Meitheal Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (HKF) to market and distribute three biosimilars in the U.S. The agreement covers biosimilars for oncology medications pegfilgrastim and filgrastim as well as follitropin alpha in the fertility space.

Follitropin alpha is a form of recombinant human follicle-stimulating hormone (FSH) and is used to stimulate follicle development in women and spermatogenesis in men during fertility treatment. The infertility treatment market is large and growing – a branded formulation of FSH generated $847 million in sales in 2023 and there are currently no biosimilars for the gonadotropin follitropin alpha available in the U.S. 
 
Pegfilgrastim and filgrastim are bone marrow stimulants that support white blood cell production for patients receiving certain cancer treatments. The medications work by binding to G-CSF receptors to stimulate the proliferation, differentiation, and activation of neutrophils to fight infection. Filgrastim is dosed subcutaneously or intravenously daily for up to 14 days during a chemotherapy treatment cycle. Pegfilgrastim, a longer-acting form of treatment, is dosed subcutaneously once per treatment cycle. The U.S. market for pegfilgrastim and filgrastim is estimated at over $2.5 billion.
 
Hong Kong King-Friend Industrial Co. is a wholly owned subsidiary of NKF, founded in 2010. Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company engaged in R&D, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world’s manufacturers of heparin related APIs, NKF now supplies API and FDF in multiple therapeutic areas including critical care and oncology.

This agreement brings Meitheal’s total biosimilar portfolio to eight treatments.

“We are pleased to expand our biosimilars portfolio with this licensing agreement, which will allow us to deliver three more significant medications to patients in the U.S. at fair and sustainable prices,” said Tom Shea, Chief Executive Officer of Meitheal.