Biosimilar Bytes

Samsung Bioepis’ Eticovo® cannot be marketed in the US until 2029, according to a New Jersey district court ruling. As reported in Big Molecule Watch, the court made a January 2020 temporary stay of marketing final, ruling for the plaintiffs Immunex and Roche. The court reaffirmed that Samsung Bioepis will not be able to sell its Enbrel® biosimilar in the US until the two patents at issue expire, on April 24, 2029. In other words, the landscape for biosimilar etanercept remains barren, and the likelihood of Enbrel’s makers having 30 years of exclusivity remains very high.

ICER says that AbbVie’s net price on Humira® increased 9.6% between 2019 and 2020, a bigger jump than its WAC price rise of 7.3%. The result was $1.34 billion more in US health expenditures. This was the largest dollar increase among pharmaceuticals in the nation. For the period 2017 to 2020, the net price of Humira has rocketed 29.6%, according to ICER. David Rind, MD, ICER’s Chief Medical Officer, pointed out that Humira has an “ever-escalating US price that contrasts starkly to its falling price in every country where Humira currently faces biosimilar competition.”

Viatris and Biocon announced the US launch of its interchangeable authorized biosimilar and branded versions of Semglee® insulin glargine-yfgn injections. In an email to BR&R, Viatris disclosed its launch wholesale acquisition cost (WAC) for the two differently packaged products: The WAC pricing of the nonbranded version is $147.98 per package of five 3-mL pens and $98.65 per 10-mL vial. This is 65% below the WAC for the reference agent Lantus®. In comparison, the WAC of the branded Semglee is $404.04 per package of five 3-mL pens and $269.38 per 10-mL vial (73% higher than the authorized generic). Viatris said that it will phase out the existing noninterchangeable Semglee (in other words, the old packaging) by the end of 2021.

Why would anyone choose the costlier version of Semglee? No doubt, to continue the flow of rebate dollars. The net cost is likely close for the two agents?

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