2016 proved to be less than stellar for pharmaceutical companies for a number of reasons, not least being a low point for marketing approval of new products (22 in 2016). While the industry continues to shift the focus of R&D efforts towards compounds that carve a niche in rare or specialty diseases, industry leaders hope the turn of the new year and new administration will reverse the downward trend.
Decline in approval of NMEs. New molecular entities (NMEs) comprised only 25% of all approvals seen in the last year with the majority of approvals aimed at new formulations or new dosages of existing drugs. This strategy seems to indicate an effort to stave off potential competition in the coming years by generic competitors. Data released by the FDA indicates that the year closed with 22 approvals for NMEs compared with 45 in 2015 and 41 in 2014. In addition, 12 NMEs received complete response letters, however most were related to manufacturing issues and did not indicate a need for more clinical data.
Biosimilars continue to stagger in the US market. The last year saw 3 new biosimilar products approved by FDA. Inflectra, Erelzi, and Amjevita are all biosimilars referencing monoclonal anti-bodies (mABs) that are indicated for a wide variety of inflammatory diseases, notably rheumatoid arthritis. Of these, Amjevita, a biosimilar to Humira (adalimumab), gears up to threaten sales of the blockbuster drug despite the latter filing almost 70 new patents covering formulations, manufacturing process, and indications in a last ditch effort to undermine generic competition.
Approvals in Oncology lag behind other therapeutic areas. Data shows most approvals in 2016 were for products treating infectious diseases, CNS disorders, and rare diseases. Despite the new wave of technological breakthroughs in cancer research, the pace of approvals for compounds in oncology lagged significantly behind other categories
Cautious Optimism for 2017. With the advent of a new Administration and the recent passage of the 21st Century Cures Act, the industry hopes that this year will be recorded as an outlier, rather than a harbinger of a more challenging environment to come.