What were the biologic-based drugs approved by FDA’s Center for Drug Evaluation and Research in 2024? Which companies and products crossed the regulatory finish line and how do they fit in the market?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Biologics approvals by FDA’s CDER
In 2024, the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration approved 16 biological therapeutics, which represented 32% of new drug approvals (new molecular entities and biological therapeutics) by FDA’s CDER. This was on par with 2023, when FDA’s CDER approved 17 new biological therapeutics, which represented 31% of new drug approvals by FDA’s CDER in 2023. FDA’s CDER reviews and approves new molecular entities and new biological therapeutics. Other biologic-based products, including blood products, vaccines, allergenics, tissues, and cellular and gene therapies, are reviewed and approved by a separate center within FDA, the Center for Biologics Evaluation and Research (CBER). 

CDER biologics approval: Big Pharma
Biologics approved by FDA’s CDER from the large pharma companies included: Novo Nordisk’s Alhemo (concizumab-mtci) for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A or B with inhibitors; Eli Lilly and Company’s Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe eczema (atopic dermatitis); Lilly’s Kisunla (donanemab-azbt) for treating early symptomatic Alzheimer’s disease; Pfizer’s Hympavzi (marstacimab-hncq) for treating hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors; Amgen’s Imdelltra (tarlatamab-dlle) for treating extensive stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy; Roche’s Piasky (crovalimab-akkz) for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disease that causes red blood cells to break down; Astellas’s Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma; and Merck & Co.’s Winrevair (sotatercept-csrk) for treating pulmonary arterial hypertension (PAH), one form of a broader condition known as pulmonary hypertension, which refers to high blood pressure in the lungs.

CDER biologics approval: Mid to small companies
Biologics approved in 2024 by FDA’s CDER from small to mid-sized companies included: Altor Bioscience’s Anktiva (nogapendekin alfa inbakicept-pmln) for treating non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors that is unresponsive to prior therapy with Bacillus Calmette-Guérin; Merus’ Bizengri (zenocutuzumab-zbco) for treating unresectable or metastatic non-small cell lung cancer; Hugel’s Letybo (etibotulinumtoxinA-wlbg) for treating moderate-to-severe glabellar (frown) lines; Galderman Labs’ Nemluvio (nemolizumab-ilto) for treating prurigo nodularis, a chronic skin disorder characterized by multiple pruritic papules, plaques, and nodules.; Incyte’s Niktimvo (axatilimab-csfr) for treating chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy; Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) for treating metastatic cutaneous squamous cell carcinoma, a  type of skin cancer that develops in the squamous cells of the epidermis; BeiGene’s Tevimbra (tislelizumab-jsgr) for treating esophageal squamous cell carcinoma; and Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) for treating previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, a rare and aggressive type of cancer that affects the organs of the biliary system, which includes the gallbladder and bile ducts.

Biologics’ market strength: top-selling biologics
Biologic-based products represent an important part of the commercial portfolios of the top bio/pharmaceutical companies and overall in the industry. Using various market analyses of the top 10 selling products in 2023, seven were biologics. These included: Merck & Co.’s Keytruda (pembrolizumab), an immunotherapy for treating multiple cancers; AbbVie’s Humira (adalimumab) for treating various inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis; Pfizer’s/BioNTech’s Comirnaty (COVID-19 vaccine mRNA), a vaccine for COVID-19; Bayer’s and Regeneron Pharmaceuticals’ Eylea (aflibercept) for treating age-related macular degeneration, macular edema, and diabetic retinopathy; Sanofi’s and Regeneron Pharmaceuticals’ Dupixent (dupilumab) for treating moderate-to-severe eczema (atopic dermatitis), moderate-to-severe eosinophilic or oral steroid-dependent asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and chronic obstructive pulmonary disease; Johnson & Johnson’s Stelara (ustekinumab) for treating moderate-to-severe inflammatory conditions, including  plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis; and Bristol-Myers Squibb’s and Ono Pharmaceutical’s Opdivo (nivolumab), an immunotherapy for treating multiple cancers.

Depending on the market analysis used, another seven biologics made the top 20-selling drugs in 2023. These included: Johnson & Johnson’s Darzalex/Darzalex Faspro (daratumumab) for treating multiple myeloma; Merck & Co.’s Gardasil/Gardasil 9 (human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by the human papillomavirus; AbbVie’s Skyrizi (risankizumab‐rzaa) for treating moderate-to-severe plaque psoriasis, active psoriatic arthritis., moderate-to severe Crohn’s disease, and moderate-to-severe ulcerative colitis; Eli Lilly and Company’s Trulicity (dulaglutide) for treating Type 2 diabetes; Roche’s Ocrevus (ocrelizumab) for treating multiple sclerosis; Moderna’s Spikevax (COVID-19 vaccine mRNA), a vaccine for preventing COVID-19; and Pfizer’s Prevnar (Pneumococcal vaccine), a vaccine against multiple strains of the bacteria that cause pneumococcal pneumonia.