Innovative Clinical Approach in Biosimilars


Clinical trials for biosimilars must exhibit practically identical security what's more, viability to the reference item, including consecutive PK/ PD and viability/security trials. Controllers expect PK/PD similarity information from a Phase I trial will bolster encourage viability/ wellbeing evaluations in crucial Phase III trials. Remain solitary Phase III investigations or joined Phase I/III outlines without supporting PK information are probably not going to be acknowledged. Clinical similarity prerequisites may fluctuate on a case-by-case premise subject to a risk based approach. Three-arm Phase I trials are progressively being used to show equivalence between the biosimilars and two authorized adaptations of a similar reference item that may exist in various markets, allowing developers to proceed with pivotal trials using a single version of the reference product


  • Clinical PK/PD studies
  • Toxicological studies
  • Risk management and quality affairs
  • Targeted cell line development
  • Case studies and clinical models
  • Biologics product life cycle and sustainable market returns
  • Biosimilars clinical trials

Related Conference of Innovative Clinical Approach in Biosimilars

June 21-22, 2021

1 st Global Summit on Generic Drugs and Quality Control

Prague, Czech Republic
June 24-24, 2021

1 st Pharmaceutical and Pharma Industry

London, UK
June 25-25, 2021

4thPharmaceutical Research and Drug Discovery

Singapore City, Singapore
June 25-25, 2021

Pharma 2021

London, UK
June 26-26, 2021

3D Priniting

Chicago, Aland Islands
July 06-07, 2021

14th Global Pharmacovigilance And Clinical Trials Summit

Albufeira, Portugal
July 10-11, 2021

2 nd Pharma Expo China

Tokyo, Japan
July 13-14, 2021

24th Asia Pacific Pharma Congress

Melbourne,
July 26-27, 2021

36th World Pharmacology and Therapeutics Forum

Paris, France
July 30-30, 2021

12th World Congress on Bioavailability and Bioequivalence

Prague, Czech Republic
August 16-17, 2021

Global summit on Cosmetic & Reconstructive Surgery

Tokyo, Japan
August 16-17, 2021

34rd World Congress on Pharmacology

London, UK
August 23-24, 2021

7th World Congress on Medicinal Plants and Marine Drugs

Prague, Czech Republic
August 25-25, 2021

7th International Conference on Surgeons

London, UK
August 30-31, 2021

20th Medicinal & PharmaceuticalSciences Congress

London, UK
September 13-14, 2021

3rd World Congress on Drug Discovery and Drug Design

Tokyo, Japan
September 17-18, 2021

9th International Conference on Clinical Trials

Montreal, Canada
September 20-21, 2021

Asia Pacific Pharmaceutics & Drug Delivery Congress

Tokyo, Japan
September 27-28, 2021

2 nd World Pharma Expo

Tokyo, Japan
October 05-06, 2021

International Congress on Drug Delivery

Auckland, Newzealand
October 21-22, 2021

2nd Annual Congress on Antibiotics and Bacterial Infections

Geneva, Switzerland
October 29-30, 2021

12th Annual Biomarkers and Clinical Research Congress

Vancouver, Canada
November 01-02, 2021

15th World Drug Delivery Summit

Rome, Italy
November 16-17, 2021

World Congress on Biologics and Biosimilars

Osaka, Japan
November 26-27, 2021

World Biosimilars & Biologics Congress

Vancouver, Canada
December 02-03, 2021

17th Annual Congress on Pharmacology and Toxicology

Tokyo, Japan
December 02-03, 2021

International Conference on Bio Pharmaceutics

Auckland, Newzealand
December 07-08, 2021

2nd International Conference on Biotechnology and Healthcare

Auckland, Newzealand
December 15-16, 2021

12th World Congress on Bioavailability and Bioequivalence

Bali, Indonesia

Innovative Clinical Approach in Biosimilars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in