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5 Key Facts About Biosimilar MedicinesBiological medicines (or “biologics”) have already transformed the lives of millions of patients.1 Biosimilars are biologics that are made by di� erent pharmaceutical companies when patents expire on original brand biologics.

References1. European Commission. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products.

http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/native. Accessed April 2020.

2. Information on Biosimilars. FDA. Available from: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars?source=govdelivery. Accessed April 2020.

3. Weise M. et al, Blood. 2012;120(26):5111-5117, Accessed April 2020.

4. Schneider CK, Ann Rheum Dis. 2013 Mar;72(3):315-8. doi: 10.1136/annrheumdis-2012-202941, Accessed April 2020.

5. Periodic Safety Update Reports. Data on fi le.

HQ/SDZ/16-0001(1)c(1)

Biosimilars = Biologics• To be approved for use, a biosimilar has to

match the reference medicine in terms of safety and e� cacy in patients, demonstrating no clinically meaningful di� erences.2

• Think of an original brand biologic and a biosimilar like an original key and another version that a locksmith makes. Both keys produce the same result; both will fi t the same lock and open the same door, even if there are slight di� erences between the original key and another version of the key.

Made in living cells = Variation• Biologics are made in, or extracted from, living

cells (bacteria, yeast, or mammalian cells are often used).1

• Because they are made in living cells all biologics, including reference biologics, vary from batch to batch.3 Manufacturing changes that happen during the lifetime of a biologic can also cause variations.4

Biosimilars open the door to help millions more• Biosimilars are available in almost 100 countries around the world including those in Europe as well as

Australia, Canada, Japan and the US.5

Variation is controlled• Think of variability and the way it is managed

like scoring goals in football or soccer. You have to get the ball within the precise range set by the goal posts. However, you can vary whether you get the ball in at the top corner, bottom corner or down the middle; the result is the same, you’ve scored a goal.

• Every batch of every biologic medicine, including biosimilars, has to stay within precise ranges to ensure that any variations do not lead to a “di� erent” medicine in terms of safety and e� cacy.1

Equivalent results for patients• “Biosimilarity” is established through a stepwise

process based on comparisons between the biosimilar and the original brand biologic looking most closely at quality, e� cacy and safety.1

• Biosimilar medicines are approved by the same regulatory authorities, with the same scientifi c rigour, using the same regulatory systems as original brand biologics.

E� cacy Safety

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