Biosimilars are a reality and with the patent expiries of monoclonal antibodies, this market will grow rapidly. According to IMS Health, by 2015, spending on biosimilars will exceed US$2 billion annually.
Genentech, a subsidiary of Roche group, is one of the biggest players in the biotechnology area and their products are “under attack” by biosimilar manufacturers. Herceptin and Rituxan/MabThera are the two blockbuster products which are used in different types of cancer and it is known that, biosimilar manufacturers like Celltrion, Teva and Sandoz are developing their own versions of these two products.
Therefore, we should also keep an eye on the originators position; in their own website, Genentech has a position paper about biosimilars:
Genentech declares that, each clinical indication for a biosimilar should be established by indication-specific clinical trials to ensure the safety and efficacy of the biosimilar. Biosimilars should only be substituted for an innovator biologic if comparative clinical trials demonstrate that substitution is appropriate; and biosimilars should be uniquely identified and should be traceable to ensure patient safety.
As expected, Genentech believes that, indication extrapolation should not be possible and indication-specific clinical trials should be concluded to have the same indications with the originator.
Additionally, substitution and interchangeability which is not possible in major EU countries, should be demonstrated with clinical trials Genentech says. But biosimilar manufacturers argue this opinion and suggest that, differences exist within different batches of reference products and authorities allow the interchangeability between the originator batches. For more information about interchangeability, you can also check this article.
Product identifiability and traceability was always a concern and originators have suggested that biosimilars should have a different INN name. In the EU, only one biosimilar was approved with a different INN name (epoetin zeta), the others have the same INN name with the originators.
Different INN names are not required but Risk Management Plans (RMP) are a part of approval in the EU. Even in countries like Turkey, biosimilars can only be approved with a RMP and this is correlated with Genentech’s opinion, “Genentech believes that continued assessment of the product after approval is necessary”.