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 ADMINISTRATION | STATUS | ESTIMATED COST | THERAPEUTIC AREA | SPECIALTY OR TRADITIONAL |
|---|---|---|---|---|---|---|
| Vicagrel | (Jiangsu Vcare Pharmatech) | Oral | Pending FDA Approval | $5,000-$10,000 annually | Cardiovascular | Specialty |
| Inavolisib | Itovebi | Oral | Approved Oct 2024 | $300,000 annually | Cancer | Specialty |
| Crinecerfont | Crenessity | Oral | Approved Dec 2024 | $300,000 annually | Endocrinology | Specialty |
| Olezarsen | Tryngolza | Subcutaneous | Approved Dec 2024 | $300,000-$500,00 annually | Cardiovascular | Specialty |
| Glepaglutide | (Zeland Pharma) | Subcutaneous | CRL Dec 2024 | $540,000 annually | Gastrointestinal: Short Bowel Syndrome | Specialty |
| Sotagliflozin | Zynquista | Oral | CRL Dec 2024 | $5,000-$10,000 annually | Endocrinology | Traditional |
| Sotorasib | Lumakras | Oral | Approved Jan 2025 | $250,000 annually | Cancer: Colon | Specialty |
| Suzetrigine | Journavx | Oral | Approved Jan 2025 | $1,000 per course | Pain Management | Traditional |
| Chenodiol | CTEXLI | Oral | Approved Feb 2025 | $500,000- $750,000 annually | Endocrine | Specialty |
| Mirdametinib | Gomekli | Oral | Approved Feb 2025 | $100,000- $200,000 annually | Cancer | Specialty |
| Vimseltinib | Romvimza | Oral | Approved Feb 2025 | $200,000- $300,000 annually | Cancer | Specialty |
| Etripamil | Cardamyst | Nasal | CRL Mar 2025 | $5,000 per course | Cardiovascular | Specialty |
| Deutivacaftor; Tezacaftor; Vanzacaftor | Alyftrek | Oral | Approved Dec 2025 | $350,000 annually | Central Nervous System | Specialty |
| Diazoxide Choline | Vykat XR | Oral | Mar 2025 | $200,000- $400,000 annually | Endocrinology | Specialty |
| Elamipretaide | (Stealth BioTherapeutics) | Ophthalmic | Apr 2025 | $750,000- $1,000,000 annually | Central Nervous System | Specialty |
| Delgocitinib | Corectim | Topical | 2H2025 | $5,000-$10,000 annually | Dermatology | Specialty |
| Sebetralstat | (KalVista Pharmaceuticals) | Oral | Jun 2025 | $200,000- $300,000 annually | Immunology | Specialty |
| Fitusiran | (Sanofi) | Subcutaneous | Pending | $500,000- $750,000 annually | Hematology | Specialty |
| Defactinib | Verastem | Oral | Jul 2025 | $200,000- $300,000 annually | Cancer: Ovarian | Specialty |
| Avutometinib | (Roche) | Oral | Jul 2025 | $200,000- $300,000 annually | Cancer: Ovarian | Specialty |
| Plozasiran | (Arrowhead) | Subcutaneous | Nov 2025 | $300,000- $500,000 annually | Cardiovascular | Specialty |
Generic and Biosimilar Pipeline
| DRUG NAME | BRAND NAME | ROUTE OF ADMINISTRATION | STATUS / EST LOE PROB | ESTIMATED 2024 US SALES (MILLIONS) | THERAPEUTIC AREA | BIOSIMILAR OR TRADITIONAL |
|---|---|---|---|---|---|---|
| Raltegravir | Isentress | Oral | 2025 (80%) | $355 | Anti-Infectives: HIV | Traditional |
| Teduglutide | Gattex | Subcutaneous | 2025 (50%) | $500 | Gastrointestinal | Biosimilar |
| Insulin Aspart (AMP- 004) | Novolog | Intravenous/ Subcuta neous | Approved Feb 2025 | $3,390 | Endocrine: Diabetes | Traditional |
| Denosumab | Prolia | Subcutaneous | Jun 2025 | $4,317 | Cancer | Biosimilar |
| Phentermine/ Topirimate | Qsymia | Oral | Jun 2025 (60%) | $51 | Endocrine: Obesity | Traditional |
| Ustekinumab (Steqeyma) | Stelara | Subcutaneous | Approved Dec 2024 | $22,196 | Anti-Inflammatory | Biosimilar |
| Ipratropium | Atrovent HFA | Inhaler | 2025 (50%) | 224 | Respiratory | Traditional |
| Rivaroxaban | Xarelto 2.5 mg | Oral | 1H2025 | <$10 | Cardiovascular | Traditional |
| Toclizumab (Tyenne) | Actemra | Intravenous* Subcutaneous* | Approved Jan 2025 | $1,048 | Anti-Inflammatory | Biosimilar |
| Ustekinumab (Wezlana) | Stelara | Subcutaneous | Approved Jan 2025 | $20,616 | Anti-Inflammatory | Biosimilar |
| Simlandi | Humira | Subcutaneous | Approved Feb 2025 | $89,994 | Anti-Inflammatory | Biosimilar |
| Ustekinumab (Pyzchiva) | Stelara | Subcutaneous | Approved Feb 2025 | $22,196 | Anti-Inflammatory | Biosimilar |
| Otulfi | Stelara | Subcutaneous | Launched Feb 2025 | $22,196 | Anti-Inflammatory | Biosimilar |
| Yesintek | Stelara | Subcutaneous Intravenous | Launched Feb 2025 | $22,196 | Anti-Inflammatory | Biosimilar |
| Ustekinumab (Selarsdi) | Stelara | Subcutaneous | Approved Feb 2025 | $2,196 | Anti-Inflammatory | Biosimilar |
| Concizumab | Alhemo | Subcutaneous | May 2025 | $500,000- $750,000 annually | Hematology | Biosimilar |
| Eslicarbazepine | Aptiom | Oral | May 2025 (70%) | $408M | Central Nervous System | Traditional |
| Perampanel | Fycompa | Oral | May 2025 (60%) | $225 | Central Nervous System | Traditional |
| Ticagrelor | Brilinta | Oral | May 2025 (80%) | $1,400 | Cardiovascular | Traditional |
| Ustekinumab (BAT2206) | Stelara | Subcutaneous | May 2025 | $22,196 | Anti-Inflammatory | Biosimilar |
| Eltrombopag | Promacta | Oral | 2H2025 (70%) | $2,228 | Hematology | Biosimilar |
| Nilotinib | Tasigna | Oral | 2H2025 (60%) | $1,209 | Cancer | Biosimilar |
| Denosumab (Wyost) | Xgeva | Subcutaneous | Jun 2025 | $2,136 | Cancer | Biosimilar |
| Glycerol Phenylbutyrate | Ravicti | Oral | Jul 2025 (90%) | $528 | Endocrinology | Biosimilar |
| Sacubitril; Valsartan | Entresto | Oral | Jul 2025 (60%) | $6,558 | Cardiovascular | Traditional |
| Linagliptin | Tradjenta | Subcutaneous | Nov 2025 (70%) | $1,444 | Endocrinology | Traditional |
| Macitentan | Opsumit | Oral | 4Q2025 (60%) | TBD | Cardiovascular | Biosimilar |
| Tolvaptan | Jynarque | Oral | 2025 (60%) | $1,851 | Endocrinology | Biosimilar |
| Bosutinib | Bosulif | Oral | 2025 (70%) | $654 | Cancer | 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.
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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.
