Although the number of specialty drug approvals is increasing, there is still much work to be done in the specialty area, especially in rare diseases and non-alcoholic steatohepatitis (NASH). During the keynote session at the Nexus 2023 Academy of Managed Care Pharmacy conference, Aimee Tharaldson, PharmD, clinical program principal of Emerging Therapies at Evernorth, discussed market trends on specialized drugs and drugs currently being deployed.
Special trends are a lot higher than traditional trends at 8.7% versus 3.4%, but it’s important to know that it’s less than 2%. [individuals] Tharaldson said during the session: use specialized drugs, but of course, they are very expensive, on average 3,500 USD a month.
Tharaldson identified key market trends for specialty drugs that fall into three categories: biosimilars, oncology drugs, and orphan drugs. Leading groups for specialty therapies include inflammatory conditions, cancer, HIV and multiple sclerosis (MS).
According to Tharaldson, there are currently 43 approved biosimilars for 13 biologic drugs and 37 for 10 biologic drugs on the market. There are also eight biosimilars to adalimumab (Humira; AbbVie) currently on the market, and etanercept (Enbrel; Amgen) will have exclusivity until 2029. Etanercept will be a notable drug in addition to tocilizumab ( Actemra; Genentech), golimumab (Simponil). ; Janssen Immunology) and ustekinumab (Stelara; Janssen Immunology), according to Tharaldson.
Orphan drugs are another particularly important market trend, according to Tharaldson. She added that when looking at new specialty drugs awaiting approval, two-thirds are for orphans.
Last year, the FDA approved 32 new specialty drugs and 9 traditional drugs, and so far this year, as of yesterday, 35 new specialty drugs have been approved, as of now. of this year, and 16 more are expected before the end of the year. We could have 51 special approvals this year, which would beat the previous record of 11, Tharaldson said during the session.
Tharaldson also discussed 10 pipeline therapy groups of particular interest: inflammatory conditions, MS, HIV, NASH, Alzheimer’s disease (AD), paroxysmal nocturnal hemoglobinuria (PNH), Duchenne muscular dystrophy ( DMD), hemophilia, and gene and cell therapies.
Following today’s approval of bimekizumab (UCB), other inflammatory drugs in the pipeline include infliximab (Celltrion), mirikizumab (Eli Lilly), and secukinumab (Cosentyx; Novartis) in the fourth quarter of 2023. Risankizumab-rzaa (Skyrizil AbbVie), vedolizumab (Entyvio; Takeda) and lebrikizumab (Eli Lilly) are expected to launch in 2024.
For MS, there are 6 drugs in the pipeline, half expected in 2024 and half in 2025, including glatiramer acetate, GA depot (Viatris, Mapi Pharma), ocrelizumab (Ocrevus SC; Genentech) , evobrutinib (EMD Serono), fenebrutinib (Genentech), orelabrutinib (Biogen), and tolebrutinib (Sanofi).
According to Tharaldson, there aren’t many drugs in production, just two in production: rilpivirine (Edurant; Jansen), scheduled to launch in May 2024, and islatravir (Merck), expected in early 2025.
Currently, NASH has limited treatment options and many comorbidities, including high cholesterol, type 2 diabetes, insulin resistance, and obesity. However, the portfolio currently includes 11 drugs, likely to be approved between 2024 and 2027. These drugs include resmetirom (Madrigal Pharmaceuticals), aramchol (Galmed Pharmacuticals), belapectin (Galectin Therapy), denifanstat (Sagimet Biosciences), efinopegdutide (Merck), efruxifermin (Akero), semaglutide (Novo Nordisk), TERN-501 (Terns Pharmaceuticals), VK2809 (Viking Therapeutics), cilofexor (Gilead) and Firsocostat (Gilead).
NASH has the potential to become a huge market but there are still many unknowns. We don’t yet have the data to know what the long-term benefits are by actually reducing the risk of patients progressing to cirrhosis from liver transplantation,” Tharaldson said.
AD has four potential treatment drugs in the pipeline with donanemab (Eli Lily) expected in December 2023, E2814 (Eisai) in 2026, and posdinemab (Janssen) and semorinemab (Genentech) expected. in 2027. PNH currently has 3 drugs in the pipeline: iptacopan (Novartis) expected in December 2023 and crovalimab (Genentech) and danicopan (AstraZeneca) expected in 2024 .
DMD also has three drugs in the pipeline with two expected by the end of 2023: vamorolone (Santhera, ReveraGen) and givinostate (Italfarmaco SpA). Fordadistrogene movaparvovec (Pfizer) is expected to launch in 2024.
In the hemophilia pipeline, there are fidanacogene elaparvovec (Pfizer), concizumab (Novo Nordisk), diroctocogene samoparvovec (Genentech), marstacimab (Pfizer), and Mim8 (Novo Nordisk). Giroctocogene fitelparvovec (Sangamo, Pfizer) is expected to launch in 2025. Fidanacogene elaparvovec, diroctocogene samoparvovec and giroctocogene fitelparvovec are gene therapies.
Other gene and cell therapies expected to be deployed in 2023 are exagagglogene autotemcel (Vertex, CRISPR) and lovotibeglogene autotemcel (bluebird bio), which are seeking indications for sickle cell disease. In 2024, gene and cell therapies include lifileucel (Iovance Biotherapeutics) for advanced melanoma and atidarsagene autotemcel (Orchard Therapeutic) for heterochromatic leukodystrophy.
Tharaldson concluded the presentation with four selected specific drugs currently in development. Cinaxadamtase alfa (Takeda) for congenital thrombotic thrombocytopenic purpura, expected November 2023; eplontersen (Ionis, AstraZeneca) for the treatment of transthyretin-mediated amyloid polyneuropathy expected in December 2023; and sotatercept (Merck) for the treatment of pulmonary arterial hypertension scheduled for March 26, 2024. Zilucoplan (UCB) was originally scheduled for approval in December 2023, but was approved early on October 17, 2023.
Authority to solve
Tharaldson A. Specialty pharmaceuticals in development. AMCP Nexus 2023. Orlando, Florida. October 18, 2023. Accessed October 18, 2023.
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