What's Next in the Drug Pipeline?

Expiring patents of brand name drugs have paved the way for increased competition in the year ahead.

The year 2016 is shaping up to be a big year for FDA drug approvals, with an estimated $20 billion targeted for generic treatments, according to the annual Express Scripts Drug Trend Report.

Numerous name brand drugs such as Gleevec, Crestor, Benicar and Benicar HCT, Seroquel XR, and Zetia have expiring patents that pave the way for new competition to enter the market.

Below are the top drugs in the pipeline either expected to be approved or have the chance to gain approval this year.

Drugs Expected to Gain Approval in 2016

  • Atezolizumab (Genentech) — A drug created for the treatment of non-small cell lung cancer (NSCLC) and bladder cancer
  • Entinostat (Syndax Pharmaceuticals) — A drug taken orally for certain types of breast cancer
  • Venetoclax (AbbVie/Genentech) — Oral drug for patients with chronic lymphocytic leukemia.
  • Sofosbuvir/velpatasvir — a tablet for the treatment of hepatitis C genotypes 1 through 6

Drugs That Could Gain Approval in 2016

  • Infliximab (Remicade) — a monoclonal antibody biosimilar used for the treatment of rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. The biosimilar could gain approval as early as June for a drug that totaled $4.5 billion last year.​
  • Etanercept (Enbrel) — used for the treatment of immunological diseases such as rheumatoid arthritis and psoriasis. Enbrel could gain approval as early as June.
  • Adalimumab (Humira) — an alternate treatment for patients with moderate-to-severe plaque psoriasis and rheumatoid arthritis, with an FDA action date in September.
  • Lyxumia, Lixilan, Xultophy, Basaglar — these 4 drugs that are used to treat type 2 diabetes may gain FDA approval this year.