November 16, 2012 8:48 pm
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China is expected to issue its first set of regulatory standards for companies developing biosimilars, industry experts told this news service. The country is gradually moving its pharmaceutical regulations closer to international standards, with the aim to speed up drug registration, the experts added.
Biosimilars, or follow-on biologics, are drugs deemed to be similar to an originator biologic therapy. Biologic drugs are made in living organisms or their products, as opposed to traditional pharmaceutical drugs, which are made through chemical processes.
The China State Food and Drug Administration (SFDA) will release a new Drug Registration Regulation after the 18th National Congress of the Communist Party, said Haifeng Hu, vice president, Shanghai Institute of Pharmaceutical Industry. The 18th National Congress took place in Beijing 8-14 November.
Details of the biosimilars guidelines are currently undergoing investigation but will be finalized after the new drug registration regulation release, Hu noted.
In China, the healthcare reform and critical illness insurance program issued this year will bring growing demand for biologics, especially for oncology drugs. Monoclonal antibodies (mAbs) are expected to be at the forefront, said Jianhoung Tao, vice president, Southern Medicine Economic Research Institute (SMEI) of SFDA.
Domestic biosimilars have been on the market in China for 20 years, according to SMEI data. The first recombinant human interferon 1b was launched in 1989. Domestic EPOs, granulocyte-colony stimulating factors and mAbs are also commercialized in China. The country has approved 382 genetically engineered drugs and genetically engineered vaccines, but only 21 products are innovative and the rest are biosimilars, according to SMEI data.
The imperative to find cost-effective alternatives to biologics reflects the growing demand for these specialty drugs and provides opportunities for biosimilars, she added.
Biologics and biosimilars account for 10% of the total pharmaceuticals market in China, but their recent annual growth rate has reached 32.2%, according to Deloitte data.
Creating a framework
Under current regulations issued in 2007, biological products are classified into two categories - prevention or treatment - and there is no clear classification for biosimilars, said Hu. Qing Zhou, vice president, Genor Pharmaceutical, added under current regulations, biosimilars are classified under a new drug category.
The biosimilars guidelines will further improve regulations on technical requirements and the quality control of biologics to streamline the approval process, Tao added.
The guideline will be similar to US biosimilars guidelines, as SFDA has been working more closely with the US Food and Drug Administration (FDA), but the Chinese regulatory agency will also adapt its rules with reference to EU regulations, Hu noted.
Domestic enterprises welcome the introduction of biosimilars guidelines, which can reduce the cost and duration of clinical studies, said Guozhong Rui, director, China Pharmaceutical Technology Transfer Center. Current regulations state that companies are required to conduct Phase III trials for all biosimilars, he noted.
To issue a biosimilars guideline, the SFDA will encounter challenges, Zhou said, such as standardizing rules for assessing similarity and evaluating sophisticated technology and processes used in biologic development and manufacturing.
China’s current biosimilars regulations are unclear, so companies cannot conduct global multicenter trials for biosimilar products. The country only accepts global multicenter trials for chemical drugs, said Sally Sha, project director, Tigermed, a China-based contract research organization (CRO).
As a CRO, the first priority is to work with the government and pharma companies to improve the quality of clinical trials conducted in China in order to be accepted in developed countries, she added.
Chinese authorities are making strides to establish a completely separate drug approval system for innovative drugs and generics, said Beijing Labsolutions Pharmaceutical CEO John Gong. CDE is quite flexible to work with, and companies can negotiate with this division to accelerate the approval process, he said.
To increase the efficiency of drug approvals in China, CDE is preparing to set up subcenters in Beijing, Shanghai and Guangzhou with focused departments in each region, said Hu. The SFDA has also established initiatives to subcontract drug registration reviews, said Henry Sun, president, Tasly Pharmaceuticals, and vice president, Tasly Group.
This high-growth, emerging market is still developing, and the SFDA and the Center for Drug Evaluation (CDE) are determined to reach international standards, said Sha, but it will take some time for these changes to happen.
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