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MD002152

New findings of semaglutide in managing hidradenitis suppurativa

Home/Reports | Posted 01/10/2024

At the recent EADV Congress (25 to 28 September 2024), a first-of-its-kind study demonstrated that semaglutide can significantly improve outcomes for obese patients with hidradenitis suppurativa (HS), a common and chronic skin condition. [1].

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Challenges and solutions in addressing the development void for oncology biosimilars

Home/Reports | Posted 13/08/2024

Europe's oncology sector remains dominant, bolstered by numerous biosimilars. Despite current growth, a decline in biosimilar development from 2025 threatens future access, requiring strategic interventions to sustain progress.

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Role of biologicals and biosimilars in cancer treatment amidst rising cases

Home/Reports | Posted 06/08/2024

At the 20th Biosimilars Medicines Conference held in April 2024, Aurelio Arias, Director of EMEA Thought Leadership at IQVIA, explored the risks and challenges associated with accessing cancer treatments involving biologicals and biosimilars [1]. 

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FDA plans to standardize biosimilar approvals and boost access in FY 2025

Home/Reports | Posted 30/07/2024

At the 20th Biosimilars Medicines Conference held in April 2024, Dr M Stacey Ricci* from the US Food and Drug Administration (FDA) presented information on the current status of FDA approvals of biosimilars, discussed the role of interchangeable biosimilars and their future development, and outlined the FY 25 legislative goals, including the elimination of the statutory distinction between the approval standards for biosimilar and interchangeable biosimilar products [1].

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Decoding US IRA and Medicare drug price negotiations

Home/Reports | Posted 25/06/2024

The Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) held a webinar on the 2022 Inflation Reduction Act (IRA), on 26 July 2023. An outline of this webinar, ‘Medicare drug price negotiations: impact on healthcare development and patient access to medicines’, was published in GaBI Journal [1].

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Highlights of EMA approvals in 2023 focus on cancer medicines

Home/Reports | Posted 14/05/2024

In its ‘2023 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.

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Follow-on biological/ biosimilar approvals in Latin America by therapeutic class

Home/Reports | Posted 03/04/2024

According to a review by Machado et al., 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].

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Follow-on biological/ biosimilar approvals landscape in Latin America

Home/Reports | Posted 27/03/2024

Machado et al. 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 [1].

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Biosimilars in cancer treatment in Europe and the US

Home/Reports | Posted 07/03/2024

The World Health Organization's (WHO) most recent projections suggest a staggering 77% surge in new cancer cases globally by 2050, compared to the approximate 20 million recorded in 2022. As a result, the anticipated number of cancer-related deaths worldwide is poised to double to around 18.5 million by 2050, in contrast to the 9.7 million reported in 2022. Alarmingly, numerous countries still lack sufficient resources allocated to treatment and care services.

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First approvals of similar biotherapeutics in seven Latin American countries

Home/Reports | Posted 16/01/2024

In their review, Machado et al. examine the transparency and regulatory guidelines pertaining to the licensing of biosimilars, as well as the count of biosimilars granted approval by 13 medicines regulatory authorities [1].