Alvogen said today it launched a biosimilar version of the Johnson & Johnson/Merck & Co. blockbuster arthritis drug Remicade™ (Infliximab) into Central and Eastern Europe, through its three-year-old partnership in those regions with Hospira.
Inflectra™ will be marketed by Alvogen in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, and Romania. Europe’s largest markets, however, are unlikely to see that biosimilar, and another Remicade copy by Celltrion, begin commercial sales until February 2015, when patents for those areas of the continent expire.
A tumor necrosis factor α (TNF-α) antagonist, Inflectra is the first biosimilar monoclonal antibody (mAb) therapy approved for the continent through the European Medicines Agency (EMA) biosimilars regulatory pathway.
Inflectra is indicated for inflammatory conditions that include rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA), and psoriasis.
“Inflectra offers a more affordable—but equally effective—treatment option for sufferers of inflammatory conditions, offering compelling cost saving opportunities within the European Union," Petar Vazharov, Alvogen’s evp for Central and Eastern Europe, said in a statement.
Inflectra will be priced at a 39% discount to Remicade in Norway, regulators there disclosed late last month, based on results of that nation’s central tendering process for buying medicines used in hospitals.
Alvogen and Hospira have marketed biosimilar drugs in Central and Eastern Europe since forming their partnership in 2011. Hospira’s biosimilar portfolio includes Inflectra and two other marketed products in nephrology and oncology. According to Alvogen, Hospira also plans to launch a number of new biosimilar monoclonal antibodies, including one that is now in late stages of development.
Alvogen’s sister company Alvotech said late last year it will spend $250 million to develop and manufacture biosimilar monoclonal antibodies, expanding a portfolio of biosimilar mAb molecules the company plans to bring to market by 2018. The initiative includes construction of a new 11,800 square meter (about 127,000 square feet), fully vertically integrated biologics development and manufacturing facility, set to open in early 2016 at the science park of the University of Iceland in Reykjavik.
Alvogen was one of two companies to win European approval last year for biosimilar versions of Remicade. The other was Korea’s Celltrion, which has said it plans to launch its Remicade copy called CT-P13 this year.
Remicade is Johnson & Johnson’s best-selling drug, with its share of sales rising 8.6% last year compared with 2012, to $3.891 billion—including a 13.8% year-over-year sales jump during the fourth quarter of 2013, to $1.712 billion. Merck's portion of Remicade sales increased 7% year-over-year during 2013, to $2.271 billion, including $620 million racked up during Q4, up 13% from fourth quarter 2012.
While the drug’s patents for the largest European markets expire next year, Remicade remains patent-protected in the United States until 2018.