EMA strengthens the biosimilars pathway in Europe
Industry welcomes revisions of key principles for biosimilar guidelines.
BRUSSELS, Belgium - November 5, 2013 – European Biopharmaceutical Enterprises (EBE) and EuropaBio, industry organisations representing companies engaged in the research, development, manufacturing and marketing of new medicinal products using biotechnology, as well as the views of companies developing both novel biologics and biosimilars, applaud the European Medicines Agency (EMA) for hosting a thoughtful discussion on the EMA’s proposed overarching biosimilar guidelines. This meeting marks a continued programme of consultation with all stakeholders on the biosimilars pathway, and it is this programme of consultation that has helped to build trust and support for Europe’s global leadership in biosimilars.
"The revisions discussed offer important developments to further strengthen the biosimilars pathway in Europe,” said Eugene Corretge, Strategic Unit Regulatory Head at Sanofi and a speaker at the workshop, on behalf of EBE and EuropaBio. “We concur with EMA that while maintaining the requirement for a reference product authorised in the EEA, in the context of global development it may be possible to compare the candidate biosimilar with a non-EEA authorised comparator in certain non-clinical and clinical studies, provided that this is justified by the applicant through appropriate comparability studies between the reference product authorised in the EEA, the comparator product sourced elsewhere and the biosimilar candidate product."
The workshop also addressed the means by which the evidence supporting biosimilarity of a product for a given therapeutic indication might be extrapolated to other indications. In comments for EBE and EuropaBio, Richard Markus, Clinical Development Lead for Biosimilars at Amgen, emphasised:
“Data for extrapolation of indications in sensitive population could be required pre-approval. If questions haven't sufficiently addressed efficacy and safety, then regulators might ask for more data pre-approval - i.e. before granting those indications. We encourage regulators not to hesitate to ask for more data where it is needed. This approach may increase regulatory assurance and help build confidence in biosimilars amongst clinicians and patients.”
EBE and EuropaBio’s position on the guidelines remains that:
- Patient and physician confidence are key to biosimilar uptake;
- Resolving key efficacy or safety questions should never be a post-approval exercise;
- Increased specificity of standards are beneficial even in case-by-case evaluations;
- Good communication of the science behind approval combined with post-approval data on immunogenicity or rarer safety events, and the ability to rapidly detect signals for individual products will benefit both originator and biosimilar(s);
- The need for effective naming and global product-level traceability becomes ever more important as our healthcare systems adopt a more global exchange of pharmacovigilance data and global signal detection;
- Biosimilars are distinguished from generic products and other types of products in terms of the legal framework. For this reason, and also to be transparent for the physician and patient, it is important that the label mentions which studies were conducted and to specify which indications on the label were approved based on extrapolation of data and which indications were supported by clinical studies.
- We believe the guideline revision is an important opportunity for promoting a better understanding of the biosimilarity concept relative to innovative biologics and chemically-processed generic drugs.
The European Biopharmaceutical Enterprises (EBE) is the European trade association that represents biopharmaceutical companies of all sizes operating in Europe. It has 50 member companies - many of which are small and medium sized companies - engaged in the research, development, manufacturing and marketing of new medicinal products using biotechnology. EBE also operates as the biotechnology arm of EFPIA, the European pharmaceutical industry federation.
EuropaBio is the European Association for Bioindustries and was created in 1996 to provide a voice for the biotech industry in Europe. EuropaBio's mission is to promote an innovative and dynamic biotechnology-based industry in Europe.
EuropaBio represents large and small corporate members as well as associate members, Bio regions, and national biotechnology associations. Members of EuropaBio are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes. Our corporate members have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.
Director Regulatory Affairs, EBE
+32 2 626 25 76