STADA Strikes Deal With CuraTeQ For Neutropenia Biosimilars In Europe

• STADA reaches agreement with CuraTeQ to bring to European patients two neutropenia biosimilars
• STADA gains rights to market and distribute pegfilgrastim and filgrastim biosimilars, developed by CuraTeQ and approved in the EU; CuraTeQ is responsible for development, regulatory affairs, manufacturing and supply
• Bryan Kim, STADA’s Specialty head : “Pegfilgrastim and filgrastim will bring further therapeutic options to STADA’s extensive portfolio of 11 approved biosimilars, including bevacizumab and denosumab in oncology.”

STADA Arzneimittel AG has entered into a marketing and distribution agreement with CuraTeQ Biologics S.r.o, a subsidiary of Aurobindo Pharma Ltd focused on biosimilars, to bring to market two neutropenia biosimilars in Europe.

Under the terms of the agreement, STADA holds rights to market and distribute pegfilgrastim and filgrastim biosimilars, referencing Amgen’s Neulasta and Neupogen respectively, across key markets within the European Union (EU), including France and Germany. CuraTeQ’s responsibilities comprise development and regulatory affairs as well as manufacturing and supply from its EU Good Manufacturing Practice (GMP) certified plant in Hyderabad, India. STADA will market and distribute the products through its extensive and established commercial infrastructure in Europe. New brand names will be created and registered for each biosimilar.

By bringing to market the two G-CSF analog biosimilars, STADA will increase competition and thereby improve patient access in Europe.

Bryan Kim, STADA’s Specialty head, stated: “Pegfilgrastim and filgrastim will bring further therapeutic options to STADA’s extensive portfolio of 11 approved biosimilars, including bevacizumab and denosumab in oncology. Partnering with an established, GMP-certified developer and manufacturer in CuraTeQ provides a strong basis from which to broaden patient access in sizeable markets in which we have considerable experience and expertise.”

“STADA is a pioneer in biosimilars, having introduced one of the first biosimilars in Europe nearly 20 years ago,” Kim added. “With the addition of these important therapies in oncology, STADA is further expanding what is already one of the largest biosimilar portfolios, and we are serving more countries across Europe than our peers. With the strong support of our private-equity owners, STADA is well positioned to be the most effective commercial partner for aspiring biosimilar developers around the world.”

The European Commission in March 2025 issued to CuraTeQ a centralised marketing authorization for pegfilgrastim solution for injection pre-filled syringes that is valid in all EU and European Economic Area (EEA) member states.^[1] A centralised authorization for filgrastim was granted in February 2025.^[2]

^[1] Dec_165439_en.pdf (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://ec.europa.eu/health/documents/community-register/2025/20250328165439/dec_165439_en.pdf)

^[2] Dec_165114_en.pdf (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://ec.europa.eu/health/documents/community-register/2025/20250212165114/dec_165114_en.pdf)

About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in over 100 countries. In financial year 2025, STADA achieved group sales of € 4,296M and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 961M. As of 31 December 2025, STADA employed 11,670 people worldwide.