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FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
<p>On 9 October 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron’s Eylea (<a ...
ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept
<p>In September 2025, ANVISA, the Brazilian Health Regulatory Agency, issued favourable opinions recommending marketing authorization for four biosimilars, including two ...
New direction for health regulation in Mexico
<p>Mexico's health regulator, Federal Commission for the Protection against Sanitary Risks (<i>Comisión Federal para la Protección contra Riesgos ...
EU steps closer to the ‘tailored approach’ for biosimilars development
<p>In September 2025, the European Medicines Agency’s (EMA) Biosimilar Medicinal Products Working Party (BMWP) held a ‘Workshop on a tailored clinical approach in biosimilar ...
China’s ‘health silk road’ progress in Africa
<p>In October 2025, it was announced that China is advancing its ‘health silk road’ in Africa by initiating the local production of essential medicines such as insulin, ...
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