News & Events.

11 Mar.

<p>On 23 February 2024, the&nbsp;US&nbsp;Food and Drug Administration&nbsp;(FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).</p>

11 Mar.

<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&nbsp;70/23 regarding articles related to the prescription of medications and their commercialization. Likewise, work is also being done on upcoming regulations.</p>

11 Mar.

<p>ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition,&nbsp;identification of medicinal products&nbsp;(IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.</p>

07 Mar.

<p>A study by Meijboom et al. aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar [1].</p>

07 Mar.

<p>The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.</p>

07 Mar.

<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>

29 Feb.

<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&nbsp;FDA&nbsp;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.&nbsp;</p>

29 Feb.

<p><a href="https://gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab" target="_blank">Pertuzumab</a>&nbsp;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&nbsp;a pivotal therapeutic in oncology, targeting the overexpressed HER2 protein, particularly in breast cancer [1].</p>

29 Feb.

<p>On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.</p>

09 Feb.

<p>In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'.&nbsp;</p>

Copyright © 2024 Darou Darman Arang Co. All rights reserved.