Gefitinib is a type of tyrosine kinase inhibitor [1], specifically an epidermal growth factor receptor (EGFR) inhibitor and is effective in cancers with mutated and overactive EGFR. These include some breast cancers and non-small cell lung cancer. In China, lung cancer is reported to be the leading cause of death, with approximately 591,000 people dying from the disease every year. In addition, it is reported that non-small cell lung cancer accounts for 80% of lung cancer cases.

The introduction of Yiruike to the Chinese market is reported to have brought an end to the monopoly occupied by Iressa since its introduction in 2005. Such monopolies drive up the cost of treatments and have been of concern to authorities in China. On 20 May 2016, China’s National Health and Family Planning Commission (NHFPC) announced a policy change and reported that agreements were made with certain pharmaceutical companies, including AstraZeneca, whereby the prices of expensive treatments were to be cut in exchange for bulk purchasing. As a result, it was reported that AstraZeneca was to lower the monthly cost for Iressa by more than half, from Yuan 15,000 (US$2,291) to Yuan 7,000 (US$1,069) [2].

The newly approved and introduced Yiruike is reported to have a price tag of just Yuan 2,000 (under US$300) per month, and thus vastly undercuts Iressa. It is claimed that this is likely to increase the availability of non-small cell lung cancer treatment for low-income Chinese citizens. It is also reported that a panel of Chinese pharmacists, headed by Professor Yang Guoping of Central South University, has also endorsed the generic drug treatment.

AstraZeneca’s Iressa patent expired in China in April 2016, which allowed for this competitor generic drug to be brought to market. It is reported that this is likely to further reduce global sales of Iressa that were down in 2016, relative to previous years, as a result of the policy changes in China. In India in 2012, it was reported that AstraZeneca unsuccessfully attempted to prevent sales reductions when they appealed the Iressa patent expiry [3].

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References
1. Eckstein N, Röper L, Haas B, Potthast H, Hermes U, Unkrig C.Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(2):79-87. doi:10.5639/gabij.2014.0302.021
2. GaBI Online - Generics and Biosimilars Initiative. China cuts prices for three drugs by more than 50% [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Generics/General/China-cuts-prices-for-three-drugs-by-more-than-50
3. GaBI Online - Generics and Biosimilars Initiative. India’s patent office at odds with Big Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Policies-Legislation/India-s-patent-office-at-odds-with-Big-Pharma

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