<p>On&nbsp;23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar&nbsp;as the first subcutaneous (SC) formulation of&nbsp;infliximab. In addition,&nbsp;Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.</p>

<p>A review by Rusiñol et al. emphasized the significant impact of biologicals on psoriasis management. Anti-IL-17 and anti-IL-23 biologicals are regarded as highly effective and long-lasting treatments in real-world scenarios, with IL-23-targeting biologicals showing the best safety profile and potential to modify the natural course of psoriasis.</p>

<p>In a review by&nbsp;Machado et.al., the authors examine the transparency and guidelines for biosimilars licensing and the number of biosimilars approved by 13 medicines regulatory authorities.&nbsp;In this context, we focused the discussion on seven Latin American countries:&nbsp;Argentina, Brazil, Chile, Colombia, Guatemala, Mexico and Peru&nbsp;as part of the broader review [1].</p>

<p>Biologics are the fastest-growing class of medications in the United States and account for a substantial and growing portion of health care costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the U.S. Food and Drug Administration (FDA) to help provide patients with greater access to safe and effective biological products. As of&nbsp;1 November 2023, FDA has approved 44 biosimilar products, 7 of which are interchangeable biosimilars. These products can be used to treat many conditions such as chronic skin and bowel diseases, arthritis, kidney conditions, diabetes, multiple sclerosis, macular degeneration, and cancer.</p>

<p>In September 2023, the European&nbsp;Commission (EC) approved&nbsp;the&nbsp;biosimilars&nbsp;Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).</p>

<p>Ocrelizumab is a therapeutic monoclonal antibody (mAb) that represents a different scientific approach to treating&nbsp;multiple sclerosis (MS).&nbsp;It is a humanized anti-CD20 mAb that targets CD20 marker on B lymphocytes, a typo of immune cell that plays a key role in the disease and serves as an immunosuppressive drug. Ocrelizumab binds selectively&nbsp;to&nbsp;CD20, which is expressed on the membrane of&nbsp;B cells. When ocrelizumab binds to CD20 on B cells, these cells are eliminated by&nbsp;antibody-dependent cell-mediated cytotoxicity&nbsp;and, to a lesser extent,&nbsp;complement-dependent cytotoxicity.</p>

<p>On 6 November 2023, the U.S. Centers for Medicare &amp; Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).</p>

<p>In a dynamic landscape of pharmaceutical developments, Biocon Biologics&nbsp;(Biocon)&nbsp;faces a regulatory hurdle with a complete response letter from the&nbsp;US&nbsp;Food and Drug Administration (FDA), while Meitheal Pharmaceuticals expands its reach through a strategic licensing agreement with Tonghua Dongbao Pharmaceutical.</p>

<p>According to&nbsp;a study led by Bas (2023),&nbsp;the Latin American (LA) biosimilars market is positioned for substantial growth over the next decades&nbsp;as a cost-effective alternative to expensive patented biomolecules&nbsp;[1].</p>

<p>On 9 November<b>&nbsp;</b>2023,&nbsp;the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.</p>