News & Events.

09 Apr.

<p>On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.&nbsp;</p>

09 Apr.

<p>In February 2024, Mexico’s COFEPRIS (<i>Comisión Federal para la Protección contra Riesgos Sanitarios</i>) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.</p>

09 Apr.

<p>mAbxience announced in February 2024&nbsp;a pivotal agreement with Biosidus to manufacture Agalsidase Beta. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease.</p>

03 Apr.

<p>The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.</p>

03 Apr.

<p>Biosimilar products, vital for widening access to essential treatments and reducing healthcare costs, face varied uptake influenced by factors like pricing and healthcare settings. Kozlowski et al.'s study compares adoption rates in Medicare Advantage (MA) and Traditional Medicare (TM), revealing significant differences [1].</p>

03 Apr.

<p>According to a review by&nbsp;Machado&nbsp;et al.,&nbsp;across seven Latin American nations, biosimilar approval patterns diverge from Canada, Europe, and the US. Anti-anaemic and diabetes treatments are notably lacking approvals, while Brazil emerges as a leader in biosimilar authorization [1].</p>

27 Mar.

<p>A&nbsp;GaBIJ&nbsp;perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of authors from Biocon Biologics in August 2023 [1].</p>

27 Mar.

<p>On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK.</p>

27 Mar.

<p>Machado&nbsp;et al.&nbsp;analyse the clarity and regulatory guidelines associated with the approval process for biosimilars. Additionally, they examine the quantity of biosimilars that have received approval from 13 different medicines regulatory authorities in their review&nbsp;[1].</p>

22 Mar.

<p>On 22 February 2024, the European Medicines Agency’s&nbsp;Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the&nbsp;medicinal product&nbsp;Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.</p>

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