What are “Biosimilars”?
After patent expiry, biopharmaceuticals can also be produced and marketed by manufacturers other than the originator, subject to strict regulatory approval. These new biotechnology medicines are known as “biosimilars” (or similar biological medicinal products) because the new biological medicinal product is claimed to be “similar” to an already approved reference product.
Europe has been the first region to establish a specific regulatory approval process for biosimilars. This regulatory framework lays down a clear biosimilar approval pathway, based on scientific data and the same stringent standards required for original products. It takes a case-by-case approach both for changes to the manufacturing processes of existing
biopharmaceuticals and for the approval of new biosimilar products. Comparative quality, non-clinical and clinical studies have to be provided by the biosimilar manufacturer to substantiate the similarity of structure/composition, quality, safety and efficacy between the new biosimilar and the chosen reference medicinal product.
Since 2006, 13 biosimilars have received European regulatory approval, so biosimilars have recently become a commercial reality in European markets.
EBE addresses issues around Biosimilars
The use of biosimilars in clinical practice introduces new challenges that are not presented by small molecule generic medicines. Because of the variability and complexity of large
biological molecules, a biosimilar can only be proven to be similar and not identical to its reference product.
EBE has contributed to the establishment of a robust science-based EU approval framework for biosimilars, but a number of issues remain to be addressed. To this end, EBE has recently published position papers and made recommendations on behalf of the innovator industry to the European Commission and EMA on issues like biosimilar naming, labelling, substitution, interchangeability and pharmacovigilance. These specific issues can be summarized as follows:
1. The naming of biosimilars
In order to facilitate effective pharmacovigilance monitoring and tracing of adverse safety events, and to prevent inappropriate substitution, the product (innovator or biosimilar) prescribed and dispensed to the patient should be clearly identified.
2. The interchangeability of biosimilars and their reference products
In the absence of convincing scientific and clinical evidence, interchangeability between a biosimilar product and its reference product may present a potential risk to patient safety, and regulatory guidance is recommended in this regard.
3. Automatic substitution
This practice – by which a different product to the one specified on the prescription is dispensed to the patient without the prior informed consent of the treating physician – should not apply to biosimilars.
4. The labelling of biosimilar products
Labelling should provide transparent information to healthcare professionals and patients on issues that are relevant to the safe and effective use of the medicinal product
- EBE Position Paper on Biologicals Tendering - final 03-05-12.pdf
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- EBE Position Paper on Biologicals Substitution_26 january 2011.pdf
(248.362 KBkb) Download
- EBE Comments_on EMA Concept Paper on Biosimilars mAbs_jan10.pdf
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- EBE Comments on Guideline on Clinical and Non-Clinical Development of Biosimilars Containing EPO_jan10.pdf
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- EBE/EFPIA Comments on Guideline on Biosimilars Containing Low Molecular Weight Heparins_oct08.pdf
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- EMEA Q&A on Biosimilars, 19 April 2007
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- EBE Comments on EMEA draft guideline on Comparability _apr07.pdf
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- EBE-EFPIA Biosimilars labelling position paper, 28 March 2007.pdf
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- EBE-EFPIA Position Paper on Biosimilars Substitution, 31 July 2006
(194.133 KBkb) Download
- EBE-EFPIA Position Paper on Naming of Biosimilars, 7 July 2006
(215.507 KBkb) Download
- EBE comments to EMEA draft Concept Paper on Immunogenicity, May 2006
(163.422 KBkb) Download
- EBE Comments to EMEA draft Guideline on Biosimilars, (non)Clinical issues, October 2005
(256.928 KBkb) Download
- EBE comments to EMEA draft Guideline on Biosimilars, Quality issues, June 2005
(311.352 KBkb) Download