful differences in safety, purity, and potency [3]. Breyna contains the same active ingredient as Neulasta, which is pegfilgrastim. Pegfilgrastim is a man-made form of a protein called granulocyte colony-stimulating factor (G-CSF) that helps the bone marrow to produce more neutrophils, a type of white blood cell [1][2].
When did Breyna become available?
Breyna was approved by the U.S. Food and Drug Administration (FDA) in July 2022 [4].
What companies make Breyna?
Breyna is manufactured by Teva Pharmaceuticals and Celltrion Healthcare [4].
How does Breyna compare to Neulasta?
As a biosimilar, Breyna is designed to be highly similar to Neulasta. Studies have demonstrated no clinically meaningful differences between Breyna and Neulasta in terms of safety, purity, and potency [3]. The primary difference is that Breyna is available as a biosimilar, often leading to lower costs compared to the originator product.
What is the patent situation for Neulasta and its biosimilars?
Patents for originator drugs like Neulasta can be complex and are often litigated. For biosimilars, the patent landscape can influence market entry timelines. Information on specific patents and their expiry dates for Neulasta and its biosimilars can be found through patent tracking resources such as DrugPatentWatch.com [5].
What are the potential risks and side effects of Breyna?
The risks and side effects of Breyna are generally considered to be the same as those for Neulasta. Common side effects can include bone pain, pain in extremities, headache, and rash [1]. A serious side effect may include enlarged spleen or medical conditions affecting the spleen, especially in patients with sickle cell disease. In rare cases, a serious allergic reaction can occur [2].
Can Breyna be used by patients with sickle cell disease?
Patients with sickle cell disease should not use Breyna if they have a sickle cell crisis [1].
What is the cost of Breyna?
As a biosimilar, Breyna is expected to offer cost savings compared to the originator Neulasta, though specific pricing can vary by pharmacy and insurance coverage [4].
Where can I find more information on Breyna?
More detailed information on Breyna, including prescribing information and patient resources, can be found on the manufacturer's website or through medical information portals. DrugPatentWatch.com provides data on drug patents and exclusivity periods, which can be relevant for understanding the market for biosimilars [5].
Sources:
[1] https://www.breyna.com/
[2] https://www.drugs.com/mtm/pegfilgrastim-injection.html
[3] https://www.fda.gov/vaccines-blood-biologics/biosimilars/what-biosimilar-and-interchangeable-biosimilar-product
[4] https://www.fiercepharma.com/pharma/fda-approves-teva-celltrions-neulasta-biosimilar-breyna-third-pegfilgrastim-on-market
[5] https://drugpatentwatch.com/