To say 2013 was not a banner year for novel biologic approvals would be an understatement.

The FDA approved 27 new molecular entities (NMEs) last year, but only two were biologics – Gazyva (obinutuzumab) and Kadcyla (ado-trastuzumab emtansine). Both were developed by the same company, Roche AG subsidiary Genentech Inc.

While NME approvals as a whole were about average, the number of biologic NMEs approved was down from nine in 2012 and six each in 2009, 2010 and 2011. Even in 2008, which was considered a bad year for biotech, the FDA approved three biologic NMEs. (See BioWorld Today, Nov. 7, 2011, and BioWorld Insight, Dec. 10, 2012.)

Obviously, the number of NMEs approved each year depends on the number of applications the FDA receives. But there was no dearth of biologic NMEs submitted last year; 12 of the 36 NME applications the FDA received were for biologics, an agency spokesman told BioWorld Today.

Because FDA review can take several months, applications received in one year may not be approved until the following year. Thus, comparisons of approvals to applications in each year don’t align directly. Depending on when they were filed, several of the 12 biologic applications submitted last year may still be under review, which could bode for a bumper number of biologic NME approvals this year.

The agency cautioned that the 2013 figures are preliminary, as some of the applications may not have been formally accepted for filing as of the date of the report the FDA released Wednesday.

In comparison, the FDA received seven biologic NME applications in 2008 and again in 2009 and only four in 2010. The numbers for 2011 and 2012 weren’t available, since the agency doesn’t routinely differentiate between drug and biologic NMEs in its reports.

Overall, the number of NME approvals and applications submitted in 2013 were down considerably from 2012, when the FDA received 41 applications and approved 39 NMEs. But in the report, the agency characterized the 2013 numbers as about average when compared with approvals and applications for the past 10 years.

The trend has been consistent and steady from 2004-2013, the agency said. Until that changes, there will be no big increases in the number of new drug and biologic approvals, it warned.

However, when the first half of that time span is compared with the last five years, an upward trend is noticeable in both applications and approvals. From 2004-2008, the agency received 165 NME applications, for an average of 33 per year. The number of applications received from 2009-2013 increased 7 percent to 177, averaging more than 35 per year.

The jump is even more dramatic with approvals. From 2004-2008, the FDA approved 116 NMEs, averaging 23 per year. From 2009-2013, it approved 143 NMEs, averaging nearly 29 per year. That’s a 23 percent increase.

Put another way, NMEs submitted between 2004-2008 had about a 70 percent approval rate, whereas those submitted from 2009-2013 had nearly an 81 percent approval rate.

MORE THAN NUMBERS

While the numbers may be interesting, the FDA said the significance of the NMEs approved in 2013 is more important than the quantity. A third of the newly approved NMEs were first in class, and a third were approved to treat orphan diseases (some of the drugs fall in both categories).

Nearly half of the approved NMEs received some form of expedited approval, and about 75 percent were approved in the U.S. before being approved elsewhere. The FDA approved every NME by its PDUFA date, with 89 percent of the drugs being approved on the first cycle of review.

Both biologic NMEs, which had been granted priority review and orphan designation, were approved on the first cycle. Kadcyla – an antibody drug conjugate that pairs Roche’s Herceptin (trastuzumab) with Immunogen Inc.’s DM1 maytanisinoid cell-killing agent – was approved in February 2013 as a first-in-class biologic. It was given fast-track status as it addresses an unmet need in treating patients with HER2-positive, late-stage breast cancer. (See BioWorld Today, Feb. 25, 2013.)

Developed through a partnership with Biogen Idec Inc., Gazyva was the first drug approved through the FDA’s breakthrough therapy designation. It was approved in November 2013 to be used in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia. (See BioWorld Today, Nov. 3, 2008, and Nov. 2, 2013.)