<p>In June 2024, the US Food and Drug Administration (FDA) issued a draft guidance for industry ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’ [1]. This draft guidance outlines considerations for switching studies to demonstrate a biological product's interchangeability with a reference product.</p>

<p>In April and June 2024, Icelandic biosimilar company Alvotech announced promising results from two clinical studies (AVT05-GL-P01, NCT05632211; AVT05-GL-C01, NCT05842213) for AVT05, their candidate golimumab biosimilar. Alvotech is the first company to announce topline results of clinical trials using a proposed biosimilar to Simponi (Janssen Biotech).</p>

<p>On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson &amp; Johnson’s (J&amp;J) Stelera.</p>

<p>On 27 June 2024, Coherus BioSciences announced that is has divested Yusimry (aflibercept-jbvf). an adalimumab biosimilar to AbbVie’s rheumatoid arthritis therapy Humira, to Hong Kong King-Friend Industrial (HKF) in a US$40m deal.</p>

<p>On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.</p>

<p>In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.</p>

<p>Panama is implementing internationally standardized reporting codes for pharmacovigilance by adopting WHODrug Global and MedDRA dictionaries, following the example of several other Latin American and Caribbean countries.</p>

<p>The European Commission (EC) granted marketing authorization for four biosimilars. They are Celltrion’s Omlyclo (omalizumab),&nbsp;Sandoz’s denosumab biosimilars Jubbonti and Wyost,&nbsp;and Samsung Bioepis’&nbsp;Pyzchiva (ustekinumab).&nbsp;Furthermore, the EC approves expanded indication for&nbsp;Samsung Bioepis' Epysqli (eculizumab) to include treatment of atypical haemolytic uremic syndrome (aHUS).</p>

<p>In June 2024, Celltrion announced promising results&nbsp;from&nbsp;their phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab),&nbsp;in patients with rheumatoid arthritis (RA).&nbsp;Additionally, the company&nbsp;has submitted an investigational new drug (IND) application to the&nbsp;US&nbsp;Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar.&nbsp;This announcement follows&nbsp;the news that in April&nbsp;2024, rival Korean biologicals company Samsung Bioepis initiated a phase III clinical trial for SB27, their pembrolizumab biosimilar.</p>

<p>On 13&nbsp;May 2024, Boehringer Ingelheim&nbsp;(Boehringer)&nbsp;announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the&nbsp;US.</p>