Amneal Pharmaceuticals, Inc.
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Latest From Amneal Pharmaceuticals, Inc.
Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.
Amneal highlighted the benefits of a broad spread of generics and an increased shift towards complex products with high barriers to entry, as it reported generics sales growth in Q1 despite a tough operating environment for US generics.
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.
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- Amedra Pharmaceuticals LLC
- Amneal Pharmaceuticals, LLC
- CorePharma LLC
- Gemini Laboratories, LLC
- Impax Generics
- Impax Laboratories, Inc. (IPXL)
- Impax Specialty Pharma
- Lineage Therapeutics Inc.
- Tower Holdings, Inc.