China Aims to Align with Global Naming Rules for Biologics, Biosimilars
China is working on an improved naming system for biologics and biosimilars to better ensure drug safety and good drug administration, according to national authorities. And the system would bring the country closer to internationally recognized naming rules.
“At the beginning, the industry, scientists and regulators didn’t realize the importance of naming biological products well,” said Zhongping Guo, division chief of biologics with the Chinese Pharmacopoeia Commission, at the 8th DIA China meeting in Beijing in May. “But with the rapid development of biopharmaceuticals, we started to face more challenges.”
Different countries have different naming systems for pharmaceuticals, but the World Health Organization (WHO)’s international nonproprietary names (INNs), known as generic names, are globally recognized.
The INNs facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients.
They also have the advantage of being universally recognized, systematically classified, brief and able to be distinguished by slight differences of the products from the same category.
The first INNs came out in 1953, and the WHO comes out with about a hundred new INNs every year. China didn’t use any INNs until 2010.
“There are not a lot of laws and regulations [in China] related to the naming of biological products – it only says briefly in the drug administrative law and the pharmacopoeia that marketed products should have generic names,” said Guo. “The registration of biosimilars may need separate consideration, but we’re looking for generality when it comes to the naming of all biological products.”
In most cases, the Chinese regulators adopt INNs for therapeutic biologics that have INNs registered with the WHO. But the names of preventive biologics, blood products and diagnostic products are usually the old-school ones.
“We have both structure descriptive names and INNs for biologics,” said Guo. “For products like vaccines and blood-based biologics, we use the traditional names that describe their structure.”
For products that already have INNs, they may also have a different name in China if they are domestically developed or made.
“For products that are already marketed in other countries under INNs, we use the INNs for them in China. But if they’re from local drugmakers, they may use their own names,” said Guo. “So even for therapeutic products that have INNs, they may still have different names in China, which is not good for drug administration.”
That’s why Chinese regulators have decided to amend the naming regulation for biological products in the country. The Chinese pharmacopoeia commission hopes the amendment will align the names of therapeutic biologics with those that the WHO uses and, at the same time, establish detailed naming principles for those products in Chinese.
“We are making changes for the sake of drug developers, but most importantly for better drug administration,” Guo pointed out.
What's in a Name?
Because of the complexity of biological products and the Chinese language itself, the Chinese naming of those products faces problems such as lacking intuitive literal understanding. For example, the Chinese name for filgrastim, a granulocyte colony-stimulating factor analogue, is “Fei Ge Si Ting.” “Fei” is a random prefix to express the different amino acid chains of the drug. “Si Ting” means it’s a type of colony-stimulating factor.
But the four Chinese characters would not make any sense to Chinese people when put together, except for maybe medical professionals.
Some of the upcoming challenges of naming biopharmaceuticals lie in the new structure of macromolecule recombinant proteins and structure-modified recombinant proteins.
Another issue is the naming of biosimilars. There has been a lot of discussion about whether biosimilars should use the same generic names as the originators, which would help them “blend in” better, or have their own brand names.
Peking University Cancer Hospital’s vice director of the Department of Lymphoma, Yuqin Song, noted that getting clinicians and patients to understand the names of the biosimilars is crucial because it would greatly lower the risk of drug misuse and help with pharmacovigilance for biosimilar products.
“Because of the structural and manufacturing complexity of biologics, it’s very hard to come up with an identical biosimilar product, and that poses risks for patients,” said Song. “Biosimilars also have problems of the difference in immunogenicity and limited drug safety data, so it’s very crucial to distinguish them from originators.”
As a clinician, Song said even though using different names for biosimilars would generate extra work for doctors to memorize more names, it’s worth it to ensure the safety of the patients.
“Surveys have shown that more than 77 percent of Chinese clinicians think drugs of [the] same generic names means they target [the] same indications, and more than 44 percent think the drugs are interchangeable,” said Song.
Song said regulators should take clinicians and patients, two end users of biosimilars, into account when developing naming regulations.
Brand names of the biosimilars should also appear on the prescription for parmacovigilance purposes. Drugmakers can put identification marks or explanation on the packaging of biosimilar products, like in the EU countries.
To read the original article, please click here
To learn more about key trends in the Biosimilars market and what it takes to succeed, view a complimentary presentation by Thomson Reuters IP&S and Amgen Inc.: “Driving Biosimilar Success: Insights From the Industry’s Leading Experts.”