US-based specialty pharmaceutical firm Alvogen has launched a biosimilar monoclonal antibody (mAb) therapy ‘Inflectra (Infliximab)’ in Central and Eastern Europe.
Inflectra is a biosimilar medicine to the reference medicinal product ‘Remicade (Infliximab)’. It is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway.
The drug has been approved to treat inflammatory conditions, including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.
Alvogen and Hospira have marketed biosimilar drugs throughout Central and Eastern Europe (CEE) since establishing their partnership in 2011, which also allows them to provide increased access to the newest biosimilar drugs with best technology.
The product will be marketed by Alvogen in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, and Romania.
Alvogen executive vice-president in the CEE region Petar Vazharov said: "This product represents a major milestone for our biosimilar portfolio, which has been making great progress since its launch in partnership with Hospira in 2011.
"Biosimilars offer a huge opportunity for our business in Eastern Europe and with Inflectra we demonstrate the continued growth we are achieving in this important portfolio.
"Inflectra offers a more affordable, but equally effective, treatment option for sufferers of inflammatory conditions, offering compelling cost-saving opportunities within the European Union."
The vast improvements in the efficient treatment of conditions such as RA and IBD (inflammatory bowel disease) are because of the use of biologic medicines, but these drugs also account for some of the highest medicinal costs in many countries.
If the biosimilar mAbs are introduced in Europe they are expected to deliver savings of up to €20.4bn by 2020.
Hospira corporate vice-president and chief medical officer Stan Bukofzer said: "For over a decade, biologic medicines have been pivotal in treating a range of inflammatory conditions, so the launch in Europe of Inflectra as a biosimilar alternative represents a huge step towards the affordability of future biologic therapies."
Biosimilar portfolio of Hospira comprises of Inflectra and two other marketed products in nephrology and oncology.
In addition, Hospira intends to launch a number of new biosimilar monoclonal antibodies, with one currently in late-stage development.
Image: High-magnification micrograph of Crohn’s disease. Photo: courtesy of Nephron.