Reports

China-to-West pharma licensing deals surge in 2024 amid innovation push

Home/Reports | Posted 22/05/2025

A recent analysis of 48 pharmaceutical licensing deals from Chinese to Western companies in 2024 reveals a surge worth US$8.4 billion, with 31% of major pharmaceutical companies' innovative pipeline assets being in-licensed from China [1]. The Nature Reviews Business Brief, written by Leon Tang, examines data from investment bank Stifel’s report, ‘Biopharmaceutical Outlook for 2025’ [2].

EMA approved a record 28 biosimilars in 2024

Home/Reports | Posted 28/03/2025

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

Home/Reports | Posted 12/03/2025

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

Home/Reports | Posted 18/02/2025

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

Home/Reports | Posted 15/01/2025

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

Home/Reports | Posted 29/10/2024

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

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].

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.

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].

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].

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].

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.

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].

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].

Benefits of innovative biologicals and biosimilars for patients and health systems

Home/Reports | Posted 04/02/2022

A report carried out by several authors showed that if the launch of biotechnological drugs unleashed controversy at the time due to their novelty, those of biosimilars were even greater. Fifteen years after the launch of the first biosimilar and taking into account current regulations, the question remains as to whether they represent opportunities or risks in terms of safety, effectiveness and costs for patients, physicians and health systems. The challenges are to educate and communicate in a broad and sustained manner about scientific innovation in pharmaco-biology, the value of innovators, and the evidence of effectiveness and safety of biosimilars [1].

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.

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].

Biosimilar terminology: insights from seven Latin American countries

Home/Reports | Posted 05/12/2023

In a review by Machado et.al., the authors examine the transparency and guidelines for biosimilars licensing and the number of biosimilars approved by 13 medicines regulatory authorities. In this context, we focused the discussion on seven Latin American countries: Argentina, Brazil, Chile, Colombia, Guatemala, Mexico and Peru as part of the broader review [1].

Biopharmaceutical industry in Argentina in the 21st century

Home/Reports | Posted 31/10/2023

In the dynamic landscape of Latin America's pharmaceutical industry, Argentina stands out with its distinctive structure and policies that have shaped its biopharmaceutical sector. Over the course of this century, the biopharmaceutical industry in Argentina has emerged as a critical player in the country's healthcare sector.

Emerging disparities in market concentration among biosimilars

Home/Reports | Posted 22/09/2023

Biosimilars are an essential element of sustainable healthcare systems, with significant potential contribution to competitive markets. However, there are still challenges to be faced; for instance, there is a growing trend of biosimilar development targeting a limited range of biologicals [1].

Generics and biosimilars Initiative

News

Research

General