EU, Brazil Advance Hematology, Oncology Biosimilars

The European Union advances an eculizumab biosimilar in its regulatory process and the Brazil Agência Nacional de Vigilância Sanitária (ANVISA) advanced a bevacizumab biosimilar.

EU Thumbs Up for Eculizumab Biosimilar

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on Bekemv, an eculizumab biosimilar referencing Soliris, bringing the drug one step closer to regulatory approval in the European Union.

Eculizumab is a recombinant humanized monoclonal IgG4/4k antibody that binds to the human C5 complement protein to inhibit the activation of terminal complement. It’s used to treat adults and children with paroxysmal nocturnal hemoglobinuria. Bekemv was developed by Amgen, and if approved, it would be the first biosimilar referencing Soliris to be granted marketing authorization in Europe.

Bekemv will be available as a 300-mg concentrate designed for intravenous infusion. The biosimilar would need to be administered by a health care professional and under physician supervision. Unlike the reference product, Bekemv contains sorbitol and is therefore contraindicated in patients with hereditary fructose intolerance (HFI), who may experience serious metabolic harms if exposed to sorbitol. It is also contraindicated in children younger than 2 years who have not yet received a diagnosis of HFI.

The opinion was based on data from a phase 3 study submitted in the marketing authorization application for Bekemv, which demonstrated that the biosimilar has no clinically meaningful differences from the originator.

ANVISA Accepts Bevacizumab Biosimilar Application

ANVISA accepted an application for Boan Biotech’s Boyounuo, a biosimilar referencing Genentech’s Avastin (bevacizumab). Boan Biotech is a Yantai, China–based company that develops biologics for the Chinese market as well as international markets.

Bevacizumab is a vascular endothelial growth factor inhibitor used to treat colorectal, non–small cell lung, glioblastoma, kidney, cervical, and ovarian cancers. Boyounuo launched in China in 2021 and Boan Biotech said that it is accelerating the commercial launch of the product overseas.

The Brazilian drug market was named the eighth largest pharmaceutical market in the world in 2021 by IQVIA, and it is expected to grow to be the sixth largest by 2026. Invoice spending on pharmaceutical products in Brazil is expected to reach between $47 billion and $51 billion in 2026. Currently, there are 43 ANVISA-approved biosimilars in Brazil.

In terms of the needs of local patients, data from the World Health Organization's International Agency for Research on Cancer show that, in 2020, lung cancer and colorectal cancer were among the top 5 cancers in terms of new cases in Brazil, indicating an unmet need for affordable treatments in the country.

“At Boan Biotech, we're committed to serving patients around the world with high-quality biologics. Our products are developed to address worldwide clinical needs following international quality standards. Fast-growing emerging markets including Brazil are important parts of our international business. We are accelerating the overseas development and launch of our products aiming to build a leading Chinese biopharmaceutical brand in global markets,” said Dou Changlin, PhD, president of research and development and chief operating officer of Boan Biotech, in a statement.