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

April 01-02, 2020

13th European Biosimilars Congress 2020

London, UK
April 27-28, 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

30th Annual European Pharma Congress

Berlin, Germany
May 29-30, 2020

14th World Drug Delivery Summit

London, UK
June 24-25, 2020

6th World Congress on Medicinal Plants and Marine Drugs

Amsterdam, Netherlands
June 24-25, 2020

25th International Congress on Pharmaceutical Biotechnology

Amsterdam, Netherlands
June 29-30, 2020

12th World Congress on Neuropharmacology

Athens, Greece
July 22-23, 2020

23rd Asia Pacific Pharma Congress

Melbourne, Australia
July 29-31, 2020

Global Pharma Summit and Expo

Shanghai, China
August 26-27, 2020

33rd World Congress on Pharmacology

Barcelona, Spain
September 07-08, 2020

Global Summit on Generic Drugs and Quality Control

Prague, Czech Republic
September 09-10, 2020

World Pharma Expo

Amsterdam, Netherlands
September 10-11, 2020

World Congress on Rare Diseases & Orphan Drugs

Prague, Czech Republic
September 14-15, 2020

16th Annual Congress on Pharmacology and Toxicology

Vienna, Austria
September 16-17, 2020

Global Pharmacovigilance And Clinical Trials Summit

Shanghai, China
September 18-19, 2020

International Conference on Pharmaceutical Chemistry

Dubai, UAE
September 21-22, 2020

21st International Pharmaceutical Conference and Expo

Perth, Australia
September 21-22, 2020

35th World Pharmacology and Toxicology Forum

Tokyo, Japan
September 22-23, 2020

6th Annual Congress on Clinical & Hospital Pharmacy

Singapore City, Singapore
September 24-25, 2020

20th World Congress on Advances in Pharmaceutical Sciences

Singapore, Singapore
October 05-06, 2020

International Congress on Drug Delivery

Auckland, Newzealand
October 15-16, 2020

nanomedicine-pharma-2020

Rome, Italy
October 21-22, 2020

20th Annual Meet on Pharmaceutical Sciences

Bangkok, Thailand
October 21-22, 2020

27th World Congress on Pharmacovigilance and Clinical Trials

Frankfurt, Germany
October 26-27, 2020

22nd International Conference on Drug Design and Development

Amsterdam, Netherlands
November 09-10, 2020

2nd World Congress on Drug Discovery and Drug Design

Tokyo, Japan
November 09-10, 2020

21st Global Summit on Analytical and Bioanlaytical Techniques

Amsterdam, Netherlands
November 9-10, 2020

Annual Meet on Pharmacovigilance & Drug Safety

Tokyo, Japan
November 09-10, 2020

20th Medicinal & Pharmaceutical Sciences Congress

Budapest, Hungary
November 09-10 , 2020

Asia Pacific Pharmaceutics & Drug Delivery Congress

| Tokyo , Japan
November 11-12, 2020

4th World Congress on Eye and Vision

Dubai, UAE
November 16-17, 2020

World Congress on Biologics and Biosimilars

Kyoto, Japan
November 19-20, 2020

Global summit on Cosmetic and Reconstructive Surgery

Tokyo, Japan
November 23-24, 2020

Pharma Expo China

Paris, France
November 23-24, 2020

Pharmaceutics & Novel Drug Delivery Summit China

Paris, France
November 23-24, 2020

21st Middle East PharmaTech & Expo

Istanbul, Turkey
November 25-26, 2020

8th World Congress on Antibiotics, Antimicrobials & Antibiotic Resistance

Singapore City, Singapore
November 26-27, 2020

11th World Congress on Bioavailability and Bioequivalence

Istanbul, Turkey
December 02-03, 2020

2nd International Conference on Bio-Pharmaceuticals

Auckland, Newzealand
December 07-08, 2020

International Liver Congress

Dubai, UAE
December 07-08, 2020

International Conference on Biotechnology and Healthcare

Auckland, Newzealand

Biosimilars Approval to Biogenerics in Clinical Practice Conference Speakers

Recommended Sessions

Related Journals

Are you interested in