© Novasep-Henogen SA photo by Ary
The European Medicines Agency (EMEA), the European equivalent to the Food and Drug Administration (FDA), has implemented an approval scheme that specifically distinguishes between biosimilars (follow-on biologics) and generic drugs. The EMEA recognized that "due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products." /1
Legislation passed by the European Parliament protects and fosters innovation by providing ten years of data exclusivity for innovator drugs and biologics against generics, hybrids, and similar biological products, /2 in contrast with the five year exclusivity for new molecular entities that is provided in the United States. The ten-year period may be extended for an additional year, for a total of 11 years of data exclusivity, with respect to certain new indications.
The EMEA guidelines recognize the importance of patient safety and the need to minimize the risk to the patient by establishing a regulatory framework that will require extensive testing before approval. Without such testing, patients cannot be assured that their biological therapies are safe and effective.
Importantly, the EMEA recognized that there may be safety and efficacy differences between seemingly similar products. Accordingly, the EMEA has taken a case-by-case approach to similar biological products, and has said that any "differences between the similar biological medicinal product and the reference (innovator) medicinal product will have to be justified by appropriate studies on a case-by-case basis." /3 The EMEA has indicated that such studies will typically include clinical trials. /4 Safety data will be needed because, as the EMEA noted, a similar biological product may have a different safety profile from the reference product even if the efficacy is comparable.
The EU recognizes that biosimilars are different from existing biological therapies in terms of their raw materials and manufacturing processes and that even slight differences can significantly alter a biological therapy's safety and effectiveness. Therefore, EMEA recognizes the potential for a biosimilar to exhibit immunogenicity problems that were not detected in clinical trials and do not occur with the innovative product, and it requires that biosimilars undergo post-marketing monitoring like that required for new innovative biologics.
EMEA used a public and transparent process to obtain input to establish the general testing requirements for biosimilars and then also used a transparent and public process to establish testing requirements for certain individual product types, without inappropriate reliance on innovators' trade secret or confidential commercial information.
/1 Guideline on Similar Biological Medicinal Products, EMEA Committee For Medicinal Products for Human Use (October 30, 2005) ("EMEA Guideline on Similar Biological Products") at 4.
/2 Article 14(11) of Regulation (EC) No. 726/2004; and see also What is the Period of Protection for My Medicinal Product?, EMEA.
/3 Id. at 5.
/4 Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues, EMEA Committee For Medicinal Products for Human Use (February 22, 2006) at 5-6.