Agalsidase beta manufacturers

About agalsidase beta

Agalsidase beta manufacturers include the originator Sanofi (Fabrazyme, developed by Genzyme), ISU Abxis in Korea, JCR Pharmaceuticals in Japan and Petrovax in Russia. Agalsidase beta is a recombinant form of the human enzyme alpha-galactosidase A, used as long-term enzyme replacement therapy for Fabry disease. Pharmaceutical companies can source agalsidase beta lyophilised powder for infusion through out-licensing, supply or technology transfer. Biosimilar dossiers are available in national formats in Korea, Japan and Russia.

Agalsidase beta key facts

Agalsidase beta manufacturers and licensing history

Genzyme developed agalsidase beta as Fabrazyme. The European Commission granted an EU-wide marketing authorisation on 3 August 2001, initially under exceptional circumstances because Fabry disease is rare. The FDA approved Fabrazyme on 24 April 2003. Sanofi now holds the product after acquiring Genzyme.

Biosimilars have so far been approved only outside the US and EU. ISU Abxis's agalsidase beta biosimilar has been used in South Korea since 2014. JCR Pharmaceuticals markets an agalsidase beta biosimilar in Japan. In Russia, Petrovax's Fabagal was approved in 2023 and is fully manufactured in Russia, from cell line to finished product. Biosidus of Argentina is developing a biosimilar, to be manufactured by mAbxience.

Agalsidase beta is made in CHO cell culture. Buyers should confirm comparability data on glycosylation and enzyme activity, GMP status and cold-chain capability before choosing a licensing partner.

Agalsidase beta dosage forms and dossier types

Agalsidase beta is supplied as lyophilised powder in 5 mg and 35 mg vials, reconstituted and diluted for intravenous infusion. Biosimilar agalsidase beta manufacturers develop the same vial strengths, referencing Fabrazyme.

Agalsidase beta regulatory and patent status

Fabrazyme received its EU authorisation on 3 August 2001, renewed in 2006, and US FDA approval on 24 April 2003. It was first authorised in the EU under exceptional circumstances because limited data were available for this rare disease.

Biosimilars have been approved in Korea, Japan and Russia, but none yet in the EU or US. Check national patent registers for manufacturing and formulation patents before filing.

Agalsidase beta mechanism of action and therapeutic use

Agalsidase beta replaces the missing enzyme alpha-galactosidase A. This allows cells to break down globotriaosylceramide (GL-3), which builds up in Fabry disease and damages the kidneys, heart and nerves. Agalsidase beta is given at 1 mg/kg every 2 weeks by infusion for long-term treatment of confirmed Fabry disease.

Agalsidase beta licensing and sourcing

Agalsidase beta suppliers and licensing partners typically offer biosimilar dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status, comparability data, cold-chain capability and territory availability. Current offers and supplier contacts are listed among the agalsidase beta manufacturers on Pipelinepharma.

Frequently asked questions about agalsidase beta

Who are the main agalsidase beta manufacturers? Sanofi makes the originator, Fabrazyme, developed by Genzyme. Biosimilars are made by ISU Abxis in Korea, JCR Pharmaceuticals in Japan and Petrovax in Russia.

Is there a biosimilar of agalsidase beta? Yes. Agalsidase beta biosimilars are approved in Korea, Japan and Russia, where Fabagal was approved in 2023. No biosimilar has yet been approved in the EU or US.

Is an agalsidase beta dossier available for licensing? Agalsidase beta biosimilar dossiers are available in national formats for markets such as Korea, Japan and Russia. EU and US filings would need full biosimilar comparability data against Fabrazyme.

What forms and strengths of agalsidase beta are available? Agalsidase beta is available as lyophilised powder in 5 mg and 35 mg vials for intravenous infusion.

When was agalsidase beta first approved? The EU approved Fabrazyme on 3 August 2001, and the US FDA approved it on 24 April 2003.