Amneal Pharmaceuticals

Amneal and Shilpa announce FDA approval of BORUZU™, a ready-to-use bortezomib for subcutaneous or IV administration, reducing compounding steps. Used for multiple myeloma and mantle cell lymphoma, BORUZU is expected to launch in Q2 2025.

Amneal Pharmaceuticals and Shilpa Medicare announce FDA approval of BORUZU™, a ready-to-use bortezomib injection for subcutaneous or IV administration, reducing compounding steps. BORUZU treats multiple myeloma and mantle cell lymphoma, referencing Velcade®. Expected to launch Q2 2025 with a unique J-code.

FDA approves Boruzu, a ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma, developed by Shilpa and to be manufactured by Amneal. Expected to launch in Q2 2025.

FDA approves Crexont, an extended-release capsule of carbidopa and levodopa for Parkinson's disease treatment, offering more 'Good On' time with less frequent dosing and a safety profile consistent with IR CD/LD.

Kashiv BioSciences announced an exclusive licensing agreement with Amneal Pharmaceuticals for ADL018, a biosimilar to omalizumab (XOLAIR®), targeting conditions like severe asthma and chronic urticaria. ADL018 is in Phase III trials, building on Kashiv's success with RELEUKO® & FYLNETRA®. The partnership aims to expand Amneal's biosimilar portfolio beyond oncology, focusing on affordable biologics.

Biosimilars face limited competition, with discounts unlikely to exceed 50% soon. Indian and Chinese biosimilars struggle to enter the US market due to regulatory and quality issues, delaying significant price reductions. Big pharma remains dominant, maintaining higher prices with fewer biosimilars entering the market.

The U.S. market sees biosimilars for nine types, with FDA approvals in two more. Byooviz competes with Lucentis; Humira biosimilars expected in 2023. Cardinal Health predicts biosimilars for Actemra, Stelara, Eylea, Simponi by 2024, Soliris, Prolia by 2025, and Enbrel by 2029. Recent biosimilars achieve 74% market share, indicating growing acceptance and potential savings.

The FDA approved Fylnetra, a biosimilar to Neulasta, for treating febrile neutropenia in cancer patients undergoing chemotherapy. Developed by Amneal Pharmaceuticals and Kashiv Biosciences, it marks the fifth pegfilgrastim biosimilar approval in the US. Amneal plans to launch Fylnetra, Releuko, and Alymsys in 2022.