News/Blogs
New Generic Drug, and Biosimilar Pipeline Report
By consistently monitoring the drug pipeline, you can ensure that you are providing the most clinically effective and cost-efficient options available. Here is what you can expect from our report:
- A list of newly approved brand-name drugs
- Key generic and biosimilar entries
- Administration routes, approval timelines, and cost projections
- Applicable therapeutic areas
We publish this pipeline report quarterly to assist your pharmacy benefit management planning and strategies. You can read about our clinical services and strategies or talk to a Sales Rep to learn more.
Download the Q4 2024 pipeline report PDF to save and share it with your clients and colleagues.
New Drug Pipeline
GENERIC NAME | BRAND NAME (Manufacturer if drug name unavailable) | ROUTE OF ADMINISTERED | STATUS | ESTIMATED COST | THERAPEUTIC AREA | SPECIALTY OR TRADITIONAL |
---|---|---|---|---|---|---|
Follitropin Delta | Rekovelle | Subcutaneous* | Approved Jun 2024 | TBD | Endocrine: Infertility | Specialty |
Garadacimab | (CSL Behring) | Subcutaneous | 2H2024 | $750,000 annually | Immunology | Specialty |
Insulin icodec | (Novo Nordisk) | Subcutaneous | 3Q2024 | $5,000 annually | Endocrine: Diabetes | Traditional |
Deuruxolitinib | (Concert/Sun) | Oral | Approved Jul 2024 | TBD | Dermatology: Alopecia Areata | Specialty |
Naloxone | Orexo | Nasal* | CRL Jul 2024 | TBD | Addiction/Substance Abuse | Traditional |
Nemolizumab | Mitchga | Subcutaneous | Approved Aug 2024 | $50,000 annually | Dermatology | Specialty |
Seladelpar | Livdelzi | Oral | Approved Aug 2024 | $110,000 annually | Gastrointestinal: Primary biliary cholangitis | Specialty |
Vorasidenib | Voranigo | Oral | Approved Aug 2024 | TBD | Cancer: Glioma | Specialty |
Midomafetamine (MDMA) | (MAPS PBC; Lykos Therapeutics) | Oral | CRL Aug 2024 | $5,000-$10,000 per course | Central Nervous System: Mood Disorders | Specialty |
Arimoclomol | Miplyffa | Oral | Sept 2024 | $500,000- $1,000,000 | Endocrine: Niemann-Pick disease Type C | Specialty |
Tradipitant | (Vanda Pharmaceuticals) | Oral | Sept 2024 | $10,000 per course | Gastroenterology: Nausea | Specialty |
Xanomeline; Trospium Chloride | KarXT | Oral | Sept 2024 | $20,000-$30,000 annually | Central Nervous System: Schizophrenia | Traditional |
Marstacimab | (Pfizer) | Subcutaneous | 4Q2024 | $500,000-$750,000 annually | Hematology | Specialty |
Lazertinib | (YuHan) | Oral | 4Q2024 | TBD | Cancer: Non- Small Cell Lung Cancer | Specialty |
Vicagrel | (Jiangsu Vcare Pharmatech) | Oral | 4Q2024 | $5,000-$10,000 annually | Cardiovascular: Acute Coronary Syndrome | Specialty |
Lebrikizumab | (Eli Lilly) | Subcutaneous | Oct 2024 | $50,000 | Dermatology: Atopic Dermatitis | Specialty |
Acoramidis | (BridgeBio/Eidos Therapeutics) | Oral | Nov 2024 | $200,000 – $300,000 annually | Endocrine: Metabolic | Specialty |
Govorestat | (Applied Therapeutics) | Oral | Nov 2024 | TBD | Endocrine: Metabolic | Specialty |
Inavolisib | (Roche/Genentech) | Oral | Nov 2024 | $300,000 annually | Oncology | Specialty |
Crinecerfont | (Neurocrine Biosciences) | Oral | Dec 2024 | $100,000-$300,00 annually | Endocrinology | Specialty |
Glepaglutide | (Zeland Pharma) | Subcutaneous | Dec 2024 | $540,000 annually | Gastrointestinal: Short Bowel Syndrome | Specialty |
Olezarsen | (Ionis Pharma) | Subcutaneous | Dec 2024 | $300,000-$500,00 annually | Endocrinology | Specialty |
Revumenib | (Syndax) | Oral | Dec 2024 | $300,000-$500,000 annually | Cancer: Leukemia | Specialty |
