At the beginning of 2014 there was some consternation that the FDA's approval rate of novel pharmaceutical and biologic products – the most frequently cited barometer of industry productivity – had demonstrated a notable year-on-year decline; the administration approved 33 new products in 2013 versus 43 in 2012.
The 'quality' of the class of 2013 has never been in doubt, however. Each of the 10 largest growth drivers – based on consensus sales in 2018 – is expected to become blockbuster products within five years of approval. By FirstWord's estimations, using consensus data sourced from Bloomberg, these 10 products are expected to generate combined global sales of $34 billion by 2018.
By comparison, the 10 largest growth drivers approved in 2012 are expected to generate combined sales of around $15 billion by 2017 (five years post-approval).
Can the momentum provided by 2013's novel launches be maintained?
This year has already seen a handful of products approved by the FDA for which consensus forecasts indicate blockbuster status by 2019; these include Celgene's Otezla for psoriatic arthritis, AstraZeneca's Farxiga for diabetes and Eli Lilly's Cyramza for stomach cancer.
Key regulatory action is likely to occur over the next six to 12 months, however, and will see the December 2013 approval of Gilead Sciences' hepatitis C treatment Sovaldi – which is currently demonstrating the strongest new drug launch of all time – enhanced by an anticipated October approval for the company's fixed-dose combination of Sovaldi and ledipasvir.
AbbVie's all-oral hepatitis C regimen also has a December PDUFA and is forecast to generate 2019 sales of $2.5 billion, while Bristol-Myers Squibb's daclatasvir and asunaprevir compounds are expected to gain approval at a similar time.