2023 EMA Recommendations: Formulation Outlook 🔬

Authors: Sumantha Dayananda and VENKATA APPA REDDY GOLI , Subject Matter Experts at ten23 health.

In 2023, the EMA provided a remarkable count of recommendations (77 positive opinions) for authorization, with 39 groundbreaking new substances making their European Union debut. These medicines are not only meeting public health needs but also showcasing innovative characteristics. Link to article.

🌟 Noteworthy Trend:

• Protein therapeutics continue to lead with a significant share of approvals (11 products) – as per graphic below:

When analyzing the formulation composition of antibody therapeutics, a number of key insights emerge:

1.Subcutaneous products on the rise:

🟣Over 65% of approved products opt for the subcutaneous (SC) route, highlighting its popularity.

🟣Interestingly, the SC percentage surpasses FDA approvals (see previous post), though the proportion of high concentration formulations stands at 35%.

2.Bispecific Antibodies:

🟣Four out of nine antibody therapeutics are bispecific, higher than the FDA's 33%.

🟣The superior clinical effects of bispecific antibodies lead to lower doses and fewer high concentration products.

3.All approved products come in liquid forms.

4.Histidine buffer is the favored choice among buffers used.

5.Sucrose plays a critical role as a stabilizer, often in combination with methionine and EDTA, likely for potential mitigation of oxidation of polysorbate and/or API .

6.Among the surfactants, PS 80 slightly dominates (56%) over PS 20, a percentage lower than FDA-approved products.

These are exciting times in biologics development. With the surge in high concentration biologics, the development of robust processes and formulations demands strong scientific know-how. ten23 health can help you setting the right approach from the very start.

🟣At ten23 health, we pride ourselves on continuously expanding our expertise in high concentration formulation development, viscosity optimization, device selection and integration. Find out more about our services here: Pharmaceutical Product Design | ten23 health

🟢Discover how our developmental strategies align with our industry standards, putting #Patients, #People, and #Planet at the forefront: Patients, People, Planet | ten23 health