Global Roadmap for Tailored Clinical Biosimilar Development: Instrumental for Sustainable Access to Biologics

Monday September 28, 2020

Following its first peer-reviewed scientific paper on biosimilar medicines development: the Path Towards Tailored Clinical Biosimilar Development (BioDrugs), the International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today released a new policy paper: “Developing a Regulatory Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development.”


Biologic medicines are complex medicines developed in living cells that offer treatment options for patients suffering from many serious conditions, such as cancer, diabetes and rheumatoid arthritis. Biosimilar medicines are versions of biologic medicines that have no meaningful differences in safety or efficacy/effectiveness and enable competition following resolution of market exclusivity periods. They have vast potential to improve the cost-effectiveness of biologic therapies and provide broader access to medicines for patients.

Health inequities remain significant in communities around the world, across the range of health care services and products, and this is particularly true for biologic therapies. Biologics have revolutionized the treatment landscape for many diseases, but at a significant financial cost to health systems and patients. Despite the advent of biosimilar competitors, equity in access to biologic therapies remains a challenge, in large part due to systemic hurdles preventing optimal use of biosimilar medicines.

Policy-makers at all levels can play a role in fostering an environment conducive to maximizing the potential of biosimilar medicines to reduce inequities in healthcare. Biosimilar medicines not only expand access to current treatments previously out of reach for some patients, they also allow health systems to provide increased access to innovative treatments, diagnostics and cures through more efficient use of available funds. The global community has committed to achieving Sustainable Development Goal 3: Ensuring healthy lives and promoting well-being for all at all ages, including reducing by one-third premature mortality from non-communicable diseases by 2030.

Equitable access to safe, effective, quality and affordable medicines is a critical component of achieving this collective goal. Ensuring that patients get the medicines they need, today and in the future, requires collaboration between all affected stakeholders, including regulatory authorities, pricing and reimbursement agencies, payors, medical societies, healthcare providers and patients.

Regulatory authorities play a central role in creating a sustainable environment for biosimilar medicine development, approval and patient access. Building on their considerable scientific knowledge and cumulative experience with biologic medicines, regulators can expand access to biologic medicines by expediting biosimilar approval and ensuring accurate healthcare stakeholder understanding of biosimilarity to translate approval to appropriate utilization. This can be achieved by coupling tailored clinical development with advanced comparative analytics and educating stakeholders on the quality, safety and efficacy of biosimilar medicines and the comparative utility of analytical and clinical data to support biosimilarity.

Adapting the biosimilar development paradigm to encourage tailored clinical development programs will facilitate development of these products by ensuring that the studies are designed to quickly and precisely provide the relevant and definitive data to establish that a biosimilar will have no clinically meaningful difference to the biologic that it is designed to match. This in turn will have a direct impact on the sustainability of biosimilar competition and contribute to increased patient access.

About IGBA

The International Generic and Biosimilar medicines Association (IGBA) was founded to strengthen cooperation between associations representing manufacturers of generic and biosimilar medicines from around the world. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality, pro-competitive medicines. For more details, regarding IGBA and its member associations, see the IGBA website at:

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.