China’s National Medical Products Administration (NMPA) says it has approved the country’s very first biosimilar, a copy of Roche’s lymphoma drug Rituxan made by Fosun Pharma’s joint venture subsidiary Shanghai Henlius Biotech. Rituxan just so happens to be the first monoclonal antibody the FDA ever approved for cancer.
The approval will no doubt put Roche under pressure, as the NMPA has said getting biosimilars on the market would help increase biologic drugs’ accessibility and drive down costs.
Roche has already been preparing for this day. Back in 2017, the Swiss drugmaker took a 45% discount on the 100-mg/10-ml Rituxan vial and 58% for the 500-mg/50-ml vial to win a spot on the country’s National Reimbursement Drug List and hence secure a solid market share before biosimilar assault.
In 2017, Rituxan amassed about 1.73 billion yuan ($258.6 million) in China sales, Fosun Pharma said in a disclosure (PDF, Chinese), citing Iqvia data.
The Chinese green light came about three months after the FDA blessed Celltrion and Teva’s Truxima, the first Rituxan biosim for the U.S. market. In Europe, where copycats have already landed, sales of the Roche originator dropped 46% in the fourth quarter, to CHF 185 million, as knockoffs have taken about half the drug’s market share, Bernstein analyst Ronny Gal previously noted.
At 2018’s Chinese Society of Clinical Oncology annual meeting, Henlius showed that the drug, previously known as HLX01, could match up to Rituxan in patients with CD20-positive non-Hodgkin lymphoma in terms of overall response rate. The Chinese drug regulators put it under priority review to expedite its evaluation.
Henlius is also going after the other two Roche cancer top sellers—Herceptin and Avastin—with a copycat to each already in phase 3 studies. In addition, it has licensed a Kadcyla biosim from LegoChem Biosciences for HER2-positive breast cancer, and it has a copycat to AbbVie’s Humira in late-stage development.
Fosun, which holds about 60% of Henlius’ shares, is currently in the process of spinning the biologics specialist off into a standalone firm listed on the Hong Kong Stock Exchange under the recently tweaked listing rules that open the door to prerevenue biotechs. But Fosun Pharma will help with commercialization of the Rituxan and Humira copycats.
“Fosun Pharma’s extensive sales network and superior market access expertise will greatly facilitate our strategy to quickly seize first-entrant advantages,” Henlius said in its prospectus (PDF) to HKEX in December.
According to NMPA, China currently ranks as the country with the most biosimilars in development, with over 200 biosimilars cleared for clinical trials.
Frontpage September 8, 2018