Biosimilars 2019 will showcase the current year’s gathering on New Horizons in Biosimilars and Drug Delivery which will give a worldwide stage to talk about the present and future of Biosimilars and drug delivery. Biosimilars are neither generic medicines nor novel treatments. They are the biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (MAbs), playing an increasingly important role in global healthcare. The phenomenally complex manufacturing process involved in making biosimilars is really leading contemporary science in this field and could potentially revolutionize the treatment of some conditions.
Biosimilars versus generic drugs
Biosimilars and generic drugs are versions of brand-name drugs. But biosimilars are not generics, and there are important differences between biosimilars and generic drugs. Both biosimilars and generics are approved through different abbreviated pathways. The manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand name drug. Biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product. Biosimilars drugs should show there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness.
Key Discussions on Biosimilars 2019:
- Current regulatory status of biosimilar medicines in the EU Market access and regulatory developments
- Sustainability of the biosimilar medicines sector
- Advances and convergence of regulatory science
- Regulatory requirements, scientific and operational challenges
- Biosimilar Development and Manufacturing
- Pharmacovigilance Clinical Trials Legal Considerations on Biosimilars FDA-Approved biosimilar products
- Prescribing biosimilar and generics drugs
