Europe and Australia Reshuffle on Generics, Biosimilars

February 3, 2015

by Amanda Conschafter, blog editor

Europe and Australia are reassessing, recalling and reflecting on biosimilars and generic medications. The countries’ recent actions suggest that, despite pharmaceutical and regulatory advances, producing and regulating safe, effective follow-on medications remains a challenge.

Australia Nixes Biosimilar Naming Plans

Last month, Australia’s Therapeutic Goods Administration nixed plans to implement a new naming system for biosimilar medications. The announcement reflected the World Health Organization’s July 2014 proposal, “Biological Qualifier—An INN Proposal,” which suggests using a four-letter qualifier to distinguish biosimilars from their reference products. Australia had planned to use three-letter qualifiers.

The WHO says its proposed naming system seeks to avoid “separate and distinct national qualifier systems,” which could generate confusion. Australia’s Therapeutic Goods Administration plans to review its policy and consider how best to proceed.

EMA Recommends Halting Generic Drug Sales

Meantime, the European Medicines Agency (EMA) called a halt to the sale of certain generic medications. An EMA committee recommended pulling roughly four dozen generic drugs from the market because of flawed clinical tests conducted in India. This is not India’s first incident with faulty regulation.

The drugs in question treated hypertension, depression and diabetes, among other conditions. Several EU countries have already halted the drugs’ sales, though the U.S. Food and Drug Administration has not yet acted.

According to MedScape, the EMA’s recommendation stemmed from a French inspection of the medications’ biopharmaceutical manufacturer. The inspection revealed data manipulation over a five-year period, which cast suspicion on the company’s overall trials process and data integrity.

ECCO Poster Presentation Casts Doubt on Biosimilar’s Effectiveness

A European Crohn’s and Colitis Organisation poster presentation suggests that a rheumatoid arthritis biosimilar may not produce results comparable to those of its innovator biologic. The retrospective analysis compared data from two patient groups, one taking the brand-name infliximab and the second taking the biosimilar follow-on.

The study found that 29 percent of the patients taking the biosimilar required surgery, while none of the patients taking infliximab did. Likewise, 80 percent of patients taking the biosimilar needed to be re-hospitalized while only five percent of the infliximab patients did. Based on these and other data points, the researchers concluded that the biosimilar “may not be as efficacious as the reference medicine.”

Though thought-provoking, the research did not simultaneously compare two groups of randomly assigned participants as a traditional scientific study would; nor was it peer-reviewed. Comparisons of efficacy between biosimilars and biologics merit further study.

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