Norbitec’s biologics facility in Uetersen, Germany will supply Retacrit – Pfizer’s biosimilar of anemia drug Epogen (epoetin alfa) – to the US market.
The approval for Retacrit in May 2018 brought the first US challenge to Amgen’s Epogen. Five years on and Pfizer has made a significant dent in the market, with the epoetin alfa biosimilar pulling in $312 million in US sales in 2022.
Pfizer’s manufacturing facility in McPherson, Kansas – added through the $17 billion Hospira acquisition in 2015 – is approved to produce Retacrit, but another site has been added, it has been announced this week.
Contract development and manufacturing organization (CDMO) Norbitec biotech, a joint venture between generics firm Stada and biologics firm Nordmark, will supply Pfizer with Retacrit from its site in Uetersen, about 20km northwest of Hamburg, Germany for the US market, following accreditation from the US Food and Drug Administration (FDA).
“Norbitec employs modern recombinant mammalian cell-culture technology specifically tailored to producing epoetin to US and EU GMP standards,” a spokesperson from the manufacturing firm told BioProcess Insider.
“Considerable effort has been invested to building the capabilities, systems, and processes to meet the FDA expectations and support patients who need this product. This has involved extensive cross-disciplinary collaboration between STADA, Nordmark and external parties. While some financial expense has been incurred, the investment has also been in time and management attention to ensuring that FDA as well as EU standards are met.”
Specifics regarding capacity allocation have not been divulged, but we were told “all necessary actions to support demand for Retacrit in the US.”
The deal is an extension of a long-standing partnership with Norbitec already supplying epoetin drug substance for sales in Europe.
“This FDA accreditation serves as a further proof point of STADA’s rapid progress as a leader in Specialty medicines and of the Group’s commitment to ensuring patients around the world have sustainable access to high-quality medicines,” STADA’s CEO Peter Goldschmidt said in a statement. “We look forward to extending our successful strategic partnership for Retacrit to safeguard epoetin supplies in the US.”