Meitheal Pharmaceuticals, Inc. announced it has 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 US. The agreement covers biosimilars for oncology medications pegfilgrastim and filgrastim as well as follitropin alpha in the fertility space.
“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. “This expansion furthers our commitment to delivering cost-saving innovation to patients and the broader healthcare system.”
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. As a result, follitropin alpha has the potential to fulfill the significant unmet need for more affordable treatment options for women trying to conceive.
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.
“We are pleased that Meitheal will be developing and commercializing follitropin alpha, pegfilgrastim, and filgrastim in the U.S. and that our partnership will increase access to these critical medications,” said Eric Tang, President of HKF. “We are continuing to invest in biosimilar innovation and we look forward to supporting Meitheal’s growing capabilities and portfolio in this important space.”
Meitheal’s parent company and related entities have invested over $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody drug substance facility. This agreement adds three biosimilars, bringing Meitheal’s total biosimilar portfolio to eight treatments.
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