The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
Amneal Pharmaceuticals has struck a $1.1 billion deal to buy Kashiv BioSciences, securing manufacturing capacity to support its ambition to become a global biosimilar leader.
New Jersey-based Amneal has a long-standing relationship with Kashiv, licensing biosimilar copies of Amgen’s Neulasta and Neupogen from the company in 2017. Amneal won FDA approval for both the drugs in 2022, which it sells as Fylnetra and Releuko, respectively. The companies expanded their relationship in 2024, when Amneal licensed a Xolair biosimilar from Kashiv. Amneal’s co-CEOs—brothers Chirag and Chintu Patel—directly or indirectly own half of Kashiv.
Amneal has agreed to buy Kashiv for $375 million in cash, $375 million in equity and up to $350 million in milestones, according to a Wednesday release. The deal will allow Amneal to integrate its biosimilar commercialization capabilities with the development and manufacturing infrastructure that already partly underpins its biologics business. Kashiv makes Fylnetra and Releuko at a facility in Chicago that has fill-finish capabilities.
The Illinois plant is one of four facilities Amneal will acquire through the deal. Kashiv runs a facility in New Jersey with 6,000 L of capacity to make monoclonal antibodies and fusion proteins, plus two plants in India. Amneal will expand the sites to support its pipeline, committing to establishing 50,000 L of capacity at one of the Indian plants and increasing the volume of the New Jersey facility to 24,000 L.
On an earnings call Wednesday, Amneal co-CEO Chintu Patel said drug substance capacity is expected to scale from 26,000 liters in 2026 to 75,000 by 2028. Patel added that Amneal anticipates $30 million to $50 million a year in capital expenditures to reach its capacity target.
Amneal’s investments are intended to ensure capacity rises in line with demand from new biosimilar launches. After buying Kashiv, Amneal’s pipeline will include six biosimilars that could come to market by next year. The Xolair biosimilar is the biggest of the opportunities, accounting for $4.6 billion of a $14 billion total. The New Jersey plant will make the Xolair copy, according to Amneal’s other CEO Chirag Patel.
The company could launch another six biosimilars with a total addressable market of $42 billion from 2028 to 2030. The figure reflects the almost $20 billion opportunity open to a copy of Merck’s Keytruda and the almost $10 billion market for a biosimilar version of Eli Lilly’s Trulicity.
Amneal, which has won approval for five biosimilars in the past three years, wants to deliver three to five products a year. The cadence may demand ongoing investments in manufacturing. Chirag Patel said that the infrastructure is designed to allow Amneal to keep adding another 25,000 liters as needed once it hits its current target of 75,000 liters.
