Rise of the biosimilars in the United States

Novartis’ Sandoz business launched Zarxio, the first U.S. biosimilar, during September 2015 as a copycat version of Amgen’s blockbuster neutropenia drug Neupogen (filgrastim). As of early October 2015, Sandoz intended to make 10 regulatory submissions within a three-year period. At that time, the company announced that the FDA had accepted the Sandoz regulatory submission for biosimilar Enbrel (etanercept). Sandoz is seeking approval for all indications included in the label of the blockbuster reference product from Amgen, a TNF-alpha inhibitor, including rheumatoid arthritis and psoriasis.

In November 2015, the FDA accepted the Biologics License Application (under the 351 (k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF). The proposed biosimilar pegfilgrastim filing is the second of the 10 regulatory submissions planned for the 2015-2017 period.

Inflectra became the second FDA biosimilar approval in April 2016. The biosimilar represents a cheaper version of Johnson & Johnson’s megabrand Remicade (infliximab) for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis, and arthritis of the spine. Inflectra is manufactured by South Korea’s Celltrion in partnership with Pfizer’s Hospira business. The drug was approved by EU regulators during 2013 and was launched in Europe’s largest countries in February 2015. Inflectra reportedly gained more than 20 percent share of the Remicade market in terms of patient numbers in European countries where the copy is sold as of December 2015.

Leading biotech company Amgen has been actively attempting to protect its product patents for the likes of Enbrel, Neulasta, and others from biosimilar threats. A U.S. court rejected Amgen’s appeals to block U.S. sales of Zarxio. Amgen also went the U.S. court route to fend off biosimilar competition from Sandoz and Hospira for the anemia drug Epogen.

Meanwhile, Amgen also is challenging the patents of other manufacturers to develop its own biosimilars for launch as early as 2017. The company’s most advanced candidate is ABP 501, a biosimilar for the blockbuster anti-inflammatory treatment Humira (adalimumab) from AbbVie. During 2015, U.S. patent officials denied Amgen’s petitions to review patents on Humira, thus slowing down Amgen’s development of its biosimilar version.

IMS analysis revealed during March that lower-cost copies of complex biotechnology drugs could save the United States and Europe’s five top markets as much as €98 billion ($110 billion) by 2020. Realizing those savings, however, depends on effective doctor education and healthcare providers adopting smart market access strategies, according to the report by IMS Institute for Healthcare Informatics. The savings of €98 billion is based on eight major branded biotech drugs, including AbbVie’s Humira and Roche’s Herceptin, that are on track to lose patent protection during the next five years. The amount additionally assumes an average biosimilar price discount of 40 percent, and savings would fall to €74 billion at a 30 percent discount and €49 billion at 20 percent. The IMS forecast includes Germany, France, Italy, Britain, Spain, and the United States.