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Mylan-Biocon’s breast cancer biosimilar gets ANVISA nod

NEW DELHI: Drug major Biocon and Mylan’s proposed biosimilar trastuzumab has been approved by Brazilian regulatory agency ANVISA, through their partner Libbs Farmaceutica (Libbs).

Biosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan.

In a regulatory filing, Biocon said this is the first biosimilar trastuzumab to be approved in Brazil.
Commenting on the development, Biocon CEO and Joint Managing Director Arun Chandavarkar said: “Cancer patients in India and some emerging markets have benefited with our trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for treatment of HER-2 positive breast and gastric cancer in the country”.

Biocon said currently biosimilar trastuzumab will be manufactured by it and supplied to Libbs for commercialisation in Brazil.

“Over a period of time the technology will be transferred to Libbs and the public partner Butantan through a productive development partnership (PDP).

Earlier this month, the US health regulator approved biosimilar trastuzumab. The proposed biosimilar is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.

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