Amneal, Kashiv Launch Filgrastim Biosimilar, Releuko

About 10 months after the FDA approved the drug, Releuko (filgrastim-ayow), a biosimilar referencing Neupogen (filgrastim), is now on the US market. The drug developed by Kashiv Biosciences and Amneal Pharmaceuticals is the fourth filgrastim product to enter the market.

Filgrastim products are granulyte colony-stimulating factors used to treat and prevent febrile neutropenia in patients with cancer undergoing chemotherapy. Releuko is the second biosimilar developed by Amneal Pharmaceuticals and Kashiv Biosciences to launch.

“This product is another important oncology therapeutic offering for providers and their patients as we look to make essential medicines more accessible for all,” said Harsher Singh, senior vice president of Amneal Pharmaceutical’s biosciences division, in a company statement.

Releuko was approved in March 2022 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. According to research from IQVIA, the US sales for all filgrastim products for the 12 months prior to August 2022 were $390 million, of which biosimilars accounted for $272 million.

Releuko launches after Zarxio (filgrastim-sndz), Granix (tbo-filgrastim), and Nivestym (filgrastim-aafi). Zarxio launched in September 2015 as the first biosimilar in the United States; it was also the first biosimilar in the European Union. Although Granix is by definition a biosimilar, it is not legally classified as a biosimilar because it was developed and approved prior to the establishment of the biosimilar approval pathway outlined in the Biologics Price Competition and Innovation Act. Nivestym launched in October 2018 and had the shortest approval-to-launch time (3 vs 5 [Zarxio] vs 10 [Releuko] vs 15 months [Granix]).

Kashiv Biosciences and Amneal Pharmaceuticals have 2 other biosimilars in their portfolio: a pegfilgrastim biosimilar (Fylnetra), which was approved by the FDA in May 2022, and a bevacizumab biosimilar (Alymsys), which was approved in April 2022. Alymsys launched in October 2022 for the treatment of several kinds of cancer. Fylnetra is expected to launch during the second half of 2022.

Additionally, Kashiv has 7 biosimilars in its pipeline that will be used in immunology and respiratory, digestive care, cardiovascular conditions, type 2 diabetes, and fertility hormone therapy.

Financial Performance

In its third quarter of 2022 earnings report, Amneal said that it achieved a net revenue of $546 million, an increase of 3.2% compared with the same quarter in 2021 ($529 million). The company said that the growth stemmed from the “consistent performance of Generics and Specialty [divisions], and double-digit growth of AvKARE [its generic pharmaceutical manufacturer].”

“Third quarter results reflect continued solid performance across our diversified portfolio. Over the last several years, we have driven our growth strategy through new product innovation, leveraging key capabilities, and strong execution… As we successfully execute on our strategic priorities, we see our momentum building,” said Chirag and Chintu Patel, co-CEO of Amneal, in a statement.