Biosimilar Bytes This Week

The Institute for Clinical and Economic Review (ICER) released a report this week that highlighted seven pharmaceuticals with “substantial price increases on top of already high current spending.” According to ICER, these seven agents accounted for billions in unnecessary expense in 2017 and 2018. AbbVie’s Humira® and Genentech’s Rituxan® topped the list, with Neulasta® coming in at number 5. The first two are not that surprising, because relatively high price increases (even net rebates or other considerations) are common reactions of pharma companies to imminent new competition. This has been typical for small molecule brands facing patent expiration and generic challenges. In 2017 and 2018, AbbVie may have been more concerned that it could not reach a settlement with the several biosimilar manufacturers working on adalimumab agents. Genentech also faced similar conditions with Rituxan. On the other hand, Amgen was already facing strong competition from Zarxio® and Granix®.

ICER specified,Net price increases for the seven drugs unsupported by new evidence were responsible for increasing total US drug spending by more than $5.1 billion from 2017 to 2018. The drug whose price increases accounted for the greatest single impact on spending was Humira. Humira’s average US price increased 15.9% over this period.I emphasize, this was net price not list price increases.

In a presentation at the Drug Information Association (DIA) annual meeting, Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, stated that 83 biosimilar development programs were now ongoing, for a total of 38 different biologics. This implies that biosimilar interest in several new classes of biologics remains strong from established and prospective manufacturers.

Tanvex BioPharma announced in late September that its TX-01 filgrastim biosimilar candidate was not approved by the FDA. According to Tanvex, the FDA’s complete response letter did not cite any data deficiencies that might require additional studies. This leads one to suspect that production facilities problems may be the issue. The soonest Tanvex can expect a new FDA decision is 6 months from its new application submission date. As a result, Zarxio® and Nevistym® remain the only two biosimilar filgrastim agents (plus the follow-on product Granix®) to compete with Amgen’s Neupogen.

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