Our biosimilars are produced in established facilities with over 20 years of experience in manufacturing biologics
Around 40 different analytical methods are used to assess approximately 100 different drug characteristics for biosimilarity between the biosimilar candidate and the reference product.
After the manufacturing process has been developed, clinical and nonclinical studies that compare the biosimilar with the reference product can take place:
Based on the totality of evidence, our biosimilar approvals are approved by meeting the FDA’s requirements for biosimilarity
