As biosimilars become more prevalent in countries around the world, a question arises: Are the savings from these often cheaper agents benefiting the healthcare consumer?
âWhen competition with biosimilars sets in, there is no policy supporting the reinvestment of savings in more patients with access,â said Suzette Kox, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), during a webinar sponsored by IGBA, a business group of pharmaceutical developers and manufacturers. The occasion was the launch of a white paper that the group called a blueprint for the future development of the generic and biosimilar industry.
“It is indeed very complicated to ensure that biosimilars that are approved and ultimately available on the market really benefit patients and health systems,” said Kox.
The problem of how to ensure savings and access arises in different forms. “We have over 30 biosimilars registered in Brazil, but only 5 of them are available for our population, and these are focused on treatments for cancer and rheumatic diseases,” said panelist Gustavo Santos, director general drug and biological products to ANVISA, the Brazilian Health Regulatory Agency.
In markets where many more biosimilars are available, manufacturers are increasingly expected to participate to ensure that the availability of generics and biosimilars is supported by ‘end-to-end solutions’ that contribute to improved health outcomes, according to the IGBA white paper.
âRather than acting as a supplier of this trend, the industry should play a central role in the development of these solutionsâ¦. Generic and biosimilar companies should span the entire continuum of care and partner effectively with diagnostic providers, healthcare providers and technology companies to deliver patient-centered solutions, âwrote the authors of the article.
The white paper described a rapid advance in the use of biosimilars over the past 5 years, which it said was supported by streamlining regulatory guidelines and “increasingly positive clinical experience”. In Germany, for example, the biosimilar versions of adalimumab, bevacizumab and rituximab achieved 72%, 80% and 85% market share, respectively, according to the IGBA article.
“Going forward, the market is expected to experience continued double-digit growth with the potential for the industry to expand significantly,” the authors wrote, but said this would depend on the continued development of the biosimilars market in the States. -United with a favorable regulatory policy and growing stakeholder acceptance.
Further opportunities for biosimilar development present themselves with the anticipated loss of exclusivity (patent protection) for biologics of multiple origin, which means that biosimilar developers can diversify away from basic biologics on which they have leaned so far, the authors wrote. Other products in oncology and autoimmune diseases are possible.
“As a result, the cumulative savings from biosimilars are expected to reach $ 285 billion worldwide over the next 5 years, with annual savings exceeding $ 100 billion in 2025 alone,” the report predicts.
The competitive climate
However, the competitive atmosphere is expected to become more intense.
“Only the first entrants [in a therapeutic drug category] have the potential to recoup the significant investments made in product development. As a result, “biosimilar launches have also witnessed an acceleration in price erosion in the markets,” wrote the authors of the article.
They stated that the recent anti-tumor necrosis factor biosimilars, upon launch, saw price drops of around 25% when the first biosimilar hit the market, but when multiple competitors enter the same market and are forced to outbid each other to secure supply contracts â, erosion can reach up to 70% fairly quickly.
“Persistent price pressure will require tight control of operating costs beyond the bare minimum required by industry to deliver high quality products, especially in light of rising input costs,” wrote the authors. They expressed concerns about the long-term consequences of this economic pressure.
For the penetration of biosimilars into the markets of emerging countries, the cooperation of regulators is necessary. Regulatory frameworks in some cases are not conducive to bringing biosimilars to market, approval processes may be too complex, approval timelines may not be well defined, and clinical trial design requirements may not be well defined. not be clear, they wrote.
“While emerging markets represent a traditional growth opportunity and a key playing field for better access to medicines, they also present serious competitive and structural challenges for manufacturers of generics and biosimilars,” said the authors of the report. .
The Center for BiosimilarsÂ® recently interviewed members of Medicines for Europe about their comprehensive review of the European Union markets for biosimilars. This interview is presented in 2 parts, the first of which is available on this link.