Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.
There is a misconception that they are similar to or are the same as generics, but this is not so in reality. Generics differ from a biosimilars in one major sense: While a biosimilar is only highly similar to the original product (called the reference product); a generic is the exact replica of the original, whose chemical structure it takes. Further, there is a difference in the ways they are manufactured, their complexity (generics are small and biosimilars, big), and the data each is required to furnish for gaining approval.
The regulatory requirements for gaining approval for biosimilars are considered complex. Different approaches are used in different regions around the world.
Exploration of all aspects of biosimilars
Professionals in the areas of biological sciences, who deal with biologics, need to have complete knowledge of the whole host of issues associated with biosimilars, ranging from their manufacturing process to regulatory guidelines. Given the complex nature of the science and the approval process; lack of in-depth knowledge can result in their application getting rejected by the regulatory authorities.
It is to help avoid these situations that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar. The aim of this seminar is to offer complete understanding of the topic of biosimilars, from its clinical aspects to what it takes to gain approval, and a whole host of other issues relating to biosimilars.
The Director of this seminar is Salma Michor, Founder and CEO of Michor Consulting Schweiz GmbH. Salma teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor Consulting Schweiz’s clients include Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. To gain the immense benefits this seminar offers, please register by visiting All about biosimilars –from development to registration This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Discussion of all the areas relating to biosimilars
The FDA’s approval process for biosimilars is quite complex. If a biosimilar product has to gain FDA approval, it has to show that it is highly similar to an FDA-approved reference product. It has to show that the biosimilar product has no substantial deviation from the reference product in terms of effectiveness and safety. If there are differences, the company has to show that these are within the permissible limits allowed for the product.
The Affordable Care Act of 2010 made a few amendments into the way the Public Health Service Act (PHS Act) creates an abbreviated licensure pathway for biosimilars which are “biosimilar” to or are “interchangeable” with an FDA-approved biological product. This has to be in the manner described in the Biologics Price Competition and Innovation Act (BPCI Act).
An interchangeable biosimilar product is one that can be interchangeable with the reference product. That is, it can be substituted for the reference product without the advice of the prescriber. This means that the interchangeable biosimilar has met the FDA-approved reference product’s standards, as well as additional standards required for it to show interchangeability.
Complete understanding of the process relating to biosimilars
Over the two days of this seminar, Salma will help participants understand all the aspects relating to biosimilars. She will explain the challenges and choices that professionals in the field of biosimilars are up against. Biosimilar legislation in the US and the EU, the ways of establishing Target Product Profile (TPP) for a biosimilar, preclinical aspects, and quality, stability and preclinical testing will all be covered.
The Director will also lead participants into an exploration of the Phase I and Phase III clinical aspects relating to biosimilars, the existing guidelines on clinical testing and safety, registration process under the EMA, and market access for biosimilars in the US and Europe. She will intersperse these topics with relevant case studies.
This two-day seminar will offer value to those who deal with biosimilars in their work. These include Regulatory Affairs, Medical Officers and Clinical Trial Managers.
Salma will cover the following areas at this seminar:
- Design and TPP
- Pre-clinical testing and comparability
- Clinical testing
- Analytical studies
- Stability of biosimilar products.