Source – Novartis
On June 15, a global plan to improve patient access to biologic medicines was launched, according to Sandoz, a pioneer in generic and biosimilar medications. The Act4 Biosimilars Action Plan is a component of the Sandoz-founded Act4 Biosimilars programme, which was introduced in 2022 and intends to raise Biosimilar acceptance globally by at least 30% in at least 30 countries by 2030.
“The time to globalize biosimilars is now, so that advanced biologic medicines are accessible to patients who need them most. Their benefits are proven, and it’s time to bring them to more patients and health systems across the world.”
– Professor Emeritus Tore K. Kvien, previous Head of Department of Rheumatology, Diakonhjemmet Hospital for 25 years and a member of the Act4 Biosimilars Steering Committee
The Act4 Biosimilars Action Plan identifies the most important obstacles impeding patient access to biosimilar medications and offers doable solutions to hasten adoption. A series of papers that analyze the main issues by area will be included in the Action Plan as a supplement. The Americas are the first region to be highlighted, and the following observations are made:
- In the United States, the interchangeability regulatory guidelines have caused confusion among patients and healthcare professionals.
- Due to gaps in the regulatory pathways, patients in Colombia and Ecuador can be exposed to biocopies which may not meet the rigorous international guidelines provided by the World Health Organization (WHO) for the approval of Biosimilars.
- In Canada, the United States and Brazil, educational materials exist, however a lack of alignment across stakeholder groups on the materials has led to confusion amongst healthcare professionals and patients.
- Unsustainable procurement practices, such as single-winner tenders, are common in Mexico and Brazil, creating supply continuity risks and potential disruptions to patient care.
The Action Plan includes 12 important measures to speed up the adoption of biosimilars across the 4As — Approvability, Acceptability, Accessibility, and Affordability – in order to overcome these and other difficulties. It offers practical suggestions for local stakeholders to improve the environment for biosimilars in their nation and eventually promote worldwide acceptance.
“Biosimilars can be life-changing for patients and their families and can play a critical role in overcoming health inequalities seen across the world. As a stakeholder-driven initiative, Act4 Biosimilars aims to empower local stakeholders on the ground, who are passionate about increasing patient access to advanced medicines. We are asking them to download the Action Plan, use the information provided, and join the movement to increase biosimilar adoption.”
– Laura Wingate, Executive Vice President, Education, Support & Advocacy at the Crohn’s & Colitis Foundation