<p>Through Decree 63/2024, published on 22 January 2024, in the Official Gazette of the Argentine Republic, progress began on the regulation of the Decree of Need and Urgency (DNU). DNU 70/23 regarding articles related to the prescription of medications and their commercialization. Likewise, work is also being done on upcoming regulations.</p>
<p>ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.</p>
<p>WHO's most recent projections suggest a staggering 77% surge in new cancer cases globally by 2050, compared to the approximate 20 million recorded in 2022. As a result, the anticipated number of cancer-related deaths worldwide is poised to double to around 18.5 million by 2050, in contrast to the 9.7 million reported in 2022. Alarmingly, numerous countries still lack sufficient resources allocated to treatment and care services.</p>
<p>In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( <a name="_Hlk158533508" id="_Hlk158533508"></a>tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. </p>
<p><a href="https://gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab" target="_blank">Pertuzumab</a> is a monoclonal antibody (mAb) that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation. It is a pivotal therapeutic in oncology, targeting the overexpressed HER2 protein, particularly in breast cancer [1].</p>