European regulators this month approved a biologically similar version of an antibody-based drug for treating rheumatoid arthritis, in a move with global implications.

The decision opens the way for pharmaceutical companies looking to produce so-called “biosimilar” drugs for the treatment of complex diseases, effectively mimicking patented drugs worth billions of dollars. Analysts expect to see greater competition in the market for such biotechnology drugs, making treatment more widely available for patients around the world.

"Today's announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA, and provides the next step toward Inflectra being approved for use in Europe," Stan Bukofzer, Hospira's corporate vice president and chief medical officer, told reporters.

Although such biologic drugs have greatly improved the treatment of rheumatoid arthritis and inflammatory bowel disease, among other conditions, they have also drained the healthcare budgets of many countries, according to Richard Davies, another representative of the copycat manufacturer. "In a time when there is mounting pressure on health care budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards," said Davies.

The drug treats rheumatoid arthritis by targeting tumor necrosis factor alpha, a protein that helps cause the painful inflammation that plagues suffers of the condition, in addition to causing inflammatory bowel disease and plaque psoriasis. The drug's safety, efficacy, and tolerability were proven following a Phase III randomized, controlled clinical trial. Nearly three-quarters (73.4 percent) of patients who received the drug experienced a greater than 20 percent improvement in symptoms after 30 weeks using the injections or infusions. The drug was also shown to be as safe as its progenitor, Remicade.

Drug manufacturer Celltrion, of South Korea, plans to seek regulatory approval for Inflectra later this year in Japan and in the United States by 2015. Following the recommendation from the European Medicines Agency in June, the manufacturer will use U.S.-based Hospira to market the drug. Hospira said the new copycat drug would be distributed throughout Europe “at the earliest opportunity, taking into account any relevant patent protection.”

Essentially, the drug is a biosimilar copycat of Remicade, which is produced by Johnson & Johnson and Merck & Co. The drug is delivered by injection or infusion and, unlike drugs in pill form, has enjoyed a greater protection from generic copycat versions. However, European regulators on Tuesday made clear they’re receptive to greater competition.