Amneal to leverage Indian network to enter biomanufacturing space

With a robust biosimilars pipeline and an increasingly large footprint, Amneal is preparing to invest in biologics manufacturing capabilities.

Amneal Pharmaceuticals has developed and commercialized numerous small molecule drugs and generics but according to the Indian press the firm is on the verge of entering the biomanufacturing space with a greenfield biologics plant in Ahmedabad on the cards.

The interest in biologics was confirmed by Amneal spokesman Anthony Di Meo, but he said plans have not been finalized.

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“In terms of capital expenditures, we spend $60-70 million per year as a company,” he told BioProcess Insider. “In terms of expanding manufacturing into biologics, we haven’t yet disclosed our strategy, but it’s right to think that with eight manufacturing facilities and deep R&D expertise in India, we have a significant footprint and capabilities to leverage.”

The firms presence in India include two oral solid dose and two injectable plants in Ahmedabad, along with a third site added through the acquisition of Puniska Healthcare earlier this month, which “significantly enhances the Company’s injectables manufacturing infrastructure, capabilities, and capacity to support the US market and serve as a foundation for expansion into international markets,” Di Meo added.

Meanwhile, Amneal’s focus on biosimilar over the past few years is also stirring the push for investing in biologics capacity.

“Our near-term focus is on developing biosimilar versions of three well-known oncology drugs through partnership. Our biosimilar versions of [Amgen’s] Neupogen, Neulasta and [Roche’s] Avastin have been filed with the FDA, and we expect to start commercializing in 2022,” we were told.

“We’ll seek to continue building this business through collaborations with select partners to pursue well targeted biosimilar opportunities. Longer-term, we’ll look to grow capabilities to drive this business organically.”