Biosimilars Approval to Biogenerics in Clinical Practice

Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a biosimilars. According to current literature, the following points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to allow physicians to gain confidence in biosimilars.

  • Biotechnologic drug
  • Monoclonal antibody
  • Fusion protein
  • Biologic drug
  • Anti–tumor necrosis factor

Related Conference of Biosimilars Approval to Biogenerics in Clinical Practice

August 19-20, 2019

24th World Congress on Pharmacology

Vienna, Austria
September 11-12, 2019

14th World Congress on Pharmacology and Toxicology

Singapore
September 11-12, 2019

World Congress on Drug Discovery and Drug Design

Singapore
September 25-26, 2019 Hong Kong

17th World Congress on Drug Formulation & Drug Delivery

Courtyard by Marriott Hong kong
October 07-08 2019

Global Congress on Pharmacology and Therapeutics

Paris, France
October 07-08, 2019

Innovation in Drug Design Techniques and pharmacology

| Paris, France
October 10-11, 2019

15th World Congress on Medicinal Chemistry & CADD

Dubrovnik | Croatia
October 14-15, 2019

19th World Congress on Advances in Pharmaceutical Sciences

Seoul, South Korea
Oct 23-24 2019

11th Annual Biomarkers and Clinical Research Congress

| Amsterdam, Netherlands
October 25-26, 2019

14th International Conference on Biopharma and Biotherapeutics

| Copenhagen, Denmark
October 23-24, 2019 | Copenhagen, Denmark

12th Pharma Congress

November 04-05, 2019

Advanced Pharmaceutics and Clinical Research

| Paris, France
September 11-12, 2019

2nd Annual Pharmaceutical Biotechnology Congress

Singapore
November 11-12, 2019

20th Annual Pharma Middle East Congress

Istanbul, Turkey
November 18-19, 2019

European Congress on Nanomedicine and Pharmaceutical Nanotechnology

Prague, Czech Republic
November 18-19, 2019

European Conference on Pharmacovigilance & Drug Safety

Prague, Czech Republic
November 18-19, 2019

27th Global Experts Meeting on Neuropharmacology

Rome, Italy
November 19-20, 2019

20th Annual Meet on Pharmaceutical Sciences

Bangkok, Thailand
December 02-03, 2019

15th Annual Congress on Pharmacology and Toxicology

Paris, France
March 23-24, 2020

23rd Asia Pacific Pharma Congress

Singapore
April 01-02, 2020

13th European Biosimilars Congress 2020

London, Uk
April 22-23, 2020

5th Pharmaceutical Chemistry Conference

Prague, Czech Republic
April 27-28, 2020

7th European Biopharma Congress

Prague, Czech Republic
May 06-07, 2020

15th Annual Meet on Euro Ethnopharmacology

Prague | Czech Republic
May 18-19, 2020

22nd Annual European Pharma Congress

Berlin, Germany

Biosimilars Approval to Biogenerics in Clinical Practice Conference Speakers

Recommended Sessions

Related Journals

Are you interested in