Regulatory Approach for Biosimilars

Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of  biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars regulatory prospects of BRIC countries, a paradigm of traditional generics to Biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. Biosimilars 2018 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics with a clear picture of the regulatory approach for biosimilars and biologics.

 

  • Licensing of biosimilars
  • Biosimilars regulation
  • BLA filing for biosimilars
  • Regulatory prospects of BRIC countries
  • A paradigm of traditional generics to biosimilars
  • Biowaiver approval for Biosimilars
  • Generic Biosimilars
  • BLA filing for biosimilars

Related Conference of Regulatory Approach for Biosimilars

July 21-22, 2025

11th International Conference on Antimicrobials & Antibiotic Resistance

Vancouver, Canada
July 21-22, 2025

28th World Congress on Nursing, Pharmacology and Healthcare

Barcelona, Spain
July 24-25, 2025

5th World Congress on Cardiovascular Medicine Pharmacology

Paris, France
August 18-19, 2025

40th World Congress on Pharmacology and Therapeutics

Valencia, Spain
August 21-22, 2025

5th International Conference on Pharmaceutical Chemistry

Dublin, Ireland
August 25-26, 2025

11th International Conference on Pharmaceutical Regulatory Affairs and IPR

Vancouver, Canada
September 08-09, 2025

26th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

Frankfurt, Germany
September 08-09, 2025

13th International Conference and Exhibition on Natural Products and Medicinal Plants Research

Frankfurt, Germany
September 15-16, 2025

42nd International Conference on Drug Discovery and Drug delivery system

Paris, France
September 19-20, 2025

18th World Drug Delivery Summit

Paris, France
September 22-23, 2025

Pharma Biotech Expo

Toronto, Canada
September 22-23, 2025

20th International Conference on Pharmaceutical Formulations & Drug Delivery

Toronto, Canada
September 23-24, 2025

10th International Conference on Future Pharma and Innovations

Amsterdam, Netherlands
October 16-17, 2025

18th International Conference on Pharmaceutics and Drug Safety

Berlin,
October 22-23, 2025

7th European Conference on Advance Clinical Trials and Research

Paris, France
November 13-14, 2025

28th International Conference and Exhibition on Pharmaceutical Formulations

Paris, France
November 13-14, 2025

21st International Conference on Pharmaceutical Chemistry

Aix-en-Provence, France
November 20-21, 2025

21st Annual Congress on Pharmacology and Toxicology

Paris, France
November 27-28, 2025

4th World Congress on Precision and Personalized Medicine

Zurich, Switzerland
November 27-28, 2025

4th World Conference on Pharma Industry and Medical Devices

Zurich, Switzerland
November 27-28, 2025

13th International Conference on Clinical Trials

Amsterdam, Netherlands
January 28-29, 2026

23rd International Pharmaceutical Sciences & Life Saving Drugs

Bangkok, Thailand
February 23-24, 2026

17th Global Pharmacovigilance & Clinical Trials Summit

London, UK
February 23-24, 2026

3rd World Congress on Biologics and Biosimilars

London, Aland Islands
April 27-28, 2026

9th European Biopharma Congress

Paris, Aland Islands

Regulatory Approach for Biosimilars Conference Speakers

    Recommended Sessions

    Related Journals

    Are you interested in