Amneal scores third biosimilar approval in three months

By Ben Hargreaves

- Last updated on GMT

Pic:getty/ultmodern
Pic:getty/ultmodern

Related tags: Amneal Pharmaceuticals, Biosimilars, Us, Fda

Amneal’s biosimilar to pegfilgrastim-pbbk receives US approval and the company plans to launch the product this year, under the name Fylnetra.

Amneal Pharmaceuticals, a generic drug specialist, has expanded its range of approved biosimilars to include three products, after previously receiving approval for Releuko​(filgrastim-ayow) and Alymsys​ (bevacizumab-maly).

Each biosimilar had been approved in successive months from March and the company stated that it expects to launch all three products onto the market over the second half of 2022, with a Q3 launch expected for the two earlier approved biosimilars.

Fylnetra is a biosimilar referencing Neulasta, Amgen’s product that is used to treat neutropenia, which is a condition that occurs in patients undergoing chemotherapy. The branded product managed full year 2021 sales of $1.5bn (€1.4bn) for Amgen.

Amneal brought its biosimilar on board through its acquisition of Kashiv Biosciences in 2021, with the price including a $70m fee upfront, alongside an additional payment of $30m and a potential further $8m in milestone fees.

The purchase brought both biosimilar products and manufacturing capabilities to Amneal’s portfolio, which added to its capabilities in biosimilar manufacturing dating back to the addition of a Johnson & Johnson Irish facility to network​.

L​ooking to the future

At the time of the acquisition of Kashiv, Co-CEOs, Chirag and Chintu Patel, stated that the transaction would be a step on the way to creating ‘Amneal 2.0’.

This transition in strategy has seen the company focus on ‘high growth’ areas, such as biosimilars and injectable drugs, the CEOs said during first quarter results in March. On the announcement of the third biosimilar approval, the CEOs referenced the $28bn biosimilar market and how biosimilars dovetail with the rest of the business by aligning with its mission of providing affordable medicine.

Amneal’s first quarter results for 2022 saw the company post a net loss of $2m on net revenue of $498m. The company had previously recorded net income of $7m in Q1 2021.

As a result of the financials, the share price of Amneal dropped by 12%, as the loss of exclusivity for its Zomig (zolmitriptan) nasal spray dampened sales.

However, Chirag Patel suggested in the earnings call on the financials that the company expects peak sales for its newly approved biosimilars to reach $200m, which was predicted to be achieved somewhere between 2023 and 2024.

The focus on biosimilars moves counter to a growing trend for companies to shift away from the space, as the difficulties with uptake in the US market persist​. Earlier this year, Viatris, another large generic drug manufacturer, chose to divest its biosimilars portfolio​ to Biocon Biologics, deeming the products ‘non-core’ to its future. An even larger company, in the form of Novartis, is carrying out a ‘strategic review’ of its entire generics and biosimilar business in Sandoz, with the company widely reported to be seeking a buyer for the unit.

Related topics: Bio Developments, Biosimilars

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