In order to put one biosimilar into the market, the manufacturer has to show its detailed structure and functional characteristics as well as toxicity data of animal experiment, and also possess clinical research data of comparing immunogenicity with pharmacokinetics/pharmacodynamics, to prove that the product is very similar to or completely consistent with its reference drug, and the product is safe and effective. Biosimilars can save costs for patients, the government or insurance companies, for example, the cost of generic drug of erythropoietin can be reduced by 35%-50%.
2013 was the most glorious year for biosimilars, whose iconic event was that Celltrion Company and Hospira Company launched generic drug of infliximab in European market. By contrast, the launch momentum of biosimilars in 2014 returned to the "normal" level, wherein, some products were below expectation.
Launch of generic drug of infliximab in European market in 2014 raised concern of the industry, for which there were many reasons. For example, it was the first time that biosimilar of polyclonal antibody type had been launched in European market, and it also reflected the positive attitude of EMA to obtaining indications of generic drug through extrapolation method. Other indications did not require proving actually. However, the generic drugs of Celltrion Company and Hospira Company can only be temporarily launched in markets of several small European countries due to the dispute of intellectual property, meaning that the prospect of biosimilars of monoclonal antibody is still not optimistic in Europe.
