Quentin Horgan, senior analyst for GlobalData
The lack of an open and required interchangeable designation [in the European Union] means that the moment a biosimilar appears on the market it can be substituted for the reference biologic very easily.
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Analyst: China Leads APAC Region for Biosimilar Development, Marketing
Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are leading the wave of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.
China is behind the United States and European Union in terms of biosimilars approved and marketed, but it dominates the Asia-Pacific (APAC) region and potentially could eclipse US and EU rates of biosimilar adoption, according to Quentin Horgan, senior analyst with GlobalData, who presented on future biosimilar trends at CPhL North America.
China has at least 20 biosimilars on the market currently. The first one to gain approval was a rituximab biosimilar (HLX01; 2019) developed by Shanghai Henlius Biotech. “China saw a further 11 biosimilar approvals between 2019 and 2020, and 2 further approvals as of the first half of 2021,” Horgan said.
China’s positive environment for biosimilars was helped by changes at the country’s National Medical Products Administration, which released the first guidelines for biosimilar development in 2015, 10 years after the European Union, and removed barriers and lowered the cost of biosimilar research and development, Horgan said.
Regulatory policy is critical for biosimilar development and adoption, Horgan said. In the European Union, “The lack of an open and required interchangeable designation means that the moment a biosimilar appears on the market it can be substituted for the reference biologic very easily. This is very different from the United States, where the requirement of an [automatic] interchangeable designation limits the biosimilar’s uptake and makes it harder for pharmacies and payers to substitute.” He said this has caused payers to put biosimilars on lower, nonpreferred tiers.
Shanghai Henlius and Innovent Biologics are the leading biosimilar marketers in China currently, followed by Zhejiang Hisun Pharmaceutical, Sunshine Guojian Pharmaceutical Shanghai, and Qilu Pharmaceutical, he said.
The type of biosimilar products available in China reflect the therapeutic areas for which biosimilars have generally been approved globally, from oncology and immunology—at the top of the list—to musculoskeletal and hematological, toxicology, and, at the bottom of the list, ophthalmology.
Globally, antibodies are the major biosimilar type, representing a 53% share; followed by protein-based biosimilars, 32%; and peptides, 8%.
“The success of adalimumab biosimilars is driving antibody development,” Horgan said. “There are currently 68 adalimumab biosimilars marketed or in development.”
The APAC region accounts for 55% of biosimilar development, Horgan said. China, with a 41% share of APAC biosimilar development, is ahead of India (26%), South Korea (15%), Taiwan (8%), and Japan and Hong Kong (4% each). These figures give China and India a combined 77% share of the APAC market, Horgan said.
This dominance by APAC can be linked to the region’s traditional acceptance of generic drugs, which has made biosimilar uptake easier, he said. Biosimilar use also has been driven by “the need for cheaper pharmaceuticals within these less-economically-developed nations.”
Japan is not expected to become a strong, market-driven biosimilar developer because the Japanese harbor a “skepticism of unknown brands” of medicine, he said.
On a global scale, North America holds a 17% share of biosimilar development; and the European Union, 21%. South and Central America have 4%, and the Middle East and Africa, 3%, Horgan said.
Although the global biosimilar pipeline and sales are strong, Horgan said, in the context of other major pharmaceutical trends, biosimilars don’t rank very high. In a 2020 industry survey of emerging trends, they rated a 3.3 out of 5. Highest on the list were immuno-oncology drug development (3.9), personalized/precision medicine (3.9), remote patient monitoring (3.8), real-world evidence (3.8), and telemedicine (3.6).
The Center for Biosimilars recently interviewed Ping Cao, senior vice president of Business Development at Shanghai Henlius, about the company's development interests and market perspective. Pfizer, based in New York, was until recently a local player in the Chinese biosimilars market, but this year it withdrew from a substantial factory investment there. Awash in revenues from its success with the Pfizer-BioNTech COVID-19 vaccine, the company has taken a neutral stance on future biosimilar development.
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