Promotion of biosimilar product development in Puerto Rico

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Promotion of biosimilar product development in Puerto Rico

Biosimilars/General | Posted 17/10/2023 0 Post your comment

The Puerto Rico Economic Development Bank (Banco de Desarrollo Económico para Puerto Rico, BDE)announced in August 2023 a funding of US$3.85 million for Biosimilar Sciences PR, LLC (Biosimilar Sciences) and Ocyon Bio PR Inc (OcyonBio) to facilitate the purchase of specialized biotechnology equipment. This funding comes from the State Small Business Credit Initiative (SSBCI) of the US Treasury for Small Businesses.

This financing is the first granted in partnership with a private financial entity, in collaboration with Cooperativa de Ahorro y Crédito Jesús Obrero (Jesús Obero Savings and Credit Cooperative), highlighting the teamwork between both institutions. Biosimilar Sciences and OcyonBio are developing a biosimilar of AbbVie's Humira® (adalimumab).

At the end of March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the initiation of their pivotal clinical trials for the biosimilar filgrastim BSC1020 and BSC0826. On 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop pharmaceutical biosimilar production facilities for Biosimilar Solutions in Puerto Rico [1].

Biosimilar Sciences and OcyonBio were founded with the purpose of developing four bioequivalent products of the following medicines: GCSF (Neupogen), PEG-GCSF (Neulasta), Darbepoetin (Aranesp) and Adalimumab (Humira). These drugs are crucial for patients undergoing cancer treatments. Additionally, the company will also focus on producing bioequivalent therapies, COVID-19 vaccines, and stem cell therapies.

Thanks to the financial support provided by the BDE, Biosimilar Sciences will be able to acquire specialized equipment, increase its manufacturing capacity, and play a key role in the growth and advancement of the pharmaceutical industry in Puerto Rico. Furthermore, Biosimilar Sciences will use this funding to acquire three filling machines known as Aseptic Filling Workcells. These machines, manufactured by renowned suppliers in the pharmaceutical industry such as Marchesini and Baush & Strobel, have specific production capacities, including 900 syringes per hour, 11,400 syringes or cartridges per hour, and 4,300 vials per hour.

As stated by the president of the BDE, Alemañy González, the equipment they are acquiring ‘represents a significant advancement in continuing to position Puerto Rico as a logical option for reshoring companies to American territory. This will allow the first biosimilars to be produced on the island.’

In Puerto Rico, manufacturing leads the economy, contributing 43% to the GDP in 2022, with the pharmaceutical industry playing a crucial role. Pharmaceuticals account for 75.2% of exports, totallingUS$46.321 billion, and 22.4% of imports, amounting to US$12.079 billion. Furthermore, the chemical sector saw a 5.6% increase in employment in 2022, underscoring the economic significance of the pharmaceutical industry on the island.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from:
www.gabionline.net/pharma-news/biosimilar-solutions-to-start-trials-of-biosimilar-filgrastim-and-gmp-manufacturing

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