Business of Biotech Shorts

  1. In Biosimilar Analytical Development, Is A CQA Ever Not Critical? 4/20/2026

    The word "critical" implies a binary signal. The attribute is either existentially important or it's not.

  2. Standards' Role In Biosimilarity Assessment 4/20/2026

    Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

  3. The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval 4/20/2026

    The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(k) applications for biosimilars.

  4. The Necessity Of Potency Assay Matrices For Complex Proteins 4/20/2026

    For complex proteins, the FDA requires a matrix of orthogonal potency assays. Sponsors must assess all functional activities of a product, especially when the mechanism of action is known.

  5. In The U.S., Pharmacy-Level Biosimilar Substitution Remains A High Bar 4/20/2026

    Recent changes in the FDA's biosimilarity assessment guidance do not address the other side of the biosimilar coin, interchangeability. Unique to the U.S., pharmacy-level substitution is allowed only when companies clear an additional regulatory hurdle of receiving an interchangeability designation.

  6. How To Avoid A Biosimilar Comparative Efficacy Study, If Possible 4/20/2026

    Few companies, if any, would ever eagerly volunteer to perform a comparative efficacy study (CES) for their biosimilar candidate. The FDA has been clear all along that compelling a CES remains a tool in its toolbox if the agency believes it's necessary. So what might trigger one, and how can companies avoid it?

  7. Building A Comprehensive Control Strategy For Biosimilar Analytics 4/20/2026

    Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

  8. Comparing Biosimilars To Drifting Reference Product Data 4/20/2026

    First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.

  9. Criticism Of FDA's Limited Proof-Of-Principle Ignores The Full Breadth Of Biosimilar CQA Understanding 4/20/2026

    Critics say adalimumab and trastuzumab, two of the most well-characterized antibodies on the market and each with their several approved biosimilars, provide a limited basis for proof of principle. During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, panelists agreed that the full body of evidence includes approved biosimilars with diverse mechanisms of action and complex glycostructures.

  10. Levers For Streamlining And Optimizing The Biosimilar Process 4/20/2026

    New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.