Year In Review: The Top-Five U.S. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016:

5. The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a biosimilar version of Amgen’s Neupogen® (filgrastim).  The first 2016 approval was Celltrion and Pfizer’s Inflectra® (infliximab), approved in April 2016 as a biosimilar version of Janssen’s Remicade®.  Inflectra® is the first biosimilar monoclonal antibody approved in the United States, and is indicated for the treatment of inflammatory conditions, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis. Earlier this month, Celltrion and Pfizer launched Inflectra®, with litigation pending in the District Court for the District of Massachusetts.  Notably, the only two biosimilars that are currently available in the U.S. market (Zarxio® and Inflectra®) were both launched prior to patent resolution.

4. The second biosimilar approved by the FDA this year was Sandoz’s Erelzi®, a biosimilar version of Amgen’s Enbrel® (etanercept).  Etanercept is a biologic therapeutic designed to mediate tumor necrosis factor receptor binding, which is implicated in a number of autoimmune diseases, including rheumatoid arthritis and psoriasis. Athough the FDA approved Erelzi® in August 2016, Sandoz has not yet launched its biosimliar product.  Litigation is pending in the District Court for the District of New Jersey.

3. The third biosimilar approved by the FDA this year is Amgen’s Amjevita®, a biosimilar version of AbbVie’s Humira® (adalimumab).  Adalimumab is a monoclonal antibody used to treat various forms of arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. The FDA approved Amgen’s biosimilar adalimumab product in September 2016. Amgen has not yet launched its biosimilar, which is currently the subject of pending litigation in the District Court for the District of Delaware. As we previously reported, Amgen has indicated that it may not launch before 2018.  Meanwhile, AbbVie reported growth in its sales of Humira® this year, with sales of $4.15 billion worldwide in the second quarter, a 17.4% increase over the same quarter in 2015.

2. Just last week, on December 15, Eli Lilly and Boehringer Ingelheim launched their insulin glargine injection product, Basaglar®, a follow-on biologic for Sanofi’s Lantus®.  Although Basaglar is approved as a biosimilar for Lantus® in Europe, in the United States, Basaglar® is not technically considered a biosimilar.  In the United States, Lantus® and other insulins are regulated under the Federal Food, Drug and Cosmetic Act like other drugs, and are not treated specifically as biological products under the Public Health Service Act, so they cannot act as the reference product for a biosimilar.  Because of this, Lantus® is licensed under an NDA, and Basaglar® was approved through the 505(b)(2) regulatory pathway for follow-on drugs instead of the 351(k) pathway for biosimilars.

1. Although the FDA still lags behind its European counterpart in number of approved biosimilar products, there are still many applications in the FDA pipeline, with several new applications accepted by the FDA in 2016.  In October 2016, the FDA accepted Coherus Bioscience’s application for a biosimilar version of Neulasta® (pegfilgrastim). Sandoz’s Zarxio® could face competition if the FDA approves Apotex’s Grastofil®, another biosimilar filgrastim. Likewise, Celltrion and Pfizer may face competition if the FDA approves Samsung and Merck’s proposed biosimilar infliximab. Hospira also seeks approval of Retacrit®, a biosimilar version of Amgen’s Epogen (epoetin alfa). If current trends continue, 2017 will be a watershed year for FDA approval and launches of biosimilars in the United States.

We wish you a happy and healthy holiday season, and a great start to the new year! We look forward to another exciting year of biosimilars deals and industry news in 2017!