Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing

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Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing

INICIO/Noticias Farmacéuticas | Posted 16/05/2022 0 Post your comment

In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.

Biosimilar Solutions’ registrational clinical trials for BSC1020 and BSC0826, both a recombinant granulocyte colony-stimulating factor (G-CSF) analogue filgrastim, is designed to determine the similarity between the biosimilars and their reference product, Amgen’s Neupogen (filgrastim) and Neulasta (Pegfilgrastim), respectively. The design of the clinical trials of BSC1020 was reviewed and approved by the US Food and Drug Administration (FDA) and is planned to be completed in the summer of 2022.

Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

There are over 12 biosimilar filgrastim and 17 biosimilar pegfilgrastim approved for use worldwide [1].

Also, Biosimilar Solutions has entered into a long-term collaboration manufacturing and operations agreement with OcyonBio and has plans to complete a technology transfer to begin manufacturing in Puerto Rico in mid-March 2022. The plant will be located in Aguadilla, Puerto Rico, and it will include more than 95,000 sq ft of cleanroom and biomanufacturing space, with biosimilar production scheduled in 2022.

OcyonBio provides autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical and commercial start. Biosimilar Solutions expects to manufacture in-house commercial-scale facilities for recombinant proteins and monoclonal antibodies (mammalian, microbial cell culture, fill-finish for vials and syringes).

Robert Salcedo, CEO of OcyonBio said that with this partnership development manufacturing organization model OcyonBio will usher in these biosimilars to the US. Biosimilar Solutions will have efficient control over current good manufacturing practice (cGMP) production in a facility that has been designed to meet global regulatory expectations and readiness for the European Medicines Agency, FDA and global regulatory audits.

Biosimilars approved in the US

Biosimilars of filgrastim

Biosimilars of pegfilgrastim

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Nuevos biosimilares de adalimumab se preparan para su lanzamiento en Canadá, EE.UU. y Europa Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Nuevos biosimilares de adalimumab se preparan para su lanzamiento en Canadá, EE.UU. y Europa !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
1. Kang HN, et al. Biosimilars – status in July 2020 in 16 countries. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(1):4-32. doi: 10.5639/gabij.2021.1001.002

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