The FDA OKs 5 blockbusters in slow start to 2013 drug approvals

Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.

But it's not as bad as it may appear at first glance.

Back in 2012, the FDA had approved 14 new drugs at the halfway mark, about where we are now. Last year at this point Fitch Ratings was fretting that the pace, behind the 18 new approvals for H1 2011, meant the industry could be headed for a dismal performance. Instead, a strong second half pushed new approvals to 39--the best record in 16 years and a marked improvement on the 32 approvals recorded in 2011.

The new approvals, tabulated by Nature, include Genentech's Kadcyla (T-DM1) for metastatic breast cancer, as well as Biogen Idec's ($BIIB) Tecfidera (BG-12), J&J's ($JNJ) Invokana (canagliflozin) and three drugs for GlaxoSmithKline ($GSK), which needs to rack up some R&D successes after some lean years.

Pfizer's ($PFE) former R&D chief John LaMattina told FirstWord Pharma that the FDA typically does most of its new drug approvals in the second half of the year, and 2013 was still shaping up as a solid year for biopharma on the regulatory front. There's also a wild card to consider this year, with the FDA eager to prove that it means business when it comes to the new breakthrough drug designation, raising the prospect of some early approvals for some key programs.

Earlier this year Fitch was at it again, though, predicting a downturn in new approvals, despite a surge in OKs for cancer and diabetes drugs.

Based on FirstWord's estimates on sales potential, here are the top 5 blockbuster drugs so far this year, as measured in 2018 sales:

  • Tecfidera (multiple sclerosis): $4.2 billion
  • Kadcyla (breast cancer): $2.9 billion
  • Breo Ellipta (COPD): $1.84 billion
  • Pomalyst (multiple myeloma): $1.28 billion
  • Nesina (diabetes): $1.1 billion

- here's the story from FirstWord Pharma
- see the list of H1 drug approvals from Nature

Slideshow: FDA Approvals of 2012