Lupin and Valorum Sign Licensing Agreement for Biosimilar in U.S.

Lupin Limited has announced an exclusive licensing agreement with Valorum Biologics for the biosimilar Armlupeg™ (pegfilgrastim-unne) in the United States. The agreement grants Valorum the rights to commercialize and distribute the biosimilar in the U.S. market. Lupin will be responsible for the manufacturing and supply of the product. This strategic move is part of Lupin’s efforts to enhance its presence in the U.S. biosimilars market.

Under the terms of the agreement, Lupin will receive an upfront license fee from Valorum. Additionally, Lupin is entitled to receive royalty payments based on the net sales of Armlupeg™ in the United States. The financial arrangements are designed to support Lupin’s manufacturing and supply responsibilities while allowing Valorum to focus on commercialization efforts.

The operational scope of the agreement involves Valorum advancing the commercialization and distribution of Armlupeg™. Lupin will handle the manufacturing processes to ensure a consistent supply of the biosimilar. Armlupeg™ is indicated for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy. This collaboration aims to provide an additional treatment option for healthcare providers and patients in oncology supportive care.

The market context for this agreement is significant, as the U.S. biosimilars market continues to grow. The partnership with Valorum allows Lupin to leverage Valorum’s expertise in the U.S. market, which is crucial for optimizing access and achieving cost savings in healthcare. The agreement aligns with Lupin’s strategy to expand its footprint in the biosimilars segment, particularly in the U.S., where there is a demand for affordable treatment options.

The timeline for the implementation of this agreement involves Valorum initiating the commercialization and distribution activities in the U.S. market. Lupin will continue to focus on the manufacturing and supply chain aspects to ensure timely availability of Armlupeg™. Both companies are committed to executing their respective roles efficiently to meet market demands.

Valorum Biologics is a specialized U.S. commercialization partner focused on maximizing the market potential of biosimilars. The company is dedicated to delivering best-in-class execution for regulatory approval, launch, and ongoing commercialization of complex biopharmaceutical products across the U.S. Valorum’s expertise in specialty markets is expected to facilitate the successful introduction of Armlupeg™ in the U.S.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin is committed to improving patient health outcomes and expanding its presence in the U.S. biosimilars market through strategic collaborations and partnerships.