Compliance News / Compliance

EU Approves First Biosimilar Antibody Drug

Opportunity Grows for Follow-on Biologics

September 11, 2013

The European Commission has just approved the first biosimilar version of a monoclonal antibody drug. This is, at the most basic level, a generic version of a biologically active substance. This approval expands the opportunities for similar follow-on drugs, opening the biologics market much as generic medications expanded the market for chemical synthetic drugs in 1984.

The American company Hospira and its South Korean partner Celltrion received approval for its biosimilar drug, Inflectr™(infliximab), last June. Infelctra is approved to treat inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis. Hospira plans seek marketing approval in Japan later this year and in the U.S. in 2015.

Although the EU already has approved approximately 14 biosimilar drugs, this is the first anti-body based drug. The early approvals were for filgrastim (a granylocyte colony stimulating factor), epoetin (a human erythropoietin) and somatropin (a human growth hormone).

“For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra, and for the future of biologic therapy," says Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.

A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic. Remicade, the innovator product upon which Inflectra is based, recorded European sales of over $2 billion in 2012 for developers Johnson & Johnson and Merck & Co.

 An approval process for biosimilars in the U.S. was signed into law in 2010. Last week the California legislature passed Senate Bill 598, creating a pathway for the substitution of interchangeable biologic medicines within the state. "BIO is pleased that the California Legislature passed this legislation and continues to put patients first," comments Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO). 

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