Constance A. Wilkinson, Member of the Firm in the Litigation and Health Care & Life Sciences practices, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Health & Business, in “Stelara Biosimilar Tests Market Impact of Drug Price Program,” by Nyah Phengsitthy. (Read the full version – subscription required.)

Following is an excerpt:

The Biden administration’s implementation of the Medicare drug pricing program could alter drugmaker strategy on biosimilars, highlighted by the recent approval of a follow-on biologic to a Johnson & Johnson drug tapped for negotiations.

The FDA’s approval last month of Amgen’s Wezlana as an interchangeable biosimilar to Johnson & Johnson’s Stelara raised the possibility that the drug to treat multiple inflammatory diseases could be pulled from the price negotiation program put in place by the 2022 Inflation Reduction Act.

Stelara is the first instance of a drug on the price negotiation list with an approved biosimilar expected to hit the market, but it’s unlikely to be the last. Other biologics on the list such as Amgen’s Enbrel, used to treat rheumatoid arthritis, and Novo Nordisk’s NovoLog and Fiasp insulins are expected to have a biosimilar enter soon as well.

Prior to the Centers for Medicare & Medicaid Services’ selection of drugs for price cuts, drugmakers were already uncertain about future entry for biosimilars due to the provisions the program imposed. The potential value of a biosimilar entering the market may be eroded if Medicare can significantly lower the price of a biologic.

Amgen’s Wezlana is a test case for this “widely held premise,” said Connie Wilkinson, an attorney at Epstein Becker Green and member of its board of directors.

“The erosion of the value proposition may impact not only this biosimilar but others, which could result in them being withdrawn from the market or never launching,” Wilkinson said. “These dynamics are expected to significantly undercut incentives for developing biosimilars with high utilization in the Medicare market.” …

Open or Closed Doors

Under the law, biosimilars are affected in three key ways: a temporary payment increase for qualifying biosimilars under Medicare Part B; Part D reforms and rebates; and the drug price negotiation program. The law allows biologics to be negotiated 11 years after the Food and Drug Administration’s approval, unless a biosimilar competitor is available and marketed. …

If the CMS is successful in negotiating a significantly lower maximum fair price for Stelara, “it would exacerbate for Wezlana the market access issues biosimilars already face, given that a less expensive reference product makes a biosimilar look less favorable to purchasers,” Wilkinson said.

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