Reports
EMA approved a record 28 biosimilars in 2024
In January 2025, the European Medicines Agency (EMA) released a report of its key figures for the authorization of new and biosimilar medicines in 2024. Highlights include groundbreaking treatments for Alzheimer’s, cancer, and severe infections, alongside 28 biosimilars enhancing access to affordable therapies. Oncology remained the dominant therapeutic area.
FTC reveals extent of PBM drug mark-ups and profits
In January 2025, the US’s Federal Trade Commission (FTC) published a second interim staff report examining the role of pharmacy benefit managers (PBMs) in the prescription drug industry, with a specific focus on specialty generic drugs.
Latin American patients face 4.7-year wait for innovative treatments
In October 2024, FIFARMA unveiled the third edition of its W.A.I.T (Waiting to Access to Innovative Therapies)Indicator report analysing the time it takes for innovative medicines to become accessible in Latin America.
Disruptor partnerships grow adalimumab biosimilar market share
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.
Top nine biological drugs by sales in 2023
The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.
New findings of semaglutide in managing hidradenitis suppurativa
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].
Challenges and solutions in addressing the development void for oncology biosimilars
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.
Role of biologicals and biosimilars in cancer treatment amidst rising cases
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].
FDA plans to standardize biosimilar approvals and boost access in FY 2025
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].
Decoding US IRA and Medicare drug price negotiations
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].
