mAbxience and Amneal Enter Into an Agreement for Bevacizumab Biosimilar in the United States

The agreement to bring a biosimilar of bevacizumab to the United States will improve patient access and affordability of this important oncology treatment

MADRID, Spain I May 23, 2018 I mAbxience, a company specialized in the research, development, manufacturing and global commercialization of monoclonal antibody biosimilars, part of the Insud Pharma Group and Amneal Pharmaceuticals, Inc. (NYSE: AMRX), an integrated specialty pharmaceutical company powered by a robust U.S. generics business, have signed an exclusive licensing and supply agreement in the United States for mAbxience's bevacizumab, a biosimilar candidate for Avastin®.

Under the milestone based commercial agreement mAbxience will lead product, clinical development and subsequent manufacture while Amneal will guide the product through regulatory approval and have exclusive commercialisation rights in the United States.  

"We are very proud to deepen our partnership with Amneal with the bevacizumab biosimilar agreement. We are passionate about increasing access and affordability of biologics in all countries around the world and this latest agreement with Amneal will be an important contribution to public health in the United States," said Emmanuelle Lepine, General Manager of mAbxience.

mAbxience is progressing its international expansion, and recently established partnerships in Europe and Australia for its bevacizumab biosimilar. Building long lasting partnerships is central to the company´s business philosophy. Biosimilars bring patients a safe, effective, efficient and affordable treatment option, which contributes to the sustainability of healthcare systems worldwide. More than 10,000 patients have now been treated with a mAbxience biosimilar.

About mAbxience 

mAbxience is a biotechnology company specialized in the research, development and manufacture of biosimilar monoclonal antibodies, part to the pharmaceutical Insud Pharma Group. Set up in 2009, it currently has two facilities for development and production, in Spain and Argentina. In December 2014, it launched its first biosimilar, rituximab, which is now approved and distributed in many markets globally. Its second product, bevacizumab, was launched in its first market in November 2016.

mAbxience maintains a deep commitment to quality and safety. With a passion for patient care, access and affordability of biologics the mAbxience team is working to bring its biosimilars to all countries around the world. Its working methodology is "fingerprint-like, biosimilars by design", such that each product is highly similar to the original with the same genetic fidelity and precision as a human fingerprint.

Insud Pharma, founded in 1977, makes an enormous contribution to public health around the world through the medicines, and active pharmaceutical ingredients that it develops and manufactures. With over 6,000 employees based in over 40 countries, Insud Pharma is a significant and respected enterprise in the pharmaceutical and healthcare sector.

About Amneal 

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has approximately 6,500 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States, with an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. The Company markets a portfolio of branded pharmaceutical products through its Impax Specialty Pharma division focused principally on central nervous system disorders and parasitic infections. For more information, visit http://www.amneal.com

SOURCE: mAbxience

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