Amneal Sets $200m Sales Ambition For Biosimilar Trio
Looking To Expand Portfolio With Licensing Deals For Early-Entry Opportunities
Amneal management has offered additional detail on the firm’s burgeoning biosimilars business, revealing a “peak” sales estimate of $200m for its current roster of three products as well as indicating plans to expand its pipeline both through licensing and internal development.
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Amneal has received approval for its second US biosimilar in the form of the mAbxience-developed Alymsys rival to Avastin. The product represents just the third biosimilar version of bevacizumab to be approved in the US.
Amneal has laid out its plans to enter the US biosimilars market after receiving FDA approval for its first biosimilar, a Neupogen rival known as Releuko (filgrastim-ayow) that was developed with partner Kashiv Biosciences. Amneal also intends to launch two more biosimilars soon, along with 20-30 generics launches planned in 2022.
Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.