Amneal Biosciences was created in 2014 as a division within Amneal Pharmaceuticals’ generic segment. The parent company was founded in 2002 as a generic pharmaceutical manufacturer by two brothers who had immigrated from India, Chirag and Chintu Patel. Amneal Biosciences is led by Executive Vice President and Chief Commercial Officer for Generics and Biosciences Andrew S. Boyer; Senior Vice President for Biosimilars and Branded Oncology Sean F. McGowan; and Senior Director, Oncology Marketing Victoria Myers.

Amneal Biosciences currently markets three biosimilar products (Alymsys^® [bevacizumab-maly], Releuko^® [filgrastim-ayow], and Fylnetra^® [pegfilgrastim-pbbk]) in addition to more than 40 injectable ready-to-use, generic, and specialty medications. In addition, the parent company produces more than 250 generic drugs. Amneal Biosciences’ mission is to reduce access barriers to prescribed therapies, while supporting a sustainable supply chain and delivering value.

Why you may be hearing more about Amneal Biosciences:

Amneal Biosciences is an experienced player as a marketing and commercialization partner for several biosimilar products. In April 2021, Amneal acquired the Kashiv Biosciences subsidiary Kashiv Specialty Pharmaceuticals. Currently, it markets two Kashiv-manufactured and FDA-approved granulocyte colony–stimulating factors agents (Releuko^® and Fylnetra^®).

A partnership arrangement with mAbxience resulted in Amneal’s commercialization and marketing of the bevacizumab biosimilar Alymsys^®, which is produced by mAbxience. In 2023, Amneal extended its partnership arrangement with mAbxience to market two denosumab biosimilars (reference products, Prolia^® and Xgeva^®) upon FDA approval. Furthermore, an omalizumab biosimilar candidate is currently in the pipeline, in collaboration with Kashiv Biosciences. In addition, Amneal Biosciences is working on an on-body injector and autoinjector forms of Fylnetra^® to add convenient administration routes to its portfolio.

Amneal may be very well positioned for the biosimilar arena. It has a strong heritage as a generic drug manufacturer that is well familiar with the multisource generics model, which generally yields lower revenues than conventional branded agents. Supported by the parent company’s broader generic product line, Amneal Biosciences’ participation in the biosimilar arena may be sustained for many years, in the face of an uncertain larger pharmaceutical environment in the US.

(September 26, 2025) Amneal Pharmaceuticals, Inc. announced the submission of a biologics license application to the FDA for a proposed biosimilar to Xolair^® (omalizumab), developed by Kashiv BioSciences, LLC. “The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents a significant potential growth catalyst in the coming years,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines at Amneal Pharmaceuticals.

(July 1, 2025) In preparation for anticipated 2026 launches in the US for an omalizumab biosimilar, we are monitoring the developments of some of the leading candidates. Top-line, preliminary phase 3 results were released June 25 by partners Amneal Pharmaceuticals and Kashiv Biosciences for ADL-018, their progressing omalizumab biosimilar.

(May 1, 2025)  Sean McGowan, Amneal Pharmaceuticals, pointed out that the Inflation Reduction Act (IRA) maximum fair price provisions also may threaten the biosimilar pipeline. “The IRA may cut the reference product’s net price by 20% or 30% immediately, years before the biosimilar even gets to compete,” he said.

(March 3, 2025) Amneal Pharmaceuticals, Inc, a global biopharmaceutical company, and mAbxience announced that the U.S. Food and Drug Administration has accepted for review its Biologics Licensing Application for two proposed denosumab biosimilars referencing Prolia^® and XGEVA^®.

(October 12, 2023) Under the terms of the agreement, mAbxience will conduct the full development of the two biosimilar candidates and manufacture them in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the products through regulatory approval and have exclusive commercialization rights in the United States. 

(May 31, 2022) On May 27, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration granted approval to Fylnetra™ (pegfilgrastim-pbbk), a new biosimilar that will launch later this year. Amneal has been busy this year in the biosimilar area: This is its third biosimilar approval since January 1, 2022.

(April 15, 2022) On March 1, Amneal announced that it had entered the biosimilar market with the FDA approval of its filgrastim biosimilar (Releuko^®). On April 14, the company announced another major step on its biosimilar journey: the approval of its second biosimilar, a new version of bevacizumab.