From The
Stage

Expert perspectives focused on the latest bioanalytical topic & trends
|

Difference Between Biobetters and Biosimilars

According to research compiled by Reports and Data, in 2018 the global biologics market was valued at over $250 million, but is projected to reach an estimated $625 million by the end of 2026 with an 11.9% compound annual growth rate (CAGR). Biologics are medications made up of proteins, sugars, or DNA, and oftentimes are a complex combination of these materials and by-products. Biologics can also be composed of living

Read More »
BioAgilytix AAPS white paper webinar blog

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

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

Read More »
Picture of a Biosimilar white paper

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

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.

Read More »

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

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.

Read More »
Immunogenicity of Biosimilars

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars

An increasing number of patents for originator biologic products are due to expire, and therefore opportunity within the industry to develop additional biosimilars is growing. In response, more pieces of relevant guidance are being developed, and the increased knowledge being gained by the industry as a whole will continue to inform best practices in evolving biosimilar development processes, including those for immunogenicity testing. According to most recent FDA and EMA

Read More »

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

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

Read More »

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

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

Read More »

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

According to research from the Biosimilars Council, $81 billion worth of brand name biologics will lose their patents by 2020. As a result, we are seeing a significant increase in the development of lower cost biosimilar alternatives, as well as more applications for FDA approval of biosimilars for expiring biologic drugs. In fact, this market is expected to grow more than 25-fold over the next five years. But because the

Read More »

Speak To A Scientist





    I consent to receive communications (which may include, phone, email, social, and re-targeting ads) from BioAgilytix. I understand I may proactively manage my preferences or opt-out of communications with BioAgilytix at any time using the unsubscribe link provided in all of BioAgilytix’s email communications and can learn more by reading the privacy policy.