Sandoz intros Act4Biosimilars Action Plan

Sandoz is launching The Act4Biosimilars Action Plan, which is part of the Act4Biosimilars initiative, founded by Sandoz and launched in 2022, which aims to increase global biosimilar adoption by at least 30 percentage points in more than 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,” said professor emeritus Tore Kvien, previous head of the department of rheumatology at Diakonhjemmet Hospital for 25 years and a member of the Act4Biosimilars Steering Committee.

The Act4Biosimilars Action Plan highlights the most critical challenges preventing patient access to biosimilar medicines, as well as actionable steps to accelerate adoption by overcoming those challenges. The Action Plan will be complemented by a series of reports which provides an analysis of the key challenges by region. The first region spotlighted is the Americas and includes the following insights:

• 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 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; and
• Unsustainable procurement practices, such as single-winner tenders, are common in Mexico and Brazil, creating supply continuity risks and potential disruptions to patient care.

To address these and other challenges, the Action Plan features 12 key initiatives to accelerate biosimilar adoption across the 4As – Approvability, Acceptability, Accessibility, and Affordability. It provides actionable steps designed to help local stakeholders foster a more favorable environment for biosimilars in their country and ultimately drive global adoption.

Laura Wingate, executive vice president of education, support and advocacy at the Crohn’s & Colitis Foundation said, “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, Act4Biosimilars 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.”

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

The Steering Committee is working with local stakeholders across the Americas to implement the Action Plan and identify and address the key challenges holding back wider biosimilar adoption. The Steering Committee will turn its focus to Europe in Q4 2023, the Middle East and Africa in Q1 2024, and Asia Pacific in Q2 2024.

Arnold Vulto, an independent consultant and educator at VuPEC, said, “All healthcare stakeholders play an important role in improving patient access to biosimilars. So whether you’re a physician, nurse, pharmacist, payer or a patient, look for possibilities on how biosimilars can benefit your health system and patients. I encourage you to join the Act4Biosimilars movement as collaboration is the driving force behind the initiative, and those committed to the Mission should get in touch.”

For nearly two decades, the introduction of biosimilars has enabled expanded or earlier patient access to biologic treatment. It is estimated that between 2023 and 2027, biosimilars could generate $290 billion in savings globally. However, biosimilars are still unavailable in most countries and there are significant challenges to expand access. As a result, their impact on patients varies widely, Sandoz noted.

The Act4Biosimilars Impact Index will measure and assess progress for 30 initiative-tracked countries in relation to the favorability of the local environment towards biosimilars, under each of the 4As. The Index will be updated every two years, to give local stakeholders shared visibility and understanding of the most critical issues preventing biosimilar adoption.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

Act4Biosimilars aims to achieve a biosimilar adoption rate of 44% by 2030 across 30 countries in the scope of tracking. This is a 30 percentage point increase on the baseline figure of 14% from 2022. These figures are based on comparing the volume of biosimilars against the reference medicine for each molecule for which a biosimilar is already available or expected to be made available by 2030.