biosimilar (noun) - a substance of biological origin (such as a globulin, vaccine, or hormone) that is used in the prevention or treatment of disease and is highly similar to a previously-approved proprietary biologic
4 May 2017 - The World Health Organization (WHO) announced its plan to pilot a new project to prequalify biosimilars for cancer treatment. The move is expected to bring down the prices of the most expensive cancer treatments available, making them more accessible to low- and middle-income countries. If any biosimilars are approved through this program as being similar enough to originator products in terms of quality, safety, and efficacy, those biosimilars will be eligible for procurement by United Nations agencies around the world. "Biosimilars could be game changers for access to medicines for certain complex conditions," explained Dr. Suzanne Hill, WHO's director of Essential Medicines and Health Products. "But they need to be regulated appropriately to ensure therapeutic value and patient safety."
The decision was announced at a 2-day conference in Geneva about how to increase access to biotherapeutic medicines. In attendance were WHO officials, national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers. The WHO also announced its intention to begin prequalifying insulin. Read more here.
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