<p>In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’&nbsp;Merilog&nbsp;(insulin aspart-szjj),&nbsp;referencing NovoNordisk’s NovoLog (insulin aspart); and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb), referencing Amgen’s Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination&nbsp;of interchangeability designation&nbsp;for both Ospomyv and Xbryk&nbsp;with its reference medicines.</p>

<p>In January 2025, the US’s Federal Trade Commission (FTC) published a second interim staff report examining the role of pharmacy benefit managers (PBMs) in the prescription drug industry, with a specific focus on specialty generic&nbsp;drugs.</p>

<p>The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson &amp; Johnson’s blockbuster drug for autoimmune diseases. With&nbsp;<b>eight biosimilars approved in Europe</b>&nbsp;and&nbsp;<b>seven in the US</b>, the competition is fierce, and the stakes are high.&nbsp;</p>

<p>Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in&nbsp;<i>GaBI Journal</i>&nbsp;titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria,&nbsp;Taiwan, and Turkey).</p>

<p>On 24 January 2025, the US Food and Drug Administration (FDA) has approved tocilizumab biosimilar, Avtozma&nbsp;(tocilizumab-anoh). Celltrion’s Avtozma (tocilizumab-anoh)/CT-P47 is a biosimilar referencing Roche/Genentech’s Actemra/RoActemra (tocilizumab).&nbsp;</p>

<p>On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring&nbsp;<b>December 16&nbsp;</b>as National Biosimilar Drug Day in Brazil. The law, published in the&nbsp;<i>Official Gazette of the Union</i>, aims to raise awareness about the importance of biosimilars in the healthcare system.</p>

<p>In January 2025, the&nbsp;US&nbsp;Food and Drug Administration&nbsp;(FDA) released a draft guidance titled ‘<i>Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products’ [1]</i>. This is the first guidance the agency has issued on the use of&nbsp;artificial intelligence (AI)&nbsp;for the development of drug and biological products.</p>

<p>On 30 January 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for for three biosimilar medicines: Dyrupeg (pegfilgrastim), Pavblu (aflibercept) and its duplicate Skojoy (aflibercept).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>seven biosimilars: Sandoz’s&nbsp;Afqlir, Formycon’s Ahzantive/Baiama, Accord Healthcare’s Absimky and Imuldosa, Samsung Bioepis’ Opuviz, Midas Pharma’s Ranibizumab Midas, and Prestige Biopharma’s Tuznue during September 2024 to January 2025.</p>

<p>Bio-Thera Solutions (Bio-Thera) has partnered with Tabuk Pharmaceutical Manufacturing (Tabuk) to exclusively manufacture, distribute, and market BAT2206, a biosimilar to Stelara (ustekinumab), in Saudi Arabia. Simultaneously, Bio-Thera expanded its collaboration with SteinCares, granting exclusive rights to distribute an additional biosimilar in Latin America, reinforcing its global biosimilar strategy.</p>