Biosimilars - An In-depth Analysis of the New EU Guidances and FDA’s Regulatory Requirements for the Manufacturer and Developers of Biosimilars
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>
Available Live On-Demand
After decades of discussing how to regulate generic biologics, agencies in Europe and the USA have finally released the long awaited requirements. We all knew it would not be as simple as small molecular weight drug generics but it has become clear in Europe and finally is becoming clear in USA. While the regulations read in a simple manner, the pathway to success is becoming clearer. There are many challenges still to be addressed that are not described in the regulations but implied in their wording. Some of these challenges including assuring the imitator is comparable to the innovator with respect to chemical characterisation, that the new manufacturing process does not lead to an unacceptable product, that efficacy, safety including immunogenicity is assured as well as demonstrating they are interchangeable in the approved indications (all with new guidances in the EU). What is very clear in the regulations is that some clinical trials in humans are required but exactly how many and how complicated is not spelled out. Even the FDA has realized that dialogue between companies and the agency is critical to assure a smooth development program with no surprises and so has a guidance for communication and negotiation. In 2014, with over 25 products on the market, the EU has issued further guidance on choice of comparators and has indicated that all you have to demonstrate is that it works for one condition and you get the others of the innovator as a bonus. The USA FDA, although well behind Europe, is poised to approve the first biosimilar by Sandoz, the generic arm of Novartis – filgrastim, the biosimilar to Amgen’s Neupogen.
In this webinar, we will present the regulations governing these generic or biosimilar biologics, what they actually say and require and the subtleties behind what is said and not said. We will describe the challenges that must be addressed in order to meet the spirit as well as the detail of the regulations and guidances. We will use various case studies of molecules to describe strategies that will address these specific challenges and describe where the risks are. We will compare these different challenges versus the small molecular weight generic approval process to illustrate the magnitude of the challenge and risk. We will describe how chemical characterisation, efficacy and safety are demonstrated for the biosimilar versus the innovator. And what types of clinical trial in human may well be required although it will be on a case by case basis after negotiation with the agency.
The instructor has been involved in biosimilars for over 2 decades while working at companies developing or contemplating developing biosimilars and representing them in interactions with the agency via trade associations.
- What the new regulation in Europe and the USA say must be done
- What the regulations mean directly and indirectly – what is said and what is implied
- Understand the challenges of meeting the regulators expectations
- What the risks are in embarking on a program for development and commercialization of biosimilars – why some are riskier than others
- What the potential payback for these lucrative molecules is
- How the various categories of molecules are different and what strategies will work for one but not another
- How to avoid going overboard and doing too much for approval
- How to demonstrate chemical, efficacy and safety comparability
Regulations that will be Covered: Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the Process Validation program:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH Q7a, 8, 9, 10 and 11.
Adopted February 2014 Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1).
Adopted February 2014 Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (draft).
Adopted October 2014 Rev 1 Guideline on similar biological medicinal products.
Adopted December 2014 Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|9:40 AM||What are the pathways for generic drugs,|
|How the new biosimilar regulations are formulated,|
|What they are implicitly requiring,|
|What is not said,|
|The various biological products and their challenges,|
|Chemical characterisation and the challenges,|
|10:40 AM||Comparability in manufacturing,|
|Process control and finished product testing,|
|In vivo comparability,|
|The case for bioavailability,|
|How to address safety,|
|The economic return on investment,|
|Conclusions and the path forward,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management
- Quality Assurance personnel and management
- Quality Control personnel and management
- Process development scientists and management
- Manufacturing management and scientists
- Regulatory Affairs Professionals
- Project Managers working in the CMC arena
Instructor: Peter Calcott Ph.D.
Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>
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