Highly Specialized Biologics Experience | Amgen Biosimilars

Highly Specialized Biologics Knowledge

Amgen brings extensive experience in innovator biologics to its biosimilars

We are end-to-end biologics experts

Biologics development is a highly skilled, multistep process1—and Amgen has extensive experience in all phases, from development to manufacturing, aiming to deliver a reliable supply.
Biosimilars development is equally complex,1 and our innovator biologics expertise, gathered over four decades, means that we’re prepared for the task. We use the same processes, scientific standards, and quality systems for our biosimilars as we do for our innovator biologics.

Fundamental principles of biosimilar manufacturing

Fundamental principles of biosimilar manufacturing1-3

Engineering a biosimilar

On the basis of a reference biologic’s critical quality attributes (CQAs), a biosimilar is engineered to be highly similar in terms of host cell proteins, product attributes, variants, process impurities, and stability profile.

Characterization and comparative studies

High similarity in analytical and pharmacokinetic/pharmacodynamic (PK/PD) data between the reference biologic and the biosimilar indicates a lower risk of clinical differences.

Quality standards in manufacturing

Rigorous quality standards throughout the manufacturing process and extensive risk assessments to promote quality.

References: 1. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 2. Aspirin Prescribing Information, Bayer. 3. Humalog® (insulin lispro injection) Prescribing Information [revised 2017], Eli Lilly. 4. Humatrope® [somatropin (rDNA ORIGIN)] Prescribing Information [revised 2016], Eli Lilly. 5. Taltz® (ixekizumab) Prescribing Information [revised 2017], Eli Lilly. 6. Nickish K, Bode-Greuel KM. NPV modelling for the selection of value-creating biosimilar development candidates. J Commer Biotechnol. 2013;19:24-32.