News & Events.

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, Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the&nbsp;medicinal product&nbsp;Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.</p>

22 Mar.

<p>In January 2024, Regeneron filed a lawsuit against Amgen in federal court in Los Angeles, alleging Amgen's proposed biosimilar of Regeneron's Eylea (aflibercept) violates patent rights.&nbsp;Additionally, in&nbsp;February 2024, Iceland-based Alvotech has announced the anticipated global market entry dates for AVT04, a ustekinumab biosimilar to Stelara, following its settlement with Johnson &amp; Johnson.</p>

22 Mar.

<p>The focus of the study by Vilha et al. [1] was to comprehend the role of the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), not only as a regulatory authority but also as a catalyst for technological development and innovation. ANVISA has implemented a significant change in the way health regulations are handled in Brazil.</p>

22 Mar.

<p> <b>20th Biosimilar Medicines Conference</b><br /> <b>18–19&nbsp;April 2024</b><br /> <b>Hilton Amsterdam Schiphol</b><br /><b>The Netherlands</b></p>

22 Mar.

<p> <b><b>18th Legal Affairs&nbsp;Conference</b></b><br /> <b>10</b><b>–</b><b>11 June 2024</b><br /> <b>Portmarnock Hotel &amp; Golf Links</b><br /> <b>Dublin</b><br /><b>Ireland</b></p>

22 Mar.

<p> <b>29th ANNUAL CONFERENCE</b><br /> <b>12</b><b>–</b><b>13 June 2024</b><br /> <b>Portmarnock Hotel &amp; Golf Links</b><br /> <b>Dublin</b><br /><b>Ireland</b></p>

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>

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