From The Stage

Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars, Immunogenicity

On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach to develop and validate ADA assays supporting biosimilar drug development programs. It has taken years of industry discussion and collaboration…

Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on bioanalytical strategies to support biosimilar programs. Learn more about the papers that collectively represent the culmination of years of discussions across industry and with regulators to create consensus recommendations that will hopefully help shape future regulatory guidelines.

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Todd Lester
Posted by Todd Lester / / Biosimilars, Immunogenicity

Immunogenicity assessments are a critical component to determining the comparability of an originator drug and a biosimilar. It is necessary to determine both neutralizing and non-neutralizing antibody incidence for an originator drug and a biosimilar, and understand the immunogenicity’s impact on PK results as well as its association with adverse events.

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

The global market for biosimilars is expected to grow at an exponential rate in coming years, from only $3 billion in 2016 to a forecasted $10 billion by 2021. So, it is not a surprise that biosimilar development has continued to be a hot topic in our industry in 2017, particularly related to regulation. To secure regulatory approval for a biosimilar, the manufacturer must demonstrate that the biological product is highly similar to its reference biological product, with no clinically meaningful differences in safety, purity, and potency. But, neither FDA…

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

Todd Lester
Posted by Todd Lester / / Biosimilars, Industry Update

The US Supreme Court reached a ruling last week that will allow biosimilar companies to launch new biosimilar drugs more quickly. The decision was unanimous that these companies will not need to provide the reference product sponsor with six months’ notice after US Food and Drug Administration (FDA) approval of their intention to launch a generic version of that biological drug. The case was brought to the Supreme Court over the biosimilar drug Zarxio, when the reference product sponsor and competing biosimilar developer disagreed over how language in the Biologics…

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

As per the Food and Drug Administration (FDA) guidance Quality Considerations in Demonstrating Biosimilarity to a Reference Product, a biosimilar is defined as “a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug…