Biosimilar Guideline 2016
Source : The Hindu
GS II : Health;
Overview
- News in Brief
- About Biosimilar Guideline 2016
Why in News ?
Health activists and patient groups seek revision of existing Biosimilar Guideline for increased access to critical drugs.
News in Brief
- Seeking immediate revision of Biosimilar Guideline (2016).
- Aims to facilitate access to quality biosimilars at an affordable price, representatives of various civil societies, community and health organisations, and patient groups have written to the Central Health Ministry and Department of Biotechnology
- Write to form a committee free from the influence of innovator biologic manufacturers who have a clear conflict of interest promoting the originator products which are exorbitantly priced and clearly out of reach of most Indian people.
- A biosimilar, or biosimilar drug, is a medicine that is very close in structure and function to a biologic medicine and is safe and effective treatment options for many illnesses including arthritis, kidney conditions, and cancer.
- They increase access to lifesaving medications at potentially lower costs.
About Biosimilar Guideline 2016
- Only an authorised reference biological that has been approved utilising a full data package may be used as the basis for developing a similar biologic.
- The reference biological should have been licenced, approved, and sold in a nation that is a member of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
- If the reference biological is not authorised in India.
- The eligibility requirements for conducting clinical studies on biosimilars are outlined in the Draught Guidelines.
- Phase III biosimilar trials must include at least 100 evaluable patients, whereas Phase IV trials require at least 200 evaluable patients.
- The patent on the original drug or product must have expired before the biosimilars may be produced and commercialised, much like other medications and formulations.
Guidelines
- Review Committee on Genetic Manipulation : The applicant must adhere to the RCGM criteria, such as showing that the process and product are consistent, as well as the product’s characterisation and standards.
- According to the CDSCO industry guidelines from 2008, the applicant must submit an application for the conduct of a clinical trial using the information provided in the preclinical application.
- The applicant should archive all the data for a period of at least 5 years after marketing approval by competent authority in India.
- Competent Authorities
- Genetic Engineering Appraisal Committee (GEAC)
- Central Drugs Standard Control Organization (CDSCO)
- Institutional BioSafety Committee (IBSC)
- Review Committee on Genetic Manipulation (RCGM)
Biologics: Biologics are medicinal products which are mainly composed of living tissues or cells. Include vaccines, blood and blood components, gene therapy, tissues and recombinant therapeutic proteins.
Biosimilar: A biosimilar is a biologic that has been found to be identical to another biologic. They increase access to lifesaving medications at potentially lower costs. It is a medicine that is very close in structure and function to a biologic medicine. It is safe and effective treatment options for many illnesses
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