State-of-the-Art Analytics in Biosimilar mAb Development: From Analytical Similarity to Clinical Confidence

Atik A. E.

6th Life Sciences Congress, Kayseri, Türkiye, 13 - 15 Şubat 2026, (Yayınlanmadı)

  • Yayın Türü: Bildiri / Yayınlanmadı
  • Basıldığı Şehir: Kayseri
  • Basıldığı Ülke: Türkiye
  • Acıbadem Mehmet Ali Aydınlar Üniversitesi Adresli: Evet

Özet

Biosimilar drugs are biological medicinal products that are highly similar to an already approved reference product, with no clinically meaningful differences in terms of quality, safety, and efficacy. Today, the development of biosimilar monoclonal antibodies (mAbs) has entered a new era where advanced analytical characterization has emerged a key role in building regulatory confidence. State-of-the-art analytical technologies enable highly sensitive and comprehensive assessment of biosimilarity across critical quality attributes (CQAs). Recent draft guidance from the U.S. Food and Drug Administration (FDA) highlights that robust analytical similarity, when supported by clinical pharmacology studies, may be sufficient to demonstrate biosimilarity without the need for a Phase III clinical efficacy study (CES).

This presentation will highlight how state-of-the-art analytical platforms—including high-resolution mass spectrometry, post-translation modification analysis, glycosylation and charge variant profiling, size heterogeneity evaluation, higher-order structure characterization, and functional and binding assays—collectively establish a detailed similarity fingerprint between biosimilar and reference mAbs. These orthogonal analytical approaches are essential for defining CQAs and enabling comprehensive comparability assessments, including evaluations under forced degradation conditions.

In summary, the talk emphasizes how analytics-driven development strategies are reshaping biosimilar development steps and regulatory expectations. This approach supports a more efficient and patient-centered approval process by reducing the costs of clinical studies and accelerating patient access to high-quality biosimilar medicines.