Amneal Pharmaceuticals Inc. has completed its acquisition of Kashiv BioSciences LLC, creating a fully integrated global biosimilars platform with capabilities spanning research, development, manufacturing and commercialisation.
The acquisition brings together Kashiv’s biologics research, development and manufacturing capabilities with Amneal’s commercial scale, positioning biosimilars as a major long-term growth pillar for the company’s affordable medicines business.
The combined business will have access to a global biosimilars opportunity supported by more than $300 billion of projected biologics loss-of-exclusivity over the next decade, according to the company.
Amneal expects the combined portfolio to support a consistent pipeline of biosimilar launches over the coming years.
Expanding into biosimilars
The acquisition marks a significant step in Amneal’s strategy to strengthen its position in affordable medicines and expand its presence in the rapidly growing biosimilars market.
The company said the combination creates one of the industry’s few fully integrated biosimilars platforms, bringing key capabilities across the value chain under one organisation.
Amneal Pharmaceuticals, Co-Founder and Co-Chief Executive Officer, Chirag Patel, said the completion of the acquisition marks a pivotal step in the company’s strategy to become America’s No. 1 affordable medicines company.
He said the integrated biosimilars business would enable Amneal to launch multiple biosimilars each year and extend its growth profile into the next decade.
Amneal Pharmaceuticals, Co-Founder and Co-Chief Executive Officer, Chintu Patel, said the company was pleased to welcome the Kashiv team and thanked shareholders and other stakeholders for their support.
He said the acquisition positions Amneal to capitalise on an unprecedented wave of biologic loss of exclusivity.
The combined organisation, he added, would pursue the opportunity while working to expand patient access to high-quality and affordable biologic medicines.
$300 billion market opportunity
The acquisition comes at a time when a large number of biologic medicines are expected to lose market exclusivity over the next decade.
Amneal estimates the global biologics loss-of-exclusivity opportunity at more than $300 billion, creating significant potential for biosimilar developers and manufacturers.
Biosimilars can provide lower-cost alternatives to complex biologic medicines, potentially improving access for patients while creating opportunities for pharmaceutical companies to build new revenue streams.
For Amneal, the Kashiv acquisition provides an opportunity to combine development and manufacturing capabilities with its commercial infrastructure and scale.
The company expects this combination to create a sustainable cadence of biosimilar launches and strengthen its growth outlook beyond its existing portfolio.
Integration gets underway
Integration planning and related activities are already underway, with the focus on combining the two companies’ development and manufacturing capabilities and advancing the biosimilar pipeline.
The transaction also builds on a relationship between Amneal and Kashiv that has spanned more than a decade, providing the companies with an existing foundation for integration.
Amneal said the combined capabilities are expected to strengthen its ability to move biosimilar candidates through development, manufacturing and ultimately commercialisation.
The company is looking to establish biosimilars as a major long-term growth pillar within its affordable medicines business.
Goldman Sachs & Co. LLC served as financial advisor and Richards, Layton & Finger, P.A. served as legal counsel to the Committee of Independent Directors of Amneal’s Board of Directors. Simpson Thacher & Bartlett LLP served as legal counsel, alongside other financial and compliance advisors, to Amneal.
J.P. Morgan Securities LLC served as financial advisor to Kashiv, while Holland & Knight LLP served as legal counsel and Dhinal Shah Associates served as an advisor in India.