<p>The European Medicines Agency (EMA) launched the European Shortages Monitoring Platform (ESMP) to address persistent medicine shortages across the&nbsp;European Union (EU).&nbsp;This centralized system improves reporting, monitoring, and management, ensuring medicine availability during crises and public health emergencies,&nbsp;and will be mandatory from 2025.</p>

<p>On 11 October 2024, Health Canada approved Fresenius Kabi’s tocilizumab biosimilar, Tyenne&nbsp;–&nbsp;the first&nbsp;and only tocilizumab biosimilar&nbsp;currently available&nbsp;in&nbsp;Canada&nbsp;– which&nbsp;references Roche’s Actemra/RoActemra (tocilizumab).</p>

<p>Shanghai Henlius Biotech and Organon announced on 30 September 2024 that their phase 3 comparative clinical trial for HLX11, an investigational biosimilar to Perjeta (pertuzumab), met its primary endpoint.&nbsp;</p>

<p>Alvotech and STADA’s Uzpruvo/AVT04 is an ustekinumab biosimilar with similar efficacy, tolerability, safety and physicochemical and biological characteristics to Stelara, the reference product, as has been summarized in a recent study published in&nbsp;<i>Clinical Drug Investigation</i>&nbsp;[1].</p>

<p>On 17 October 2024, the&nbsp;European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization&nbsp;for Accord’s Absimky and Imuldosa, both of which are ustekinumab biosimilars referencing Janssen/Johnson &amp; Johnson’s Stelara.</p>

<p>The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis, in Canada.</p>

<p>In recent years, biosimilar medicines have gained increased support and access in Australia through the Pharmaceutical Benefits Scheme (PBS), a government program designed to subsidizes essential medicines and make them affordable for all Australians. Biosimilars are versions of original biological medicines that are highly similar in terms of quality, safety, and efficacy but are generally more affordable.</p>

<p>India-based&nbsp;Lupin&nbsp;Limited (Lupin) announced on 23 August 2024 that it received&nbsp;marketing&nbsp;approval from Health Canada for its biosimilar pegfilgrastim biosimilar, which will be marketed as Armlupeg.</p>

<p>On 31&nbsp;October 2024, it was announced that&nbsp;Chicago-based&nbsp;Meitheal Pharmaceuticals had expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry&nbsp;Co, to&nbsp;market and distribute three biosimilars in the US. These&nbsp;include the&nbsp;oncology biosimilars pegfilgrastim and filgrastim,&nbsp;as well as&nbsp;fertility treatment follitropin alpha.&nbsp;</p>

<p> <b>23rd&nbsp;</b><b>3rd Bioequivalence&nbsp;Conference 2025</b><br /> <b>26 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>