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Generic version of AZ’s Iressa launched in China

Qilu Pharma’s Yiruike licensed as first-line NSCLC treatment
AZ

AstraZeneca's lung cancer therapy Iressa (gefitinib) is facing generic competition in China, after Qilu Pharmaceutical's Yiruike won marketing authorisation earlier this week.

Generics specialist Qilu is the first to launch a copycat version of AstraZeneca's EGFR inhibitor in China, with the firm losing patent protection for Iressa in the market in April last year.

The new generic, Yiruike, has been licensed by the Chinese regulatory authorities as a first-line therapy for patients with non-small cell lung cancer (NSCLC) who have the EGFR-TK mutation.

It will go on the market at less than 2,000 yuan - approximately £234 - per pack, according to Qilu's general manager Li Yan, further reducing the price of access to gefitinib after last year saw the Chinese health authorities cut Iressa's monthly cost from 15,000 yuan to 7,000 yuan.

Iressa was first approved in the US in 2003, but taken off the market by AstraZeneca in 2011 after it failed to improve overall survival in a placebo-controlled trial.

However, the cancer treatment returned to market in 2015 after winning FDA approval once more in first-line NSCLC therapy thanks to Qiagen's companion diagnostic blood test, which is used to select patients most likely to respond to Iressa based on a tumour tissue sample.

 AstraZenecas still retains patent protection for Iressa in many territories, including the US, but is also facing competition from newer NSCLC therapies including the firm's own Tagrisso (osimertinib).

There are around 733,000 new cases of lung cancer in China every year with NSCLC accounting for 80% of diagnoses, according to its national cancer centre, and around 591,000 people die from the disease annually. 

Article by
Rebecca Clifford

21st February 2017

From: Regulatory

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