2025 FDA approvals: Formulation Outlook
In 2025, the US FDA has approved 46 novel drugs that year. Amongst those, 12 biologics—accounting roughly 25% of total approvals—include antibody-drug conjugates (ADCs), fusion proteins, and both mono- and bispecific monoclonal antibodies. While oncology remained the primary focus for the approved biologics, recent approvals also span a diverse range of therapeutic areas, including pulmonary, cardiovascular, renal, immunology, and neurology.
2025 FDA approvals: Formulation Outlook
In 2025, the US FDA has approved 46 novel drugs that year. Amongst those, 12 biologics—accounting roughly 25% of total approvals—include antibody-drug conjugates (ADCs), fusion proteins, and both mono- and bispecific monoclonal antibodies. While oncology remained the primary focus for the approved biologics, recent approvals also span a diverse range of therapeutic areas, including pulmonary, cardiovascular, renal, immunology, and neurology. (see graphic 1 underneath).
Key Takeaways from Antibody Therapeutic Formulations
- Patient-Friendly Administration: About 42% of 2025 approved mAbs are delivered via the subcutaneous (SC) route, highlighting the need for improved convenience for patients.
- High Protein Concentration:6 out of 12 mAbs have concentrations greater than 150 mg/mL, indicating a trend toward high-concentration formulations.
- Dosage Forms: All approved biologics (except ADCs) are in liquid formulations. This highlights the potential that liquid formulations bear and the importance to avoid lyophilization, whenever possible.
- Buffer Systems:Histidine is the dominant buffer, used in 90% of formulations, while acetate and citrate buffers are used in one product each.
- Surfactants & Stabilizers:
- Polysorbate 80 is present in all formulations as a surfactant. PS20 or Poloxamer were not used in those approved products.
- Sucrose is the most common stabilizer (used in over 50% of products), often combined with methionine and/or arginine.
- Sorbitol is the next preferred stabilizer, also paired with arginine.
- Unique Formulation:Garadacimab stands out by using proline with arginine HCl instead of any sugar or polyol.
- Amino Acids: More than 50% of formulations include arginine and/or methionine, particularly in high-concentration products.
- Permeation Enhancers: 2025 marked the approval of the first subcutaneous co-administered product using an alternative recombinant human hyaluronidase variant—berahyaluronidase alfa. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is the first product to incorporate berahyaluronidase alfa and is available in two configurations: 2.4 mL and 4.8 mL.
Key Takeaways on Administration and Delivery:
The growing number of approved products (e.g., HERCEPTIN HYLECTA®, RITUXAN HYCELA®) strenghtens the transition from intravenous (IV) infusion to subcutaneous (SC) administration as a key lifecycle management strategy. Advances in SC delivery technologies have enabled this shift—through co- or subsequent administration of hyaluronidases or by leveraging innovative SC delivery devices such as on-body injectors (OBIs).
About are delivered via the subcutaneous (SC) route, highlighting convenience for self-administration. 7 out of these 9 subcutaneously administered products are available in devices, highlighting the right-first-time approach towards patient friendly administration.
Injection devices represent the pinnacle of convenience for patients, enhancing comfort, adherence, and overall satisfaction. These devices, typically arriving as ready-to-use products, streamline handling, eliminating the need for additional manipulation and reducing errors.
Expertise Matters: With the diversification of modalities & antibody type (bispecific & IgG4) and surge in high concentration biologics, the development of robust formulations, the adequate choice and integration with appropriate primary packaging and device and robust manufacturing processes demands strong technical know-how. At ten23, we pride ourselves on continuously expanding our expertise in high concentration formulation development, viscosity optimization, device selection and integration covering delivery ranges from 1 mL (or less) to 10 mL (or more), sterile manufacture of vials, syringes and cartridges and related testing.
People, Patients, and Planet First: Our developmental strategies are always aligned with industry standards, putting our patients, people, and planet at the forefront of our decisions and actions. Contact us for more details on how we can support your development strategy.
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