Mammogram showing subtle cancer. Credit: Dr. Dwight Kaufman/National Cancer Institute.

Brazilian regulatory agency ANVISA has approved Biocon and Mylan’s biosimilar Trastuzumab through their partner Libbs Farmaceutica (Libbs).

Co-developed by the firms, Trastuzumab is indicated for over-expressing HER2-positive metastatic and early stage breast cancer, and HER2-positive advanced gastric cancer.

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The biosimilar is set to be commercialised in the country by Libbs under the brand name Zedora.

Biocon CEO and joint managing director Dr Arun Chandavarkar said: “This marks the first approval for a biosimilar Trastuzumab by Brazil’s ANVISA and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe.

“This marks the first approval for a biosimilar Trastuzumab by Brazil’s ANVISA and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe.”

“Cancer patients in India and some emerging markets have benefitted with our Trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for the treatment of HER2-positive breast and gastric cancers in the country.”

Biocon will manufacture and supply trastuzumab to Libbs for commercialisation, with plans to transfer the technology through a productive development partnership (PDP) to Libbs and the public partner Butantan.

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Libbs has completed the construction of a biotechnological site to manufacture Zedora for the Brazilian market.

Trastuzumab has already secured approval in various countries such as the US and India, and is under review by regulatory authorities in additional markets, including Australia, Canada and Europe.

While Mylan holds the commercialisation rights for the biosimilar in the US, Canada, Japan, Australia, New Zealand and select European countries, Biocon has co-exclusive rights with the firm in the remaining markets.