Biosimilars: Preparing For Opportunities And Challenges
The Biologics Price Competition and Innovation Act (BPCIA) of 2010 ("Biosimilar Act") serves as FDA’s current framework for biosimilars, but there is a great of deal of confusion surrounding this legislation and regulatory pathways for approval.
Outside the US, the global market has already evolved. The European Medicine Agency (EMA) has approved several 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.
What can we learn from what has worked and what hasn’t?
This 90-minute online course will give you an inside look at changing regulations, approvals, uncertainties, and opportunities to shed light on how your biopharmaceutical business should best adapt its approach. 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.
By attending this interactive course, you will learn:
- How to address Chemistry, Manufacturing & Control (CMC) regulatory challenges
- The current global regulatory landscape: Major differences in regulations
- 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
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.
Dr. Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotheraputics with a proven 30+ year track record in biotechnology, pharmaceutical, and contracting industry, including positions at Centocor, Johnson and Johnson, and Charles River Laboratories.
Over his career, Dr. Rosenblatt has developed, transferred and validated purification processes for multiple new molecular entities through all stages of drug development, including licensure by the application of an innovative and comprehensive approach. This includes the licensure of a biological drug with current annual sales exceeding $6 billion. He has performed due diligence on Contract Manufacturing Organizations (CMO) including assessment of technical ability, and QA/regulatory status.
Dr. Rosenblatt currently serves as a CMC consultant to the Biopharmaceutical industry, covering originator molecules and biosimilars as well as Cell Therapy. He is experienced in international regulatory submissions (IND, CTX, and BLA) and is a special invitee member of Pharma Research and Development Association (PRADA) Global.
Dr. Rosenblatt ‘s Academic credentials include a BA in Biochemistry from Columbia University, NY, NY, and Ph.D. in Cell Biology/Microbiology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.