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Forming Bioanalytical and Immunogenicity Strategies that Support Biosimilar Product Development

Forming Bioanalytical and Immunogenicity Strategies that Support Biosimilar Product Development

Bonita (Bonnie) Rup of Bonnie Rup Consulting, discusses PK and Immunogenicity in BiotherapeuticDevelopment and Use, What regulatory guidancessay about bioanalysis/immunogenicity analysis, What to consider in selecting the right population for your study, How to incorporate assay data into the overall study design, How to effectively interpret and present bioanalytical and immunogenicity data, and Types of Issues that Should be Discussed with Regulators.
Establising Structural Comparability with Effective Preclinical Characterization Methods

Establising Structural Comparability with Effective Preclinical Characterization Methods

Danny K. Chou, PharmaD, PhD President, Compassion BioSolution, LLC, presents on key issues in biosimilar drug product development, general strategy for developing biosimilars that are comparable with or superior to innovator drugs, how to improve market competitiveness by incorporating a high concentration formulation into pre-filled syringe or alternative delivery systems, the role of protein aggregate and subvisible particulate analysis in product stability monitoring and PFS development.
Biosimilars Regulations in the US Market: Where Do We Go From Here?

Biosimilars Regulations in the US Market: Where Do We Go From Here?

Thomas Sullivan, President, Rockpointe, takes a look at 2015-2016 at FDA and around the world, differences between EMA and FDA biosimilars regulations, FDA developments, CMS JCODES, state substitution laws, and the future of biosimilars.
Market Snapshot - Top 10 Biosimilars Manufacturers 2015

Market Snapshot - Top 10 Biosimilars Manufacturers 2015

With the approval of the first biosimilar product in the United States this year, cost containment pressures and a pending patent cliff, Pharma IQ takes a closer look at the current biosimilars market.

If you prefer to receive a copy via email contact us at enquiryIQPC@iqpc.com with the subject line 'Market Snapshot - Top 10 Biosimilars Manufacturers 2015 - Content Request'
The Future of Biosimilars - A Case of Untapped Potential?

The Future of Biosimilars - A Case of Untapped Potential?

The patents on a majority of the top-selling biologic drugs currently on the market will have expired by 2020, an amount which may be equivalent to $67 billion. Can we expect then a rush of biosimilar products to the market, drastically lowering spend on biological drugs? If current trends are anything to go by, the answer is maybe not.

If you prefer to receive a copy via email contact us at enquiryIQPC@iqpc.com with the subject line 'The Future of Biosimilars - A Case of Untapped Potential? - Article Request'
ASD - BIOSIMILARS - Regulatory Framework and Pipeline Analysis

ASD - BIOSIMILARS - Regulatory Framework and Pipeline Analysis

ASD Report about the regulatory framework and pipeline analysis in the Biosimilar industry.
Exclusive Interview: EMA & Health Canada

Exclusive Interview: EMA & Health Canada

Featuring EMA and Health Canada:
Meet our regulators, Andrea Laslop from the EMA and Agnes Klein from Health Canada, who will be giving keynote presentations and Q&A sessions at the upcoming Biosimilars Clinical Studies & Analytical Similarity Summit in Boston. Check out the interview below to hear their responses to some of the top challenges facing the biosimilars industry right now. Join them and other thought leaders at right here.the conference so you can ask your own questions in person.
Exclusive Interview: Global Head Biologics Safety Assessment at MedImmune Inc.

Exclusive Interview: Global Head Biologics Safety Assessment at MedImmune Inc.

Ahead of the Biosimilars Clinical Studies & Analytical Similarity Summit this March in Boston, we sat down with Dr. Rakesh Dixit, Vice President R&D, Global Head Biologics Safety Assessment at MedImmune Inc. to provide you with a sneak peek at what he will be discussing during his session at this years summit!
The Race to Develop Adalimumab Biosimilars

The Race to Develop Adalimumab Biosimilars

The impending loss of basic patent protection for adalimumab (commonly known as Humira), allied to the large revenues it generates, provides a clear incentive for other companies to develop adalimumab biosimilars in attempts to capture a share of over $10 billion revenues... Download the article to continue reading.

If you prefer to receive a copy via email contact us at enquiryIQPC@iqpc.com with the subject line 'The Race to Develop Adalimumab Biosimilars - Article Request'
Biosimilars Landscape and FDA Regulatory Expectations

Biosimilars Landscape and FDA Regulatory Expectations

The Congressional Budget Office (CBO) has estimated that the United States could save $25 billion from the use of biosimilars over 10 years, and according to analysis the worldwide market for biosimilars will grow to $3.7 billion by 2015
7 questions you might have about biosimilarity, answered

7 questions you might have about biosimilarity, answered

David Rosen, FDA practice group leader and co-chair of the Life Sciences Industry Team at Washington, D.C.-based Foley and Lardner, LLP, has more than 35 years of experience in various aspects of biopharmaceutical regulation, with a strong focus on generic drugs.

BioPharma Dive spoke to Rosen about the evolving role of biosimilars as an important part of the therapeutic landscape. Here, he weighs in not only on the new legislation, but also issues related to biosimilar approval, as well as naming conventions and how ultimately, the most important factors are safety, efficacy, and overall patient well-being.

If you prefer to receive a copy via email contact us at enquiryIQPC@iqpc.com with the subject line '7 questions you might have about biosimilarity, answered  - Interview Request'

Delivering on the Potential of Biosimilar Medicines

Delivering on the Potential of Biosimilar Medicines

This report from the QuintilesIMS Institute describes the potential role for biosimilars and their contribution to healthcare systems; the risks for stakeholders to realize that full potential value; and the requirements for competitive functioning markets in order to capture the full value. To learn more about the QuintilesIMS Institute, explore their website at www.QuintilesIMSInstitute.org or contact them at info@quintilesimsinstitute.org

To receive a copy of the report via email contact Gabbie.Dixon@iqpc.com

Pharmacovigilance on biologicals and biosimilars: a Danish perspective

Pharmacovigilance on biologicals and biosimilars: a Danish perspective

The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. This article is courtesy of Generics and Biosimilars Initiative (GaBi).
How the biosimilars market is changing

How the biosimilars market is changing

Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy and growing average age puts pressure on national healthcare systems. Courtesy of www.gabionline.net
Biosimilars: achieving long-term savings and competitive markets

Biosimilars: achieving long-term savings and competitive markets

As biosimilars begin to increase their share in the market, it is critical for payers to adopt strategic approaches to: (1) ensure a competitive and sustainable biosimilars market; (2) achieve value for money from their use. Here we propose a strategic approach we think could achieve bothgoals.