Patent litigation could hold up biosimilars

Eleven of the most promising biosimilars will create an estimated $250 billion in savings for U.S. payers, according to pharmacy benefits manager Express Scripts.

However, patent litigations could hold up the launch of two major biosimilars in the United States. In March, the FDA approved the biosimilar Zarxio (filgrastim-sndz) by Sandoz, which will compete with Amgen’s Neupogen (filgrastim), used to decrease rates of infection in certain cancer patients during chemotherapy. The drug produced $1.4 billion in sales last year.

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Another promising biosimilar in the pipeline is Hospira’s Inflectra (infliximab), a biosimilar to Janssen’s Remicade (infliximab), which may gain approval as early as June and would be the first monoclonal antibody biosimilar, according to Express Scripts. It could be indicated in all uses approved for Remicade, including rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. U.S. sales of Remicade totaled $4.5 billion last year.

These two biosimilars alone could create $22.7 billion in savings over their first decade of use, Express Scripts estimates.

Patent litigation disputes have been delaying the launch of Zarxio and are also expected to delay the launch of Inflectra, according to Aimee Tharaldson, PharmD, senior clinical pharmacist in Express Scripts’ Emerging Therapeutics department. “Biosimilar and reference biologic companies for both medications are involved in the ‘patent dance,’ ” Tharaldson said.

As part of the Biologics Price Competition and Innovation Act, which established an abbreviated pathway for the approval of biosimilars [351(k)], biosimilar manufacturers must turn over their biosimilar applications and other information – including the manufacturing process for the biosimilar – to the reference biologic manufacturer. “Biosimilar manufacturers of Zarxio and Inflectra have not yet turned over this information to Amgen and Janssen, respectively,” Tharaldson said.

While litigation among the companies is ongoing, it is possible that Zarxio will be launched by May 11 and Inflectra/Remsima will be approved and launched later this year, she added.

Additional biosimilars awaiting approval by the FDA this year include Celltrion/Hospira (Pfizer’s) biosimilar to Remicade, Apotex’s biosimilars to Amgen’s Neulasta (pegfilgrastim) and Neupogen (filgrastim), and Hospira (Pfizer’s) biosimilar to Epogen (epoetin alfa)/Procrit (epoetin alfa).

Some of the most promising 11 biosimilars, as identified by Express Scripts, include Avastin, Epogen, Herceptin, Humira, Intron A, Neulasta, Neupogen, Pegintron, Procrit, Remicade, and Rituxin.