The Future of Biosimilars: Addressing Regulatory Challenges

The Future of Biosimilars: Addressing Regulatory Challenges

19-06-2014 - 19-06-2014

This 90-minute online course will give you the tools to bring your products to market in a swift and compliant manner. Examples of successful and unsuccessful submissions will be discussed, as well as major differences between US and EMA regulations and World Health Organization (WHO) guidelines.

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 serves as FDA’s current framework for biosimilars, but there is a great of deal confusion surrounding this legislation and regulatory pathways for approval.  Many companies that have plans to enter the biosimilars market are awaiting direction on how to proceed. FDA plans to release new documents in 2014 that will further define compliance and signal the development of new therapies as patents for innovator biopharmaceutical products approach expiration.

What can we learn from what has worked to date and what hasn’t?

The European Medicine Agency (EMA) has approved 12 biosimilar products to date including life-saving therapies that treat psoriatic arthritis, Crohn’s disease, psoriasis, rheumatoid arthritis, and chronic kidney failure. Its guidelines offer an excellent model for comparison. 

This 90-minute online course will give you the tools to bring your products to market in a swift and compliant manner.  Examples of successful and unsuccessful submissions will be discussed, as well as major differences between US and EMA regulations and World Health Organization (WHO) guidelines.

Benefits of attending

Attendees will learn:

  • The current global regulatory landscape:  Major differences in regulations
  • How to address Chemistry, Manufacturing & Control (CMC) regulatory challenges
  • Key factors when deciding between a biosimilar vs. a biobetter
  • Assessing biosimilarity and interchangeability
  • A case study: What one company learned from their competitive strategy

Who should attend?

This course will be beneficial to anyone working in biosimilar development that needs an understanding of the current and expected regulatory landscape.  Personnel in regulatory affairs, R&D, quality, and compliance will find this course particularly useful.

 

Time: 1pm - 2:30pm EDT

Duration: 90 Minutes - Online

Price: $299 - Introductory Rate

Company Spotlight

ImmunoGen

ImmunoGen

Affymetrix

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Affymetrix is considered a leading provider of microarray-based products and services to the global research community.

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