The potential benefits of biosimilars are too big for players to ignore, with biologicals accounting for many of the molecules soon to come off patent. “The future is bright, and companies are confident they will get into this area,” Dr Suzette Kox, the EGA's Director of Scientific Affairs told Scrip.

“Within three years there should be more progress, but there is still more work to be done, particularly in disseminating information about biosimilars,” she said. So far the biggest hurdles have come not from regulatory challenges, but from originators spreading misinformation about the interchangeability, safety and quality of these products.

“Inroads have already been made. The argument that the advanced technologies used to manufacture biosimilars mean fewer impurities in the finished product is gaining ground,” said Dr Kox. Meanwhile, the sector is also gaining momentum in Germany where all somatropins, including biosimilars, are in the same reference pricing group.

Separately, Dr Gerard Van Odijk, President and CEO of Teva Pharmaceuticals Europe, commented that Germany was just the first run and that the big money was still to come when the bigger molecules came off patent.

At the 7th EGA Symposium on Biosimilar Medicines earlier this year held in London, UK, Dr Kox had explained that “the applicability of the biosimilarity concept to monoclonal antibodies is triggering great interest. Highly sophisticated analytical and validation tools are available today to assist in the characterisation of mAbs. In addition, modern manufacturing technologies allow the consistent production of recombinant proteins with highly specific predefined quality characteristics. Our industry is definitely taking up this new challenge.”