Biosimilar Regulatory Roundup: July 2018

July 2018 was a banner month for biosimilars regulatory activity, both in terms of actions taken on individual products and in the wider context of the marketplace.

Among the highlights of the month was the FDA’s approval of its 12th biosimilar—and its second filgrastim biosimilar—Nivestym. The product, referencing Neupogen, is sponsored by Pfizer, which has not yet revealed a launch date.

Shortly after the approval, Pfizer’s corporate affairs global biosimilars lead, Juliana M. Reed, told The Center for Biosimilars^® in an interview that the company, as it continues to develop its portfolio of biosimilar products, hopes to see the market for these drugs become more accessible. She hailed the FDA’s Biosimilar Action Plan, newly unveiled by FDA Commissioner Scott Gottlieb, MD, as an encouraging step toward ensuring a competitive marketplace.

The plan, which will be the subject of a public hearing on September 4, focuses on improving the efficiency of the approval process, maximizing scientific and regulatory clarity for developers, developing effective communications to improve understanding of biosimilars, and supporting competition by reducing attempts to delay market entry of follow-on products (attempts which some state governments are taking the lead on curbing through legislation).

Notably, the plan also includes suggestions that the FDA will be working more closely with the Federal Trade Commission to rein in anticompetitive practices. Speaking to The Center for Biosimilars^® in an interview, Robert Cerwinski, JD, of Goodwin, said that he finds it interesting that the FDA is willing to be “a little bit more activist” in its approach to working with other regulatory bodies. “In the past, FDA has not always wanted to weigh in to such disputes,” he said.

Other stakeholders have voiced their thoughts on the plan as well, and while the agency’s vision has garnered broad support, some are waiting for specific deliverables; Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology’s (ACR) Government Affairs Committee, told the Center for Biosimilars^® in an email that “ACR along with other doctors hopes that the pathway for interchangeable drug approval will be finalized in all due haste.”

The FDA did deliver 1 promised document on the same date as the action plan—a final guidance for labeling biosimilars. The document pertains to prescribing information for non-interchangeable biosimilars.

Meanwhile, in Europe, multiple biosimilars have been the focus of regulatory action this month. The European Commission (EC) authorized 2 new biosimilar products: Sandoz’s adalimumab biosimilar, Hyrimoz, referencing Humira, and Pfizer’s trastuzumab biosimilar, Trazimera, referencing Herceptin.

Three additional biosimilars received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use, and will be forwarded to the EC for its final decision: Mylan’s adalimumab biosimilar, developed in conjunction with Fujifilm Kyowa Kirin Biologics, FKB327; Coherus’ pegfilgrastim biosimilar, CHS-1701; and Accord Healthcare’s pegfilgrastim biosimilar.

While the EMA has been busy with its regulatory duties, it also faces challenges in the days ahead, as the United Kingdom prepares to withdraw from the European Union and therefore from its membership in the EMA. This month, however, the UK Parliament voted to approve an amendment to the Trade Bill that would require the nation’s negotiating team to try to secure UK involvement in the EMA after Brexit. It is not yet clear whether the European Commission will consent to such an arrangement.