Alvogen launches Inflectra into Central and Eastern Europe

Alvogen, the multinational pharmaceuticals company, today announced the launch of Inflectra™ (Infliximab) into Central and Eastern Europe. Inflectra^TM, Europe's first biosimilar monoclonal antibody (mAb) therapy that has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis. Alvogen and Hospira formed a strategic partnership in 2011 to provide the highest quality products and services for customers and patients throughout Central and Eastern Europe (CEE). This alliance enables us to provide increased access to the newest biosimilar drugs with state-of-the-art technology.

Inflectra^TM is a biosimilar medicine to the reference medicinal product, Remicade^TM (Infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. Remicade^TM recorded European sales of over USD 2 billion in 2012. Alvogen will market the product in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, and Romania.

Petar Vazharov, Executive Vice President at Alvogen in the CEE region, commented: "We are delighted about the launch of Inflectra^TM. 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^TM we demonstrate the continued growth we are achieving in this important portfolio. Inflectra^TM offers a more affordable - but equally effective - treatment option for sufferers of inflammatory conditions, offering compelling cost saving opportunities within the European Union."

Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer of Hospira added: "The rigorous scientific review conducted by the European Medicines Agency and approval by the European Commission confirms that Inflectra^TM has demonstrated similar quality, efficacy and safety to Remicade^TM. For over a decade, biologic medicines have been pivotal in treating a range of inflammatory conditions, so the launch in Europe of Inflectra^TM as a biosimilar alternative represents a huge step towards the affordability of future biologic therapies."

The use of biologic medicines has led to vast improvements in the efficient treatment of conditions such as RA and IBD (inflammatory bowel disease), but these drugs are also responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to €20.4 billion by 2020.

In partnership with Hospira, Alvogen has been marketing biosimilars in Central & Eastern Europe for a number of years, with great success. Partnering with Hospira gives Alvogen access to a well established biosimilar pipeline. Hospira's biosimilar portfolio includes Inflectra™ as well as two other currently marketed products in the areas of nephrology and oncology. In addition, Hospira plans to launch a number of new biosimilar monoclonal antibodies, one of which is currently in late stage development. Together, Alvogen and Hospira share the commitment to deliver the highest quality products and services to its customers and patients.

Demonstrating its ongoing commitment to the exciting biosimilar market, Alvogen's sister company, Alvotech, announced in November 2013 that it would invest $250 million in biopharmaceuticals. This investment includes the building of a state-of-the-art biopharmaceutical development and manufacturing center in Reykjavik, Iceland and a pipeline including six monoclonal antibodies.