Infliximab Biosimilars Launch in Europe. (So What?)

Infliximab is a so-called TNF-Blocker, also known as a TNF-α inhibitor (TNFi), [[{"type":"media","view_mode":"media_crop","fid":"32313","attributes":{"alt":"biosimilars","class":"media-image media-image-right","id":"media_crop_8307836061282","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"3420","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"width: 142px; height: 124px; float: right; margin: 3px;","title":" ","typeof":"foaf:Image"}}]]i.e. a monoclonal antibody directed against tumor necrosis factor α. Infiximab is a chimeric monoclonal antibody; i.e. there are foreign proteins in the molecule. I have used this drug for 15 years and I also carried out research studies using it about 15 years ago.

In the European Union (EU), infliximab is approved for various inflammatory-rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and other inflammatory dermatologic disorders including psoriasis.

So-called biosimilars of this drug were also approved in the EU at the beginning of this week. Biosimilars are me-too products similar to biotechnologically created proteins, for example a monoclonal antibody like inflximab, that have been approved after the patent for the original product has lapsed. Unlike chemically created generic medications, the biosimilar molecule is not identical to the original product. It is merely similar.

Why is this happening? Because it is lucrative business. It has to do with the much-sought-after millions of Euros in the market.

At the beginning of this week Inflektra (Hospira) and Remsina (Mundipharma) were approved and are also marketed and advertised. And that’s where it goes against the grain for me.

“Inflektra™ - the first biosimilar with the active substance of Infliximab/New perspectives for a better future in gastroenterology, rheumatology, and dermatology.”

What will this new perspective be? Another firm will earn money. The active substance cannot offer more than Infliximab.

“Remsima® / German doctors enjoy the first Infliximab alternative.”

Really, all German doctors? Only a limited number of them prescribe Infliximab, because it is more complicated than other medications and because it is very expensive.

Probably insurance companies, politicians, and also Germany’s doctors hope for a rollback of the high-priced segment of biologics.

We haven’t yet seen any prices, but I have to believe that the original manufacturer can endure a price reduction better than the successor, which needs to earn back its investment.

Medically, biosimilars offer absolutely nothing. Will they achieve any economic benefit? Thatremains to be seen.

(Translated and reprinted with permission from "Infliximab - Biosimilars,"posted February 19, 2015 on Dr. Kirsch's blog, "Rheumatologe".)