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Iraqi regulatory authority current system and experience with biosimilars
Khalid K Al-Kinani1, Mazin J Ibrahim2, Ruaa F Al-Zubaidi3
1College of Pharmacy, University of Baghdad, Baghdad, Iraq.
Regulatory Toxicology and Pharmacology : RTP
|August 31, 2020
Summary
Iraq
Area of Science:
- Pharmaceutical Policy
- Health Economics
- Drug Regulation
Background:
- Biological medicines offer advanced treatments for chronic conditions like cancer and diabetes.
- High costs of biologicals limit patient access globally and in Iraq.
- Biosimilars present a strategy to enhance access to biological therapies.
Purpose of the Study:
- To evaluate the impact of new Iraqi biosimilar guidelines on medicine accessibility and cost savings.
- To identify challenges and propose strategies for maximizing biosimilar benefits in Iraq.
Main Methods:
- Analysis of the Iraqi National Regulatory Authority's (NRA) policy changes regarding biosimilar approvals.
- Assessment of cost savings and product approvals following guideline implementation.
- Identification of barriers to biosimilar uptake among healthcare providers.
Main Results:
- Implementation of Iraqi biosimilar guidelines led to the approval of essential products.
- Significant cost savings exceeding $50 million USD were achieved in 2020.
- Lack of familiarity among healthcare providers remains a key barrier.
Conclusions:
- Iraq's regulatory reforms have successfully increased access to affordable biological medicines through biosimilars.
- Targeted awareness strategies are crucial for healthcare providers to fully leverage biosimilar benefits.
- Continued regulatory efforts can further optimize biosimilar utilization for public health gains.
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