News & Events.

06 Feb.

<p>On 6 December 2024, Health Canada approved Celltrion’s Omlyclo (CT-P39) omalizumab biosimilar – the first and only omalizumab biosimilar currently available in Canada. The product is a biosimilar of Novartis’ Xolair.&nbsp;</p>

06 Feb.

<p>In January 2025, the International Council for Harmonisation (ICH) announced the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical studies [1, 2].</p>

06 Feb.

<p>Klinge Biopharma (Klinge) and Teva Pharmaceuticals (Teva) formed a semi-exclusive agreement for the commercialization of Formycon’s FYB203 biosimilar to Eylea (aflibercept)&nbsp;in Europe, while MS Pharma partners for the MENA (Middle East and North Africa)&nbsp;commercialization of FYB202, a biosimilar to Stelara&nbsp;(ustekinumab).</p>

28 Jan.

<p>In November 2024, at the American College of Rheumatology (ACR) Convergence 2024, Alvotech shared the positive results of the primary endpoint of their comparable safety and efficacy study for their golimumab proposed biosimilar, AVT05 [1]. This is a biosimilar candidate to Janssen Biotech’s anti-inflammatory drug product, Simponi.</p>

28 Jan.

<p>On12 December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two more biosimilars: Celltrion’s Avtozma and CuraTeQ Biologics’ Zefylti.</p>

21 Jan.

<p>In late 2024 and early 2025, multiple ustekinumab biosimilars, including Yesintek, Steqeyma, and Otulfi, which are biosimilars referencing Janssen/Johnson &amp; Johnson’s (J&amp;J) Stelara,&nbsp;received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment options for Crohn’s disease, psoriasis related conditions, and ulcerative colitis.</p>

21 Jan.

<p>In the US, the interchangeability designation earned by some biosimilars, now allows them to be substituted at pharmacy level, without physician approval. This has bolstered patient and physician confidence in these products, boosting their uptake. However, study published in&nbsp;<i>GaBI Journal</i>&nbsp;now examines how misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health [1].</p>

21 Jan.

<p>China is emerging as a global biotech leader, attracting significant investment and partnerships from multinational pharmaceutical companies. Its innovative therapies and biosimilars are gaining international traction, reshaping the industry despite ongoing challenges.</p>

15 Jan.

<p>The&nbsp;European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion&nbsp;recommending the granting of marketing authorization&nbsp;for four denosumab biosimilars:&nbsp;Obodence and Xbryk (SB16), developed by&nbsp;Samsung Bioepis, on 14 November 2024, and&nbsp;Stoboclo and&nbsp;Osenvelt&nbsp;(CT-P41), developed by Celltrion, on 12 December 2024. These&nbsp;biosimilars are based on Amgen’s reference products Prolia and Xgeva, respectively.&nbsp;</p>

15 Jan.

<p>Despite 10 biosimilar versions of Humira (adalimumab) being available in the US market since 2023, their uptake has remained low. Humira retained 97% of its market share for adalimumab through to March 2024. However, now, a new form of partnership has allowed adalimumab biosimilars to increase their market share.&nbsp;</p>

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