About the Campaign Engage in Global Biosimilars Week
Over
300
Biosimilar Approvals*
*Approvals in jurisdictions of IGBA membership as of 20 October 2020
Over
10
Therapeutic Areas Covered*
*Approvals in jurisdictions of IGBA membership as of 20 October 2020
Biosimilar Basics The Basics of Biosimilar Medicines
Biosimilars are biological medicines that are highly similar to an already-approved originator biological medicine, with no meaningful differences in efficacy and safety. Biological medicines, including biosimilars, are often large and complex molecules that are made from living cells using biotechnology. They are used to treat diseases such as diabetes, inflammatory diseases and cancer. Examples of biosimilar medicines include:
- Proteins such as insulin and growth hormones
- Larger and more complex proteins such as monoclonal antibodies
#globalbiosimilarsweek
Biosimilar Approvals Approval of Biosimilars Worldwide
Biosimilars are approved after rigorous scientific evaluation by regulators. They are manufactured to the same regulatory standards as originator biological medicines.- No biological medicines are strictly “identical” to themselves batch to batch, and patients and prescribers have years of experience taking ‘non-identical’ highly similar versions of the originator reference product. This same scientific principle used to manage variability of the reference biological product is applied to evaluating and approving biosimilars. Stakeholders should have trust and confidence in the regulatory agencies that approve both the reference product and the biosimilar medicine.
- Regulatory authorities globally have confirmed biosimilars to be “highly similar to the originator in quality and biological activity, with no clinically meaningful differences in efficacy, safety and immunogenicity.”
Benefits of Biosimilars Value of Biosimilars for Patients, Healthcare Professionals and Healthcare System
Biosimilars can provide alternative treatment options for existing standards of care in several disease areas, creating enhanced availability and access to biologic medicines. Biosimilars create cost competition that benefit patients, healthcare professionals and healthcare systems.
- According to a 2017 study, the availability of biosimilar medicines could increase patient access to biologic therapy overall to more than a million additional patients. Read More
View patients stories: Jeni’s Story Helen’s Story
Clinical Use and Market Adoption Vast Experience with Biosimilar Medicines
Trust and confidence in biosimilar medicines has grown steadily along with clinical experience. Governments and payers around the world have adopted policies featuring newly created incentives for increased biosimilars development and adoption in the clinical practice. Millions of people around the world can live longer, healthier lives thanks to greater access to biologic therapies, including biosimilars.
Future Opportunities What’s next?
Ensuring continued benefit of biosimilars for patient access to biologic medicines and health system sustainability is dependent on the decisions made today. While biosimilar regulatory approvals have increased globally, biosimilar medicines still face uptake challenges in many countries. Increasing biosimilar availability could provide significant value for health care systems, enabling resources to be re-invested where most needed by patients, health care professionals and healthcare systems. Opportunities to share information across borders, like Global Biosimilars Week, can spread real world experience with the clinical use of biosimilar medicines to help identify the key enablers for patients, medical professionals, policymakers and other healthcare stakeholders to foster greater adoption of biosimilar medicines.
What you can do now? | ||
GLOBAL BIOSIMILARS WEEK Resources
IGBA Member Associations
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Tel: +32 (0)2 736 84 11
Fax: +32 (0)2 736 74 38
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Fax: +32 (0)2 736 74 38
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How can #biosimilars change the treatment landscape?
Biosimilars play a meaningful role in potentially expanding access to lower-cost treatment options and supporting health system resiliency. See how we’re reimagining medicine: https://bit.ly/3eZyVx6