Radar on Specialty Pharmacy

Oct. 30: The FDA gave an additional approval to Bristol Myers Squibb’s Orencia (abatacept) for the subcutaneous treatment of people at least 2 years old with active psoriatic arthritis. The agency first approved the selective T cell costimulation modulator on Dec. 23, 2005. Dosing for the newest use is 50 mg once weekly for people with a body weight of 10 kg to less than 25 kg, 87.5 mg for those with a body weight of 25 kg to less than 50 kg and 125 mg for those with a body weight of at least 50 kg. The agent also is approved for intravenous dosing of certain indications. GoodRx lists one carton of four 125 mg/mL single-dose syringes as more than $5,520.

Oct. 31: The FDA expanded the approval of Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on Dec. 13, 2022. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The price of two single-dose prefilled pens or two single-dose prefilled glass syringes is $6,576.   

On March 23, 2010, then-President Barack Obama signed the Affordable Care Act (ACA) into law, establishing the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. At the same time, the change may help promote uptake of biosimilars, bringing cost savings to the U.S. health care system, say industry sources.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA). However, the drug’s lack of an additional formulation may hurt its uptake, say industry sources.

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.