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Mylan and Biocon biosimilar approval expands to Brazil

Published on 02/01/18 at 10:03am

Since Mylan and Biocon managed to gain US FDA approval for its Herceptin (Trastuzumab) biosimilar, it has forged ahead in the global market to make up for time lost due to manufacturing issues. It has now announced that its product, Ogrivi, will be made available in the Brazilian market.

The partnership between Mylan and Biocon on the biosimilar goes back a decade but had become problematic after Biocon’s Bangalore, India, based facility had failed to pass FDA inspections.

However, at the end of 2017, the FDA finally announced that the manufacturing facility had passed in section and gave the green light for the product to be launched.

Herceptin reaped owner Roche $7 billion in worldwide sales in 2016 and Mylan-Biocon will be hoping to snag a fair portion of that market for itself.

Included in the announcement of the approval was the fact that the biosimilar would become the first Herceptin biosimilar approved in Brazil, after its Agência Nacional de Vigilância Sanitária (ANVISA) accepted the drug’s sale within the market.

Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, 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. 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 the treatment of HER2-positive breast and gastric cancers in the country. We are committed to make global impact with our affordable antibodies against cancer.”

There are other Herceptin biosimilars on the global market, after Samsung Bioepis managed to get its product, Ontruzant, approved by European regulators – making it the first to break into this large market.

 Biosimilars entry onto the market has sparked something of an arms race, on both the originator product and the biosimilar competitors’ side of the market. Early biosimilar approval can lead to higher sales, however, the US market has seen originator companies fighting back to delay adoption – leading to legal spats and struggling sales.

Ben Hargreaves

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