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EMA trounces FDA in 2013 drug approval tally: 81 vs. 27


By Nuala Moran
Staff Writer

LONDON – The European Medicines Agency (EMA) outstripped the FDA in 2013, approving 81 drugs compared to the 27 approvals handed out by the FDA.

This was also a notable increase on 2012, when 57 products made it past the European regulator. However, the EMA also signaled that this upward trend will not continue, since it started work on only 79 new applications in 2013, down from 95 in 2012.

The figures for the EMA and the FDA are not strictly comparable, because the FDA numbers are for new molecular entities (NMEs), while the EMA includes 20 generics in its approvals list.

However, as a sign that innovation in the industry may be picking up, of the EMA’s 81 approved products, 38 contained a new active substance, up from 35 in 2012, 25 in 2011 and 15 in 2010.

The number of generics approved on the other hand was in line with 2012, and has been decreasing over the past few years.

The Committee for Medicinal Products for Human Use (CHMP), gave the thumbs down to seven products, of which two were approved subsequently. Eight applications were withdrawn before the CHMP pronounced an opinion.

As the pioneer in setting a regulatory pathway for biosimilars, the EMA might be expected to be busy on this front. However, there was a fall in the number of applications for this class of product in 2013, and only two were approved. The two were notable though, in being the first two biosimilar monoclonal antibodies to reach the market. They are Remsima, from Celltrion Healthcare, of Hungary, and Inflectra, belonging to Hospira UK Ltd., both biosimilar versions of Remicade (infliximab).

One important trick for gaining EMA approval is to seek scientific advice from the CHMP during development of a drug. Half of the companies whose products were approved last year received such advice, a move, the EMA said, “has been proven to significantly increase the probability of a positive outcome.” There was a 90 percent success rate for companies that sought advice, compared to 30 percent for those that did not.

While applications for biosimilar approvals have stalled, the number of approvals for rare disease treatments is steadily increasing, and reached 11 in 2013, against eight in 2012 and four in 2011. That demonstrates “the success of the European Orphan-medicinal product regulation, which came into force in 2000,” the EMA said.

The EMA also trumpeted two new approvals in 2013 via its Advanced Therapy Medicinal Products pathway, under which it assesses cell and gene therapies and regenerative medicines. This brings to four the number of products approved by that route.

The 2013 roster of EMA approvals also highlights the rise of targeted drugs for treating cancer. Off 16 approved oncology products most are considered to be targeted therapies, which block the growth and spread of tumors by inhibiting specific promoter molecules, or acting on the patient’s immune system.

In other therapeutic areas, the EMA singles out positive recommendations for three new treatments for multidrug-resistant tuberculosis, four new HIV drugs, all containing a new active substance, and five new diabetes drugs.

Of the 27 NMEs approved by the FDA in 2013, only two were biologics, Gazyva (obinutuzumab) and Kadcyla (ado-trastuzumab emtansine), both developed by the Roche AG subsidiary, Genetech Inc.

The number of biologic NMEs approved was down from nine in 2012 and six in each of the previous three years. (See BioWorld Today, Jan. 17, 2014.)