FDA Approves 34th Biosimilar


Lo and behold…… the FDA approved yet another biosimilar to Filgrastim.
This follow-on product joins two previously approved biosimilars to Neupogen and was christened Releuko (filgrastim-ayow) from Amneal Pharmaceuticals and Kashiv Biosciences. It is the first biosimilar for Amneal, which is in development of two additional biosimilars expected later this year.

Filgrastim-ayow is indicated for febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs, for expedited neutrophil recovery, related clinical sequelae and severe neutropenia.

However, Releuko comes with warnings and precautions such as fatal splenic rupture, acute respiratory distress syndrome, allergic reactions including anaphylaxis, myelodysplastic syndrome, thrombocytopenia, and serious reactions in patients with Sickle cell.

Releuko enters a competitive segment win the market against brand Neupogen and biosims Zarxio (approved 03/2015) and Nivestym (07/2018)and. Releuko pricing was not available at time of the announcement. By way of reference, the approved filgrastim biosimilars, both of which are available commercially, are priced at only ~15% discount to the brand.

Kashiv, Amneal Receive First FDA Approval for Their Filgrastim Biosimilar

March 3, 2022 — Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022.

The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the third filgrastim biosimilar to be approved for the US market.

The product is also the first biosimilar to receive FDA approval for the Kashiv and Amneal teams and represents the first FDA biosimilar approval of 2022. The companies said that they expect to launch the product during the third quarter of 2022.

“The US approval of our first biosimilar is a very significant milestone for Amneal. Biosimilars represent the next wave of providing access to affordable medicines in the United States. We are building a global biosimilars business by leveraging partner assets to start and then leveraging our own key capabilities over time. Our goal is to become a meaningful long-term player in biosimilars,” said Chirag and Chintu Patel, co–chief executive officers of Amneal, in a statement.

The biosimilar will be used in patients with cancer undergoing chemotherapy who are at risk for developing febrile neutropenia, a common complication related to chemotherapy where the level of neutrophils in a patients’ blood stream are too low.

“It is a proud moment for the Kashiv team and our partners at Amneal to have our first biosimilar, Releuko, approved by the US FDA. Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. Kashiv aims to continue bringing high-quality biosimilars to the global markets over the coming years. I would like to extend a humble ‘thank you’ to our highly talented team, without whom this would not have been possible,” said Chandramauli Rawal, MBBS, chief operating officer for Kashiv, in a statement.

The companies are also working together to develop 2 other oncology biosimilars: a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin. They said they hope to launch them in 2022 and that both are under review by the FDA.

Releuko was approved for administration for intravenous and subcutaneous use, either as single-dose vials or prefilled syringes, both of which come in a 300-mcg/mL dose and 480-mcg/1.6 mL dose.

Under the agreement between Kashiv and Amneal, Kashiv will be handling the US launch and the manufacturing. In January 2021, Amneal and Kashiv announced an agreement under which Amneal would acquire a 98% interest in Kashiv’s specialty pharmaceuticals division. Kashiv Biosciences is headquartered in Piscataway, New Jersey, but has facilities in Chicago, Illinois. Amneal is based in Bridgewater, New Jersey.

Kashiv Biosciences was originally established in 2006 as Therapeutic Proteins, according to founder and consultant for the company, Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board. The company’s name was changed in 2014 to Adello Biologics and then to Kashiv Biosciences.

Skylar Jeremias, Center for BIosimilars


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