Media Center

A decade of progress – and still just beginning

A Sandoz
opinion piece

By Carol Lynch
Carol Lynch is Global Head of Biopharmaceuticals and Chair of the European Biosimilars Group.

Looking back on the recent annual meeting of the European Biosimilars Group (EBG) in London, what strikes me most is how far we have come as an industry in 10 short years.

When we launched the first biosimilar in Europe in 2006, human growth hormone Omnitrope, and iPhones were still a year away from becoming reality. The progress since then has been impressive.

As of today, there are more than 20 registered biosimilars on the market in Europe, with market shares reaching 50 percent or more (filgrastim). Sandoz biosimilars alone have contributed more than 250 million patient days of safe clinical experience. Biosimilars overall have contributed significantly to increasing patient access across Europe and beyond, both by freeing up funds for healthcare systems through much-needed competition and by driving increases in overall biologic usage (e.g. the move to first-line use of filgrastim in the UK).

It’s a well-used phrase, but this industry really is at a tipping point. We are on the verge of substantial (possibly tenfold-plus) market growth over the next five years or so, as complex biosimilars open up new therapeutic possibilities in fields including immunology and oncology. At the same time, the massively important US market now has its first biosimilar (filgrastim) and is getting ready to emulate Europe. I’m sure the race will heat up very quickly!

Of course, we still face many challenges – commercial, legal and regulatory – and there is a lot of work to do to convince all concerned that biosimilars really are the wave of the future for patients and healthcare professionals worldwide.

I discussed a number of these challenges while I was at the EBG conference, both on stage and during an interview with leading trade publication Scrip. The key points I highlighted included the lack of a “one size fits all” approach to commercializing biosimilars, the need to deal with ongoing legal uncertainties in the US as we prepare for launches, and the importance of building acceptance for biosimilars amongst key stakeholders.


Panel discussion at Medicine for Europe’s EBG Biosimilars Conference 2016.

But, looking round me at the conference, I was convinced that we have what it takes to succeed. What I saw was a real collective interest in doing what is needed to help these wonderful new medicines deliver on their potential for patients and healthcare systems worldwide. I saw a genuine desire to engage in constructive dialogue, in order to find sustainable solutions that benefit all involved. I also saw ever-increasing interest in the space, with new companies showing up and participating actively.

And, finally, I realized that for anyone interested in the future of biosimilars, London really was “the place to be” at the end of April. Congratulations to the team at Medicines for Europe for organizing another great meeting – and I’m already looking forward to next year, by which time we should have made even more progress on increasing access to these critical medicines!