Tony Hagen is senior managing editor for The Center for Biosimilars®.
China is getting the hang of producing biosimilars, and harvest time is on the near horizon, according to a new report.
China has lagged in the adoption of anticancer biosimilars, but a huge number of agents in development suggest an “incoming wave” of these agents is about to hit, according to authors of a recent study.
Just 2 anticancer biosimilars were approved in China by the end of 2019, but the country has 23.9% of the global cancer burden. The turning point in China could occur very soon, the authors said, noting that 54 anticancer biosimilars representing 7 reference products are under clinical development in mainland China, 3 are involved in new drug application reviews, and 27 are in late-phase efficacy comparative studies.
These findings were included in a report of biosimilar adoption in 40 countries with 78.1% of the worldwide cancer incidence.
China’s biosimilar development engine is supercharged and running on octane, the report said.
“Indeed [in China], the number of trials of anticancer biosimilars initiated between 2016 and 2019 was 11 times higher than the number initiated between 2012 and 2015,” the authors wrote.
Developers May Be Overdoing It
The report said manufacturers may be tripping over one another in the development of anticancer biosimilars in China, because there are dozens of biosimilars under development for just 5 reference anticancer products: bevacizumab (n = 17); rituximab, 13; trastuzumab, 10; cetuximab, 6; and denosumab, 4.
“To ensure coordinated effort, the government should guide pharmaceutical companies to set rational priorities for drug research and development,” the authors wrote.
In emerging biosimilar markets, there is a need for payers to develop “rational” payment plans for anticancer biosimilars, but China, has “effectively” addressed the affordability issue by using large-scale, competitive procurement bidding for drugs, the authors wrote.
They said this means of settling the affordability issue could lead to problems of not enough supply.
“Globally, we should be aware of the potential danger of adopting price competition alone as a way to attain affordability; prices must be balanced, because setting them too low could drive manufacturers out of business, leading to possible shortages of cancer drugs.”
They also said market behavior needs to be eased into a legislative framework that protects against abuses.
“Anti-competitive business practices, such as the introduction of pseudo-generics, collusion, and delaying the entry of a generic or biosimilar, should not be encouraged, as these might hamper sustainable biosimilar markets and consistent delivery of the best health care for patients. Manufacturers should also not, for the sake of affordability, yield to pressure to lower standards.”
Half of Biosimilars Globally Are Anticancer
In the 40 countries studied by investigators, 262 biosimilars in all had been approved by the end of 2019. Half of those agents were oncology biosimilars, including 63 (24%) anticancer agents and 66 (25%) cancer supportive agents.
In that total, there were 20 biosimilars for rituximab; 14 for trastuzumab; and 14, bevacizumab. These 3 anticancer agents were the most common internationally. In all, they referenced 10 originator anticancer products.
“The popularity of generating biosimilars for these 3 biological drugs is closely associated with the timing of patent expiration and likely driven by commercial interest, as these were the top 3 biological drugs for cancer by retail sale in 2018, globally,” the investigators said.
Among the 6 continents compassed in the study, Asia had the largest number of approved anticancer biosimilars (n = 33) representing 9 separate reference products; Africa had 3 approved biosimilars; and Oceana, representing Australia, New Zealand and thousands of islands, had 6. North America had 10 anticancer biosimilars at the end of 2019; and Europe, 18, according to the study.
Authors said that the availability of biosimilars in each continent was roughly equivalent to the incidence of cancer in these zones.
The authors found a strong, positive correlation between income level and biosimilar availability on the international level (correlation coefficient [CC] 0.534; P = .005). A CC of 0.0 shows no relationship, and a CC of 1.0 would represent a perfect positive correlation.
“Healthcare systems in high-income countries have incentives to adopt lower cost biosimilars, and governments are willing to accelerate their approval and promote their adoption through insurance coverage,” the authors hypothesized, in an effort to explain why this relationship between income and drug availability exists.
By contrast, in countries where healthcare budgets are not as robust, pharmaceutical companies have less incentive to introduce biosimilar products, the authors said. Another reason might be that lower-income countries may have less-developed intellectual capital protection laws and regulatory frameworks, they said.
“Issues such as manufacturing processes, quality control, storage, and regulatory enforcement must be properly addressed to avoid production of substandard oncology generics or biosimilars,” they added.
Huang H-Y, Wu D-W, Ma F, et al. Availability of anticancer biosimilars in 40 countries. Lancet. 2020;21(2)197-201. doi: 10.1016/S1470-2045(19)30860-5.