eChapter 2016: Goodman & Gilman Year in Review New and Noteworthy FDA Regulatory Actions

PART 3: BIOLOGICS

In 2016 the U.S. Food and Drug Administration (FDA) approved 22 new drugs and granted 32 noteworthy biologics licenses. Among the 22 new drugs are:

• Six pharmacological “firsts” (see Part 1);

• Three diagnostic imaging agents for use with PET imaging (see Part 1);

• Three previously unapproved marketed drugs (see Part 2);

• Two entities previously regulated only as a dietary supplements (see Part 2); and

• Eight new molecular entities that are pharmacologically similar to previously approved drugs (see Part 2)

Part 1 looked back at first-in-class drug approvals, breakthrough therapies and orphan indications, important new diagnostic tests, and novel medical devices. “Me-too” drug approvals and other 2016 FDA accomplishments were summarized in Part 2. Throughout the series, orphan, breakthrough, and cancer therapy designations are notated by the symbols †, $, and #, respectively.

The 32 noteworthy biologics approved in 2016 are described here. Among them are:

• Twelve new authorizations expanding the clinical uses for biologics that are already on the market in the United States:

  • Six are marketed biologics licensed for orphan indications, and one of these, ustekinumab (Stelara) ¹, an interleukin (IL)-12 and IL-23 antagonist, was also granted a new non-orphan indication to treat adults with Crohn’s disease;² (see Part 1)

  • Four are marketed biologics designated with breakthrough therapy indications; (see Part 1)

  • OnabotulinumtoxinA (Botox)³, a botulinum toxin—approval was extended to the treatment of lower-limb spasticity in adults

  • Secukinumab (Cosentyx)⁴, a monoclonal antibody that inhibits interleukin-17A—approval was extended to the treatment of active psoriatic arthritis and to the treatment of active ankylosing spondylitis (see also below)⁵

• Six first-to-market monoclonal antibodies⁶ (see eTable 7)

• Four new vaccines:

  • An oral cholera vaccine for travelers (see eTable 8)

  • Three new quadrivalent influenza vaccines (see eTable 8)

• Three biosimilars (adalimumab-atto,⁷ etanercept-szzs,⁸ infliximab-dyyb,⁹ see also below)

• Three recombinant coagulation factors (see eTable 8)

• Two new products derived from blood:

  • A fibrin coagulation patch (see eTable 8);

  • An immune globulin concentrate formulated for subcutaneous administration (see eTable 8)

• One previously marketed biologic approved for a new indication (daclizumab for multiple sclerosis)¹⁰

• A cellular sheet of chondrocytes for autologous implantation (MACI)

BIOSIMILARS

An interchangeable biological product is similar to an FDA-approved reference product and also meets additional federal standards for interchangeability. A pharmacist may substitute an interchangeable biological product for the reference product without preauthorization by the prescriber. In 2016 FDA approved three biosimilars. No biosimilars currently approved for use in the United States are approved as interchangeable.

1. Adalimumab-atto (Amjevita)¹¹—Humira¹² (not interchangeable)⁷

2. Etanercept-szzs (Erelzi)¹³—Enbrel¹⁴ biosimilar (not interchangeable)⁸

3. Infliximab-dyyb (Inflectra)¹⁵—Remicade¹⁶ (not interchangeable)⁹