Novartis (Switzerland) is facing generic competition against Glivec/Gleevec (imatinib mesylate) in China after local firms Chia Tai Tianqing Pharma and Jiangsu Hansoh Pharma gained approvals from the China Food and Drug Administration for alpha-crystalline versions of the drug as a treatment for chronic myelogenous leukaemia.
IHS Global Insight perspective
Chinese firms Jiangsu Chia Tai Tianqing Pharmaceutical Co. Ltd and Jiangsu Hansoh Pharmaceutical Co. Ltd have been granted manufacturing and marketing approvals for generic versions of Novartis (Switzerland)'s Glivec/Gleevec (imatinib mesylate) in China.
The approvals are for alpha-crystalline forms of the drug for the indication of chronic myelogenous leukaemia, meaning there are questions around the generics' efficacy; the beta-crystalline formulation remains patent protected until 2018, and the gastrointestinal stromal tumour indication is patent protected until 2021.
Novartis will face competition in a market that grew by 36% year-on-year in 2012 to CNY404 million (USD65.36 million), with the firm one of the first multinationals to employ a patient assistance programme in China to ease access to the drug without lowering its price.
Two generic versions of Novartis (Switzerland)'s Glivec/Gleevec (imatinib mesylate) have been approved by the China Food and Drug Administration (CFDA), Xinhua reports. China-based firms Jiangsu Chia Tai Tianqing Pharmaceutical Co. Ltd (CTTQ) and Jiangsu Hansoh Pharmaceutical Co. Ltd have received approval for their versions as treatment for chronic myelogenous leukaemia (CML). According to the source and a press release from CTTQ, the approvals are for the alpha-crystalline forms of the drug, which are not patent protected in China. CTTQ's approval is for the capsule form of the drug, while Jiangsu Hansoh received approval for a tablet version. For a link to CTTQ's press release (in Chinese), see here.
Outlook and implications
The approvals come two months after Novartis' patent for the alpha-crystalline version of imatinib lost protection in China; according to a report from PharmAsia News, the beta form of the drug remains patent protected until 2018, while the gastrointestinal stromal tumour indication is protected until 2021. CTTQ states that its alpha-crystalline version has proved comparable efficacy with Glivec. Chinese patients will hope that the generic versions are able to match Glivec's effectiveness as a treatment for CML; the tyrosine kinase inhibitor has transformed treatment of the condition with 85–90% 10-year survival rates.
Glivec's high price means that it is not included on the National Reimbursement Drug List, although the drug has been added to provincial Reimbursement Drugs Lists (RDLs) in three provinces, according to drug pricing website Yaozh.com. Novartis has maintained Glivec's price in China at levels comparable with other international markets, achieving prices of around CNY200 (USD32.35) per 100g pill in the most recent drug tenders in Chongqing city. This compares with around USD59.00 in the United States, according to IHS Global Insight calculations. Nevertheless, at more than CNY20,000 for a standard 120-tablet box, the drug has been beyond the reach of most patients.
Rather than dropping its price, the firm was among the first multinational companies to employ patient-assistance programmes (PAPs) in China. In provinces where the drug is reimbursed on the provincial RDL, patients pay for six months of treatment (reimbursed at around 70% by provincial authorities) and receive six months free from Novartis. In provinces where the drug is not RDL-listed, the PAP allows patients to pay for the full price out-of-pocket for three months of treatment, and then receive nine months free (source: China Charity Foundation). Novartis' PAP scheme in relation to Glivec was recently highlighted by outgoing health minister Chen Zhu as an example of the kind of flexible approach multinational firms should employ to make drugs accessible to the Chinese population, an approach he stated would avoid the issuance of compulsory licences and patent disputes seen in India, where Novartis in April threatened to cease research and development activities following the voiding of Glivec's patent (see China: 9 April 2013: China's outgoing health minister warns Big Pharma to negotiate on prices and India - Switzerland: 2 April 2013: Novartis will not invest in Indian-based R&D activities following Glivec ruling).
According to IMS figures, Glivec's China revenues reached CNY404 million (USD65.36 million) during 2012, growth of 36% year-on-year, thanks to the PAP scheme. It remains to be seen whether Novartis's market for Glivec in CML completely disappears, which will depend in large part on physicians' and patients' perceptions of the quality of the generic versions and whether they match the original's efficacy. Physicians and patients remain wary of the quality of locally produced drugs and tend towards foreign-made original brands when able to afford them.