Radar on Specialty Pharmacy
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In 2024, FDA Approved Innovative Treatments for Several Complex Diseases
While the FDA’s 44 novel drug approvals as of Dec. 11 may have been lower than 2023’s 55, the agency still green-lighted some impressive agents. Among those were the first agent for a liver disease that can have serious complications; the most expensive gene therapy ever, which was approved for a disease that shortens lifespans, particularly among children; and a first-in-class therapy for a solid tumor. The agency also granted additional indications to already-available treatments, including several chimeric antigen receptor T cell (CAR-T) therapies. Industry experts spoke with AIS Health about some of the top FDA approvals of 2024. (Editor’s note: These comments have been edited for length and clarity.)
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FDA Approved 18 New Biosimilars This Year, Impacting 2024 Market Dynamics
In 2024, the FDA almost doubled its previous annual highest number of biosimilar approvals, besting 2019’s 10 by green-lighting an additional eight agents and bringing the total approved since 2015 to 63. Arguably the biggest story was that biosimilars of AbbVie Inc.’s best-selling Humira (adalimumab) finally began picking up market share. Speaking with AIS Health, a division of MMIT, industry experts reflect on the impact biosimilars had in 2024. (Editor’s note: These comments have been edited for length and clarity.)
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Dual IL-17A, IL-17 F Inhibitor Bimzelx Should Have Some Impact in PsA Space
UCB, Inc.’s Bimzelx (bimekizumab-bkzx) recently gained FDA approval for the treatment of psoriatic arthritis (PsA), bringing a new mechanism of action to the therapeutic class. Industry experts say it may be challenging to break into the crowded space, but if successful, it could impact coverage of and prescribing for the class.
On Sept. 20, the FDA approved three more indications for Bimzelx for the treatment of adults with active PsA, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. Two months later, on Nov. 20, the FDA gave the drug another approval, for the treatment of moderate-to-severe hidradenitis suppurativa.
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Study Reveals Home Infusion Pharmacists’ Vital Role With Specialty Drugs
In 2019, home infusion pharmacies served more than 315,000 specialty patients, with about 10% of total home infusion patients receiving specialty drugs. With these specialty products administered less often than nonspecialty drugs, there is limited data on how much time pharmacists spend on care planning and clinical involvement. But a recent study published in Infusion Journal — which is published by the National Home Infusion Association’s (NHIA) National Home Infusion Foundation (NHIF) — has revealed some details about that.
NHIF conducted a multicenter study of pharmacists from participating home infusion providers who reported the time they spent on clinical and administrative duties, tracking their time from when a patient was referred to the completion of two dispensing cycles.
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In Its Third and Final Biosimilar Deal of 2024, Coherus Divests Udenyca
Coherus BioSciences, Inc. is selling its third and last biosimilar per an agreement to divest its Udenyca (pegfilgrastim-cbqv) franchise to Intas Pharmaceuticals Ltd. for up to $558.4 million, Coherus revealed on Dec. 3. The granulocyte colony-stimulating factor is one of six biosimilars of Amgen Inc.’s Neulasta (pegfilgrastim). The FDA approved Udenyca on Nov. 2, 2018, making it the second of those agents to gain approval.
Included in the deal, which will give Coherus an upfront cash payment of $483.4 million, are the Udenyca prefilled syringe and autoinjector, as well as the Udenyca Onbody, an on-body injector that Coherus launched earlier this year. Udenyca is the only Neulasta biosimilar with that presentation, which competes with Neulasta Onpro, which has pulled market share from the original subcutaneous formulation.
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