Two biological drugs manufacturing facilities for biosimilar epoetin alfa and biosimilar bevacizumab were approved in the US and Europe in May and April 2023, respectively.
The Norbitec biologics facility, a STADA controlled entity, in Uetersen, Germany, was approved by the US Food and Drug Administration (FDA) as a manufacturing and storage site for Pfizer's biosimilar Retacrit (epoetin alfa-epbx). This followed news that the Biocon Biologics monoclonal antibody drug substance manufacturing facility in Bengaluru, India meets good manufacturing practice (GMP) standards for biosimilar bevacizumab production, as announced by Ireland’s Health Products Regulatory Authority.
Manufacture and storage of Retacrit
Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy [1].
Retacrit was first approved in Europe in December 2007 and the US in May 2018 [1], and is an important biosimilar therapy for anaemia associated with chemotherapy and chronic kidney disease that has annual US sales in excess of US$300 million.
Norbitec is a joint venture between STADA’s Bioceuticals Arzneimittel AG subsidiary and Nordmark Pharma GmbH, Norbitec is located on Nordmark’s campus in Uetersen, near Hamburg.
Through the FDA certification, STADA will be able help ensure continued US patient access to one of the top-selling biosimilars in the US.
Manufacture of Biocon Biologics bevacizumab biosimilar
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [2]. It is also used ‘off-label’ to treat some eye diseases.
The originator product, Roche’s Avastin (bevacizumab), was approved by FDA in February 2004 and by the European Medicines Agency (EMA) in January 2005 [3].
Biocon Biologics’ Indian multi-product facility will produce biosimilar bevacizumab for export to the EU. It also received EU authorization in 2022 to manufacture trastuzumab and received an honourable mention in the International Society for Pharmaceutical Engineering's 2021 Facility of the Year Award.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 6]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-epoetin-alfa
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 6]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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