Innovative cancer
and supportive
care therapies
Oncology
Amneal Biosciences is committed to positively impacting the lives of patients living with cancer. Our oncology treatments and supportive-care products are streamlining access for appropriate patients who may need them.
Biosimilar products
Our biosimilar products allow for cost-effective and timely entrants into the oncology market.1
Ready-to-use oncology injectables
ALYMSYS® is a registered trademark of mAbxience Research, S.L.
FYLNETRA® and RELEUKO® are registered trademarks of Kashiv BioSciences, LLC.
PEMRYDI RTU® is a registered trademark and FOCINVEZ™ is a pending trademark of Amneal Pharmaceuticals LLC.
We believe PEMRYDI RTU®, the first ready-to-use version of pemetrexed, will offer a meaningful advantage to oncology practices, both through the efficiencies in the ready-to-use presentation and the value it will bring to the practices.
— Courtney Koster
Sr. Director, National Corporate Accounts
The 505(b)(2) regulatory pathway allows for changes to approved medicines that support operational efficiency
Amneal Biosciences is developing evolved formulations of injectable medicines through the 505(b)(2) pathway, which allows for changes in product characteristics that may support operational efficiency, such as ready-to-use formulations or other differences in dosage form, strength, or route of administration.2-4 As with all FDA-approved medicines, products approved under the 505(b)(2) pathway undergo rigorous evaluation of their efficacy, safety, and quality.5,6
References: 1. Carl DL, Laube Y, Serra-Burriel M, Naci H, Ludwig W-D, Vokinger KN. Comparison of uptake and prices of biosimilars in the US, Germany, and Switzerland. JAMA Netw Open. 2022;5(12):e2244670. 2. Amneal Pharmaceuticals. J.P. Morgan Healthcare Conference presentation. January 10, 2024. Accessed August 15, 2024. https://s22.q4cdn.com/186279204/files/
doc_presentations/2024/AMRX-2024-JPM-Presentation.pdf 3. Amneal Pharmaceuticals. Amneal receives 505(b)(2) NDA approval from FDA for PEMRYDI RTU®, a ready-to-use oncology injectable. June 14, 2023. Accessed August 15, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2023/Amneal-Receives-505b2-NDA-Approval-from-FDA-for-PEMRYDI-RTU-a-Ready-to-Use-Oncology-Injectable/default.aspx 4. US Food and Drug Administration. Overview of the 505(b)(2) regulatory pathway for new drug applications.
Accessed August 15, 2024. https://www.fda.gov/
media/156350/download 5. US Food and Drug Administration. Abbreviated approval pathways for drug product: 505(b)(2) or ANDA? Accessed August 15, 2024. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda 6. US Food and Drug Administration. Promoting safe & effective drugs for 100 years. February 2006. Accessed August 15, 2024. https://www.fda.gov/
about-fda/histories-product-regulation/
promoting-safe-effective-
drugs-100-years
