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 Q1 2025 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 |
|---|---|---|---|---|---|---|
| Lazertinib | Lazcluze | Oral | Approved Aug 2024 | $200,000-$300,000 annually | Cancer: Non- Small Cell Lung Cancer | Specialty |
| Arimoclomol | Miplyffa | Oral | Approved Sept 2024 | $500,000-$1,000,000 | Endocrine: Niemann-Pick disease Type C | Specialty |
| Lebrikizumab | Ebglyss | Subcutaneous | Approved Sept 2024 | $50,000 | Dermatology: Atopic Dermatitis | Specialty |
| Tradipitant | (Vanda Pharmaceuticals) | Oral | CRL Sept 2024 | $10,000 per course | Gastroenterology: Nausea | Specialty |
| Xanomeline; Trospium Chloride | Cobenfy | Oral | Approved Sept 2024 | $20,000-$30,000 annually | Central Nervous System: Schizophrenia | Traditional |
| Garadacimab | (CSL Behring) | Subcutaneous | CRL Oct 2024 | $750,000 annually | Immunology | Specialty |
| Marstacimab | Hympavzi | Subcutaneous | Approved Oct 2024 | $500,000-$750,000 annually | Hematology | Specialty |
| Vicagrel | (Jiangsu Vcare Pharmatech) | Oral | 4Q2024 | $5,000-$10,000 annually | Cardiovascular: Acute Coronary Syndrome | Specialty |
| Acoramidis | Attruby | Oral | Approved Nov 2024 | $200,000 -$300,000 annually | Endocrine: Metabolic | Specialty |
| Inavolisib | Itovebi | Oral | Nov 2024 | $300,000 annually | Cancer | Specialty |
| Revumenib | Revuforj | Oral | Approved Nov 2024 | $300,000-$500,000 annually | Cancer: Leukemia | Specialty |
| Govorestat | (Applied Therapeutics) | Oral | CRL | $300,000-$500,000 annually | Endocrine: Metabolic | Specialty |
| Crinecerfont | (Neurocrine Biosciences) | Oral | Dec 2024 | $300,000 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 | Cardiovascular | Specialty |
| Sotagliflozin | (Lexicon Pharmaceuticals) | Oral | Dec 2024 | $5,000-$10,000 annually | Endocrinology: Diabetes | Traditional |
| Deutivacaftor; Tezacaftor; Vanzacaftor | (Vertex Pharmaceuticals) | Oral | Jan 2025 | $350,000 annually | Central Nervous System | Specialty |
| Elamipretaide | (Stealth BioTherapeutics) | Ophthalmic | Jan 2025 | $750,000-$1,000,000 annually | Central Nervous System | Specialty |
| Sotorasib | Lumakras | Oral | Jan 2025 | $250,000 annually | Cancer: Colon | Specialty |
| Suzetrigine | (Vertex) | Oral | Jan 2025 | $1,000 per course | Pain Management | Traditional |
| Mirdametinib | (Pfizer) | Oral | Feb 2025 | $100,000-$200,000 annually | Cancer | Specialty |
| Vimseltinib | (Ono Pharmaceuticals) | Oral | Feb 2025 | $200,000-$300,000 annually | Cancer | Specialty |
| Diazoxide Choline | Soleno Therapeutics | Oral | Mar 2025 | $200,000-$400,000 annually | Endocrine | Specialty |
| Defactinib | Pfizer | Oral | 2Q2025 | $200,000-$300,000 annually | Cancer: Ovarian | Specialty |
| Etripamil | Cardamyst | Nasal | Mar 2025 | $5,000 per course | Cardiovascular | Specialty |
| Fitusiran | Sanofi | Subcutaneous | Mar 2025 | $500,000-$750,000 annually | Hematology | Specialty |
| Avutometinib | Roche | Oral | 2Q2025 | $200,000-$300,000 annually | Cancer: Ovarian | Specialty |
| Sebetralstat | KalVista Pharmaceuticals | Oral | Jun 2025 | $200,000-$300,000 annually | Immunology | Specialty |
| Chenodal | Mirum Pharmaceuticals | Oral | 2H2025 | $500,000-$750,000 annually | Endocrine | Specialty |
| Delgocitinib | LEO Pharma | Topical | 2H2025 | $5,000-$10,000 annually | Dermatology | Specialty |
| Plozasiran | Arrowhead | Subcutaneous | 3Q2025 | $300,000-$500,000 annually | Cardiovascular | 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 | 2025 | $355 | Anti-Infectives: HIV | Traditional |
| Phentermine/ Topirimate | Qsymia | Oral | Dec 2024 | $51 | Endocrine: Obesity | Traditional |
| Teduglutide | Gattex | Subcutaneous | 2025 | $500 | Gastrointestinal | Biosimilar |
| Denosumab | Prolia | Subcutaneous | 2025 | $3,753 | Cancer | Biosimilar |
| Insulin Aspart (AMP-004) | Novolog | Intravenous/Subcutaneous | 1H2025 | $3,390 | Endocrine: Diabetes | Traditional |
| Denosumab | Prolia | Subcutaneous | $3,753 | Cancer | Biosimilar | |
| Toclizumab (Tyenne) | Actemra | Intravenous* Subcutaneous* | Jan 2025 | $1,048 | Anti-Inflammatory | Biosimilar |
| Ustekinumab (Wezlana) | Stelara | Subcutaneous | Jan 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Simlandi | Humira | Subcutaneous | Feb 2025 | $89,994 | 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 |
| Denosumab (Jubbonti) | Prolia | Subcutaneous | Mar 2025 | $3,760 | Musculoskeletal: Osteoporosis | Biosimilar |
| Denoxumab (Wyost) | Xgeva | Subcutaneous | Mar 2025 | $2,061 | Cancer | Biosimilar |
| Ustekinumab (CT-P43) | Stelara | Subcutaneous | Mar 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Ustekinumab (BAT2206) | Stelara | Subcutaneous | 2Q2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Cyltezo HC | Humira | Subcutaneous | Apr 2025 | $89,994 | Anti-Inflammatory | Biosimilar |
| Hercessi | Herceptin | Intravenous | Apr 2025 | $559 | Cancer | Biosimilar |
| Selarsdi | Stelara | Subcutaneous | Apr 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Concizumab | Novo Nordisk | Subcutaneous | 2H2025 | $500,000-$750,000 annually | Hematology | Biosimilar |
| Lecanemab | Leqembi | Subcutaneous | 2H2025 | $20,000-$50,000 annually | Central Nervous System | Specialty |
| Nilotinib | Tasigna | Oral | 2H2025 | $1,242 | Cancer: Leukemia | Biosimilar |
| Ahzantive | Neupogen | Intravenous Subcutaneous | Jun 2025 | $139 | Hematologic | Biosimilar |
| Pyzchiva | Stelara | Intravenous Subcutaneous | Jun 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Otulfi | Stelara | Subcutaneous | Sep 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Imuldosa | Stelara | Subcutaneous | Oct 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Selarsdi | Stelara | Intravenous | Oct 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Yesintek | Stelara | Subcutaneous Intravenous | Nov 2025 | $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 | ||||||
Nothing herein is or shall be construed as a promise or representation regarding past or future events, and Serve You Rx expressly disclaims any and all liability relating to the use or reliance on the information contained in this publication. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Serve You Rx.
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.
