Legal Battles Over the Biosimilars Patent Dance Continue in Amgen v Hospira

The ongoing district court litigation of Amgen v Hospira—a case regarding Hospira’s proposed biosimilar to epoetin alfa (Epogen), a biological agent used to treat anemia—progressed on May 26, 2017, when counsel for Amgen filed a motion for a preliminary injunction. As Big Molecule Watch reports, the motion seeks to keep Hospira from launching its new biosimilar until Hospira “has complied with the requirement of 42 U.S.C. § 262(l)(8)(A), which states that ‘[t]he subsection (k) applicant shall provide notice to [Amgen] not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).’”

Amgen’s motion follows on the heels of an FDA Advisory Committee’s recommendation on May 25, 2017, that the epoetin alfa biosimilar proposed by Pfizer (parent company to Hospira) be approved across all indications. In a press release, Pfizer representatives announced that the FDA’s Oncologic Drugs Advisory Committee had recommended approval of its biosimilar product, marking the first time that a biosimilar erythropoiesis-stimulating agent has been recommended for approval by such a committee.

Amgen v Hospira represents yet another legal battle in the so-called “patent-dance,” and joins the ongoing case of Amgen v Sandoz, which is currently being considered by the Supreme Court of the United States. At issue in Amgen v Sandoz is whether a biosimilar applicant is required by law to provide the reference product’s sponsor with a copy of its biologics license application and manufacturing information, and what recourse the reference product’s manufacturer has should the biosimilar applicant decline to provide those materials.

As Big Molecule Watch also reported, it is Sandoz’s position that, in legislation that stipulates that a biosimilar product manufacturer “shall” provide its application and marketing materials to the reference product’s sponsor, “shall” could be construed to mean that the applicant shall provide those materials only if it wishes to do so. Amgen, for its part, called Sandoz’s position a “surpassingly strange interpretation.”

The Supreme Court heard oral arguments in Amgen v Sandoz on April 26, 2017, and is expected to rule shortly. The Court’s decision in this case will have ripple effects throughout the industry, and may well affect the outcome of such ongoing cases as Amgen v Hospira by providing a clear judicial interpretation of the requirements for pre-marketing notice for biosimilar applicants.