<p>On 3 April 2024,&nbsp;China-based biopharmaceutical company&nbsp;Mabwell announced that their Maiweijian (denosumab) injection, developed by its&nbsp;wholly owned&nbsp;subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab&nbsp;copy biologicalto receive marketing approval in China.</p>

<p>In an article by Dr Joshua Cohen, he&nbsp;discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologics like Humira.&nbsp;</p>

<p>In&nbsp;February 2024, Polpharma Biologics&nbsp;(Polpharma)&nbsp;unveiled topline results demonstrating the PK and pharmacodynamic (PD) comparability&nbsp;of PB016, their biosimilar candidate for&nbsp;vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.</p>

<p>On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.&nbsp;</p>

<p>In February 2024, Mexico’s COFEPRIS (<i>Comisión Federal para la Protección contra Riesgos Sanitarios</i>) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.</p>

<p>mAbxience announced in February 2024&nbsp;a pivotal agreement with Biosidus to manufacture Agalsidase Beta. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease.</p>

<p>The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.</p>

<p>Biosimilar products, vital for widening access to essential treatments and reducing healthcare costs, face varied uptake influenced by factors like pricing and healthcare settings. Kozlowski et al.'s study compares adoption rates in Medicare Advantage (MA) and Traditional Medicare (TM), revealing significant differences [1].</p>

<p>According to a review by&nbsp;Machado&nbsp;et al.,&nbsp;across seven Latin American nations, biosimilar approval patterns diverge from Canada, Europe, and the US. Anti-anaemic and diabetes treatments are notably lacking approvals, while Brazil emerges as a leader in biosimilar authorization [1].</p>

<p>A&nbsp;GaBIJ&nbsp;perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of authors from Biocon Biologics in August 2023 [1].</p>