First Ever Biosimilar Approval in China: Trouble for Roche?

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China’s regulator approved a biosimilar version of Roche’s Rituxan this week, the first such drug ever to be given the green light in the country. With numerous other biological copycats of blockbuster drugs in development, potentially difficult times lie ahead for Roche and other Big Pharma firms in China.

 

The biosimilar drug – a copy of Roche’s lymphoma treatment Rituxan – was granted approval by China’s National Medical Products Administration (NMPA) on Monday (25th February). Manufactured by Shanghai Henlius Biotech, a joint venture subsidiary of domestic heavyweight Fosun Pharma, the drug represents the first ever biosimilar approved in China. Given that the east Asian nation is the country with the most biosimilars in development globally, this could herald the beginning of a wave of approvals. According to NPMA statistics, over 200 biosimilar medicines are currently cleared for clinical trials in China.

 

This approval may spell trouble for Roche, which performed well globally in 2018 despite biosimilar competition. Sales of their originator drug dropped by 46 percent in Europe after the launch of biosimilars for Rituxan, taking around half of Roche’s market share there. However, the company has been preparing for this inevitability in China, taking a 45 percent discount on the 100-mg/10-ml Rituxan vial and a 58 percent discount for the 500-mg/50-ml vial in 2017 to gain a place on China’s National Reimbursement Drug List and thereby secure a solid market share prior to the launch of biosimilars.

 

Fosun Pharma’s extensive sales network and superior market access expertise will greatly facilitate our strategy to quickly seize first-entrant advantages

Henlius prospectus to HKEX

Further blows to the Swiss giant seem set to come, as Henlius already has biosimilars to Roche’s other two cancer top sellers – Herceptin and Avastin – in Phase III studies. It has also licensed a Kadcyla biosim from LegoChem Biosciences for HER2-positive breast cancer and has a biosimilar to AbbVie’s Humira in late-stage development.

 

Although Henlius is currently in the process of being spun off into a standalone firm listed on the Hong Kong stock exchange (HKEX), it will still be able to draw on the expertise and capacity of Fosun – which holds around 60 percent of Henlius’ shares – to commercialize these new products. In its prospectus to HKEX in December, Helius stated that “Fosun Pharma’s extensive sales network and superior market access expertise will greatly facilitate our strategy to quickly seize first-entrant advantages.”

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