News & Events.

22 May.

<p>On 21 March 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&nbsp;(MA)&nbsp;for Outlook Therapeutics’ Lytenava (ONS-5010, bevacizumab gamma),&nbsp;intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).</p>

22 May.

<p>In April 2024, the&nbsp;UK’s&nbsp;Medicines and Healthcare products Regulatory Agency (MHRA) published a policy paper on its strategic approach to artificial intelligence (AI) [1]. It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023 [2] and is the agency’s response to the Secretary of State letter of 1 February 2024 [3].</p>

22 May.

<p>A&nbsp;GaBIJ Review Article&nbsp;entitled ‘Trends in Saudi FDA drug approvals and GMP inspections: an observational study’, was published by a group of authors,&nbsp;<i>Alhomaidan et al.,</i>&nbsp;from&nbsp;Saudi Food and Drug Authority (SFDA)&nbsp;in October 2023 [1].</p>

14 May.

<p>In Canada, three biosimilars were approved in late 2023. These are, Amgen’s Wezlana (ustekinumab), JAMP/Alvotech’s&nbsp;Jamteki (ustekinumab), and Formycon/Polpharma Biologics/Bioeq’s&nbsp;Ranopto (ranibizumab).</p>

14 May.

<p>Bio-Thera Solutions (Bio-Thera) announced in March 2024 a licensing agreement with SteinCares to market two biosimilars in Brazil and the rest of the region.</p>

14 May.

<p>In its&nbsp;‘2023&nbsp;Human Medicines Highlights’, the European Medicines Agency (EMA) provided a comprehensive overview of key recommendations for the approval of medicines in various therapeutic areas. Notably, the report highlighted significant advancements in cancer treatment approvals, including cancer biosimilar.</p>

07 May.

<p>On 21 March 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for&nbsp;Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair.</p>

07 May.

<p>In April 2024, Henlius Biotech and Organon announced that the phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14) met the primary endpoints. This follows the news released earlier in the year, that Alvotech and Polpharma achieved positive topline results from their pharmacokinetic (PK) studies for their denosumab biosimilar candidate (AVT03). The originator product is Amgen’s Prolia/Xgeva.</p>

07 May.

<p>In March 2024, Formycon and MS Pharma announced that their&nbsp;FYB201/ranibizumab Ravegza, a biosimilar to Lucentis, has received marketing authorization from the Saudi Food &amp; Drug Authority.</p>

16 Apr.

<p>On 3 April 2024,&nbsp;China-based biopharmaceutical company&nbsp;Mabwell announced that their Maiweijian (denosumab) injection, developed by its&nbsp;wholly owned&nbsp;subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab&nbsp;copy biologicalto receive marketing approval in China.</p>

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