Once the efficiency of expenditure in the health sector is increased, healthcare services improve in any given country. Introducing generic and biosimilar medicines into the national formulary (NF) in order to provide safe, effective and more affordable treatments for patients decreases the financial burden for both patients and the government. By reducing the amount of money spent on originator biologicals, the Ministry of Health (MOH) can allocate a larger part of its healthcare budget to increasing access to medicines and practices such as building hospitals or providing more high-tech health products and services.

Prior to 2016, the MOH of Iraq was relying mainly on brand-name originator biologicals in its hospitals. However, in 2016, the healthcare budget planning team at the Ministry decided to change this approach. The team observed that by introducing off-patentbiologicals, the price of originator biologicals decreased due to the emerging competition in the market.

Since off-patentbiologicals have a similar safety and efficacy profile as the reference medicinal product (RMP) but with a lower price, dedicating a larger part of the budget to off-patent biologicals has helped the government to make healthcare budget savings. Records show that the MOH of Iraq will be able to save over US$100 million in one tender in 2018 [3-8], by purchasing off-patent biologicals from Iranian biopharmaceutical company CinnaGen, one of the biggest biotech enterprises in the Middle East and North Africa (MENA) region.

In fact, the first off-patent biological monoclonal antibodies were introduced into the Iraqi market  by Aryogen Pharmed, a member of the CinnaGen pharmaceutical group, which included Zytux (off-patent biologicals to MabThera (rituximab)] and AryoTrust [off-patent biologicals to Herceptin (trastuzumab) [9, 10].

For the 2016-2017 tender contracts, by dedicating only 25% of the biologicals market share to CinnaGen’s products, Iraq’s MOH saved US$17 million [9-13]. This would have reached US$66 million [[9-13] if all of the biologicals available in Iraq were switched to off-patent biologicals in these tenders, according to CinnaGen.

European healthcare systems have been pioneers in making biosimilars accessible to more patients. Now more and more countries outside of Europe are catching on. Iraq is one of the many countries that is incorporating off-patent biologicals into its healthcare system to increase access to high quality medicinal products for patients.

Related article
MENA region biologicals maker CinnaGen receives EU GMP certification

Biosimilars of rituximab

Biosimilars of trastuzumab

References
1. Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol.. 2014;41(3):S13-20.
2. Blackstone EA, Fuhr JP. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-78.
3. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Inv .MED 1/2018 the closing date 28/1/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7726
4. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Inv .MED --2 --2018 the closing date 18/3/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7806
5. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Inv .MED 5/2018 the closing date 1/7/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/8019
6. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Med 1/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7812
7. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Med 3/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7873
8. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Med 5/2018 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/8168
9. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Drug assignments table (4) for 2016 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7038
10. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Drug assignments table (7) for 2014 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/5974
11. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Drug assignments table (1) for 2017 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7374
12. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Drug awarding table (3) for 2017 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7489
13. Republic of Iraq. Ministry Of Health/Environment. The State Co. for Marketing Drugs and Medical Appliances. Drug Awarding Table (4) for 2017 [homepage on the Internet]. [cited 2018 Dec 14]. Available from: http://kimadia.iq/en/article/detail/7620

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