Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030

A new roadmap from Sandoz aims to provide actionable steps to overcome key challenges and increase biosimilar adoption worldwide. The Act4Biosimilars Action Plan is part of the Act4Biosimiliars initiative, which has the goal of increasing biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.

After nearly 20 years, biosimilars have reached an adoption rate of only 14% in the countries tracked by Sandoz’ initiative, and biologic treatments still maintain 86% of market share.

“Biosimilars can be life-changing for patients and their families and can play a critical role in overcoming health inequalities seen across the world,” Laura Wingate, executive vice president, Education, Support & Advocacy at the Crohn’s & Colitis Foundation, said in a statement. “As a stakeholder-driven initiative, Act4Biosimilars aims to empower local stakeholders on the ground, who are passionate about increasing patient access to advanced medicines.”

To address the challenges, the plan features initiatives across 4 focus areas:

• Approvability: (1) level the playing field for robust dossiers by adopting rigorous regulatory pathways and (2) streamline biosimilars approval by optimizing regulatory review procedures
• Acceptability: (1) use fair and accurate information to fight disinformation by driving publication of authoritative local educational content; (2) share experiences of biosimilar use across countries through an international exchange of real-world biosimilar evidence; and (3) involve patients in treatment decisions by incentivizing patient education by providers when patients start on biosimilars.
• Accessibility: (1) create biosimilars markets and improve peer-to-peer exchange between providers to elevate trust in biosimilars; (2) create strong policies for switching to biosimilars moving from forced switching to informed switching; (3) create clear medical guidelines and educate stakeholders on prescribing and accessing biosimilars in the local market; and (4) respond to loss of market exclusivity by increasing awareness of biosimilar availability dates.
• Affordability: (1) open dialogue between producers, tenderers, and insurers and raise awareness of the benefits to the health system as a result of biosimilar savings; (2) ensure equitable pricing by introducing and widening adoption of sustainable biosimilar pricing policies; and (3) promote fair competition and swift market access by increasing local market competition.

The Act4Biosimilars Action Plan seeks to increase biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.

The first report focuses on the Americas and includes Brazil, Canada, Chile, Colombia, Ecuador, Mexico, and the United States. Only Canada received a high favorability rating for biosimilars based on local policies, regulatory systems, and key stakeholders. The United States, Mexico, and Brazil rated medium, and Chile, Colombia, and Ecuador rated low favorability.

Among the key challenges highlighted were the varying levels of adoption across the region and significant challenges in the United States due to reimbursement policies and misalignment with incentives in the health care delivery system.

In the United States, the report notes that interchangeability guidelines, which create confusion and “propagate misperceptions about biosimilars,” should be revised. Meanwhile, Colombia and Ecuador allow biocopies, which are noncomparable biologics and create patient safety risks.

Education is also important for biosimilar adoption, and the report identified a need for a multistakeholder approach to education rather than education efforts led by a single stakeholder group, which is often the case in Brazil, Canada, and the United States.

The complications of the health care system in the United States also reduces access to biosimilars by disincentivizing their use. The use of rebates encourages people to favor high-cost medicines. In addition, a court ruled against the use of “skinny labels,” which are used by biosimilar manufacturers to bring biosimilars to market quicker by omitting indications still under patent.

“In 2020 alone, ‘skinny labels’ on biosimilars generated savings of $857 million and this act therefore puts in jeopardy access for patients to advanced medicines and the millions of dollars’ savings that could be generated from early biosimilar access,” according to the report.

In fourth quarter 2023, the focus will be on Europe, followed by the Middle East and Africa in quarter 1 2024, and Asia Pacific in quarter 2 2024.