Sotagliflozin | (Lexicon Pharmaceuticals) | Oral | Dec 2024 | $5,000-$10,000 annually | Endocrinology: Diabetes | Traditional |
Elamipretaide | (Stealth BioTherapeutics) | Ophthalmic | Jan 2025 | $750,000-$1,000,000 annually | Central Nervous System | Specialty |
Suzetrigine | (Vertex) | Oral | Jan 2025 | $1,000 per course | Pain Management | Traditional |
Etripamil | Cardamyst | Nasal | Mar 2025 | $5,000 per course | Cardiovascular | Specialty |
Alnylam | Fitusiran | Subcutaneous | Mar 2024 | $500,000-$750,000 annually | Hematology | Specialty |
Generic and Biosimilar Pipeline
DRUG NAME | BRAND NAME | ROUTE OF ADMINISTRATION | STATUS | ESTIMATED 2023 US SALES (MILLIONS) | THERAPEUTIC AREA | BIOSIMILAR OR TRADITIONAL |
---|---|---|---|---|---|---|
Raltegravir | Isentress | Oral | 2024 | $355 | Anti-Infectives: HIV | Traditional |
Teduglutide | Gattex | Subcutaneous | 2024 | $500 | Gastrointestinal | Biosimilar |
Nilotinib | Tasigna | Oral | 1H2024 | $1,242 | Cancer: Leukemia | Biosimilar |
Dasatinib | Sprycel | Oral | Sept 2024 | $$2,528 | Cancer | Biosimilar |
Oxcarbazepine | Oxtellar XR | Oral | Sept 2024 | $230 | Central Nervous System: Epilepsy | Traditional |
Insulin Aspart (AMP-004) | Novolog | Intravenous/Subcutaneous | 4Q2024 | Endocrine: Diabetes | Traditional | |
Denosumab | Prolia | Subcutaneous | Nov 2024 | $3,753 | Cancer | Biosimilar |
Phentermine/Topirimate | Qsymia | Oral | Dec 2024 | $51 | Endocrine: Obesity | Traditional |
Omalizumab (CT-P39) | Xolair | Subcutaneous | 2025 | $3,390 | Respiratory: Asthma/COPD | Biosimilar |
Toclizumab (Tyenne) | Actemra | Intravenous* Subcutaneous* | Jan 2025 | $1,048 | Anti-Inflammatory | Biosimilar |
Sebetralstat | (KalVista Pharmaceuticals) | Subcutaneous) | 1Q2025 | $200,000-$300,000 annually | Immunology | Specialty |
Ustekinumab (Wezlana) | Stelara | Subcutaneous | Jan 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Ustekinumab (Selarsdi) | Stelara | Subcutaneous | Feb 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Ustekinumab (Pyzchiva) | Stelara | Subcutaneous | Feb 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Ustekinumab (Bmab 1200) | Stelara | Subcutaneous | Feb 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Ustekinumab (CT-P43) | Stelara | Subcutaneous | Mar 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Ustekinumab (FYB202) | Stelara | Subcutaneous | Apr 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Denosumab (Jubbonti) | Prolia | Subcutaneous | May 2025 | $3,760 | Musculoskeletal: Osteoporosis | Biosimilar |
Denoxumab (Wyost) | Xgeva | Subcutaneous | May 2025 | $2,061 | Cancer | Biosimilar |
Ustekinumab (DMB-3115) | Stelara | Subcutaneous | May 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Lecanemab | Leqembi | Subcutaneous | 2H2025 | $20,000-$50,000 annually | Central Nervous System | Specialty |
Ustekinumab (BAT2206) | Stelara | Subcutaneous | 2H2025 | $20,616 | Anti-Inflammatory | Biosimilar |
Key
Launched MM YYYY | Month and year drug was launched | Withdrawn | Drug has been withdrawn from FDA approval | ||||
Approved MM YYYY | Month and year drug was approved | CRL | Complete Response Letter – Incomplete FDA Application | ||||
Date | Updated release date |
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Past Quarterly Pipeline Reports
Click the links below to download past quarterly reports.
About Serve You Rx®
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what’s best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say “yes” to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.