Biosimilar Boom in China Heralded By First Approval
Executive Summary
Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home.
China’s National Medical Products Administration (NMPA) on Feb. 22 announced the approval of Shanghai Henlius Biotech Co. Ltd’s HLX-01, a biosimilar to Roche’s MabThera (rituximab), for non-Hodgkin’s lymphoma, making it the first biosimilar to be approved under the country’s regulatory pathway for such follow-on biologics.
The product was granted a priority review by the NMPA and is also designated as a National Major Technical Breakthrough Breakthrough project.
MabThera is the third-largest selling anticancer product for Roche globally after Avastin (bevacizumab) and Herceptin (trastuzumab). But facing increasing regional competition from biosimilars, MabThera's 2018 sales declined by roughly 50% in Europe, noted the Swiss company in its January earnings report. In China, sales of the original product grew by 11% in the year, driven by expansion in reimbursement and access.
Henlius is at the forefront of biosimilar development in China, where biologics are expected to grow rapidly, driven by policy changes such as reimbursement expansion and pricing negotiations. With a large pipeline consisting of anticancer and rheumatoid arthritis biosimilars, the Shanghai-based firm, backed by Fosun International Ltd., is the largest biotech unicorn in China, with a current market valuation of $2.95bn.
The market name of HLX-01 will be Hanlikang, noted the company. A spokesperson told the Pink Sheet that pricing and a launch date had not been decided yet.
Policy Changes
Previously, biosimilars such as 3SBio Inc.’s Yisaipu, a version of Pfizer Inc./Amgen Inc.’s Enbrel (etanercept), had to be reviewed in China under the pathway for new biologics. But in 2015, the then China FDA issued specific guidelines for biosimilar products, opening the floodgates to development activities in the country.
Entering 2019, the Chinese government is stepping up its bid to quicken generic products approvals in general, to expand use amid rising healthcare costs.
The State Council in January issued a decree encouraging generic production and supply, in which the government said it would compile and issue a catalog listing generics drugs that will be given priority reviews. The aim is to support the underlining technologies to develop both chemical and biologic generics.
Regulatory reviews and approvals of generics will also be accelerated, via priority reviews and fast-track treatment of the listed generics.
Development Boom
China now has the highest number of biosimiliars in development in the world, with 200 in various stages, and as many as five other products are either awaiting a green light or in late-stage Phase III development.
These include Guangzhou-based Bio-Thera Solutions' BAT1406, a biosimilar to AbbVie Inc.s Humira (adalimumab), which has been accepted for review by the NMPA. Meanwhile, Suzhou-based Innovent Biologics Inc. has two biosimilars pending review, IBI303 (adalimumab) and IBI-305 (bevacizumab).
Two more from Henlius, HLX02 (trastuzumab) and HLX03 (adalimumab), are currently in Phase III. (Also see "Better Together: New Deal Adds Weight To China Biosimilar/Biobetter Swap" - Scrip, 7 Nov, 2018.)
Similar to the immuno-oncology sector, where China has approved four agents – two each from multinationals and domestic developers – the biosimilar field could see more approvals from both domestic and international firms.
The more favorable policy environment and potential for rapid growth has already led to several high-profile collaborations, including between Korean and Chinese firms to commercialize products in China. (Also see "China - The Next Promised Land For Korean Biosimilars?" - Scrip, 12 Feb, 2019.)
However, there are signs that investment into biosimilar development in China may be shrinking recently, given the spotlight on the red-hot IO and cell therapy sectors, including CAR-T therapies, which had many wondering if this was at the expense of biosimilars. Now with the new approval, biosimilars seem to be stepping back front and center.
'Affordable Innovation' Going Global
A remaining obstacle for originator biologics that may potentially open opportunities for biosimilars in China is cost. Even the use of some global best-selling anticancer biologics in China has been limited, in the range of 5-10% of their market. Making biologic therapy more accessible is thus vital for biosimilars' commercial success in the country, prompting Henlius' mantra of "affordable innovation."In a September sit-down interview, Henlius CEO Scott Liu pointed to several ways to achieve this goal, including the opening of two production lines to accommodate multiple products, use of cell strains with high-expression, and in-house developed cell culturing methods.
Another Henlius strategy to keep costs low is to combine biosimilars with its innovative biologics such as an IO agent, thus expanding the indications to more cancer types. The company is also actively pursuing biosimilars markets outside China, where demand is high and patients price-sensitive.
Henlius has already signed two separate licensing deals to market HX-02 (biosimilar trastuzumab) in ASEAN, Eastern European and Middle East North Africa countries, and out of all emerging markets, it has identified total 16 high-priority countries including Ukraine, Poland and The Philippines.
From the editors of PharmAsia News.