Meitheal adds three biosimilars to US offering with new agreement

Biopharmaceutical company Meitheal Pharmaceuticals has partnered with its parent company Hong Kong King-Friend Industrial (HKF), to market and distribute three biosimilars in the US. HKF is wholly owned by China-based Nanjing King-Friend Biochemical Pharmaceutical (NKF).

The exclusive commercial licensing agreement covers biosimilars for Neulasta (pegfilgrastim), Neupogen (filgrastim), and Gonal-f (follitropin). The former two drugs are each bone-marrow stimulants used in oncology, while the latter is a fertility medication used to promote egg and sperm development in women and men respectively.

The agreement expands Meitheal’s biosimilar portfolio to eight products, including treatments for cancer, infertility, diabetes, and autoimmune conditions.

“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 US at fair and sustainable prices,” said Tom Shea, CEO of Meitheal. “This expansion furthers our commitment to delivering cost-saving innovation to patients and the broader healthcare system.”

A spokesperson for Meitheal told BioProcess Insider that the expansion benefits from a robust internal infrastructure supported by the company’s generics business and the recent establishment of a specialty organization. “This includes a recent build-out of our specialty team, which we are now leveraging to support new product launches. Core functions, including legal, finance, regulatory, pharmacovigilance, operations, market access, and account management, are in place, and we’re expanding our medical affairs and brand-specific sales departments to accommodate acquired brands and biosimilars.

To meet its manufacturing needs, Meitheal is developing a product-specific training curriculum and bolstering its workforce. “Meitheal is expanding its organization by hiring additional experienced personnel outside of generics, investing in specialized consultants, and implementing new software to support our rapidly growing portfolio,” the spokesperson said.

The biosimilars will be manufactured by Meitheal’s parent company at scales designed to meet the demand for planned product launches. Drug substances will be produced by Kindos in Chengdu, with the drug product made by NKF in Nanjing, both in China. The manufacturing sites have had recent inspections by the US Food and Drug Administration (FDA).

HKF and related entities have invested “more than $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody (mAb) drug substance facility,” the spokesperson said. The company plans for its new therapies to be available to US patients in 2028.