Will mAb biosimilars end the dry spell?
The approval of Celltrion’s infliximab version, dubbed Remsima by the European Medicines Agency (EMA), ”had reverberations everywhere,” says Jorge Santos Da Silva, a biosimilars expert and partner at business analyst McKinsey & Co. This success proved that biosimilar versions of complex molecules could also receive the go-ahead from some of the global market’s main regulators. “Infliximab is a very important molecule, especially for the treatment of rheumatoid arthritis and psoriasis. It is a multi-billion molecule that costs governments a lot of money,” says Da Silva. According to data from FirstView analysts, monoclonal antibody (mAb) biosimilars remain the dominant class when it comes to perceived commercial opportunities (30%), well ahead of runner-up Granulocyte-Colony Stimulating Factor biosimilars (G-CSF, 15%). Most big companies in the pharma space are now running a biosimilar programme.
Which mAb biosimilar will be next?
At the moment, 19 biosimilars are authorised in Europe, and 12 of them are on the market. The race to be the next mAb to shake the market is still on and many contenders have their eye on the multi-billion-euro oncology sector. Almost all of the marketed biosimilars authorised so far are ‘first-wave’ compounds – imitations of biological molecules with low molecular weights. Infliximab is the first compound from a second wave to make it through the regulatory surf. A third wave is already visible a couple of years down the road. It will be made up of biosimilars of active pharmaceutical ingredients (API) whose IP protection runs out in 2020 and beyond.
An uncertain environment
So just how big is the potential European market for biosimilars exactly? McKinsey’s Da Silva is cautious about former predictions that ranged from €2bn to €30bn by 2020: “It’s pretty clear that these numbers are achievable. But with all these uncertainties around, the question is – when do we hit it? In 2018, 2020 or 2025?” The uncertainties are largely due to the nature of the market. Biosimilar development is extremely difficult. Creating a protein that has the same molecular fingerprint as another means not only nailing down the right sequence of amino acids, but also the right conformation and modifications. And scientists admit that so far they don’t even know half of what they would like to know about the underlying molecular processes involved.