FDA Increases Number of Drug Approvals in 2017

In 2017, the FDA more than doubled the number of drugs it approved compared with the previous year, with 46 novel medicines receiving the FDA’s endorsement in 2017, according to Reuters.

The European Union also saw an increase in drug approvals, with 92 drugs receiving the green light in 2017, including generics, which were up from 81 in 2016.

Despite the increase in approvals, some of the world’s largest drug makers saw average returns in 2017, which reflects the competition of the industry as well as the growing share of new products being produced by younger biotech companies.

Consultancy company Deloitte said that the projected research and development returns at 12 of the world’s top drug makers were at an 8-year low at only 3.2% (down from 10.1% in 2010).

It is important to note, however, that the US drug approval tally for 2017 does not include the first of a new wave of cell and gene therapies from drug companies Novartis, Gilead Sciences, and Spark therapeutics, all approved in 2017 under a separate category.

Biosimilars also made an impact in the FDA’s bottom line for approved drugs in 2017:

• Infliximab-abda (Renflexis, made by Samsung Bioepsis—Merck, referenced on Remicade) gained FDA approval on April 21, 2017, for various inflammatory conditions, including Crohn disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA) (used in combination with methotrexate), ankylosing spondylitis (AS), psoriatic arthritis (PA), and plaque psoriasis (PS).
• Adalimumab-adbm (Cyltezo, made by Boehringer Ingelheim, referenced on Humira) was approved by the FDA on August 25, 2017 for subcutaneous use in patients with RA, juvenile idiopathic arthritis, PA, AS, UC, and PS.
• Bevacizumab-awwb (Mvasi, made by Amgen, referenced on Avastin) was approved on September 14, 2017 for treating patients with unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer, metastatic carcinoma of the colon or rectum, and metastatic renal cell carcinoma.
• Trastuzumab-dkst (Ogivri, Mylan—Biocon, referenced on Herceptin) was unanimously approved by the FDA on December 1, 2017 for all indications of the reference product, Herceptin.
• Infliximab-qbtx (Ixifi, sponsored by Pfizer, referenced on Remicade) was approved by the FDA on December 13, 2017 as a treatment for patients with RA, CD, pediatric CD, UC, AS, PA, and PS; however, since teh product gained approval, Pfizer has announced that it will not commercialize lxifi in the United States.

For 2018, drug makers have more new products waiting in the wings; however, the pace of FDA approvals may lag due to the fact that several drugs that were expected to be cleared in the first quarter of 2018 were actually approved in 2017.