The Government Analyst –Food and Drug Department (GA-FDD) commenting on a recent workshop hosted in the Department’s Boardroom with the 120 years old Swiss Pharmaceutical and Diagnostic Giant (ROCHE), said that improvements in the efficiency of the Regulatory Process for the Registration of Biologics and Biosimilars were discussed in detail.
Biologics are drugs, mostly proteins, produced from genetically modified living cells with a heterogeneous and highly complex molecular structure.
Head of the Government Analyst –Food and Drug Department, Marlan Cole, said that since these products are derived from living cells, no identical copies of a biologic drug can be made. This gives rise to Biosimilars which are very similar to the innovative or reference product but not identical.
Non-Comparable Biologics (NCB’s) on the other hand are copies of the innovative biologic drug that do not comply with World Health Organization (WHO) guidelines therefore they cannot be called Biosimilars.
Facilitating the exercise was ROCHE’s Costa Rican-based expert on Regulatory Affairs, Ms. Maria Jose Meness Jimenez. Representing the Department were the Director, the Deputy Director, Representatives from the Department’s Quality Assurance Unit, the Principal Analytical Scientific Officer, Head of the Drug Testing Laboratory and Drug Inspectors of the Department.
Topics covered by Ms. Meness Jimenez were the characteristics of Bio-therapeutic products, the registration process for this category of pharmaceuticals and the importance of Pharmaco vigilance in identifying Adverse Drug Reactions (ADRs) linked to their post market use.
The meeting was informed that only Reference Biotherapeutic Products (RBPs) and their corresponding Biosimilars are evaluated in clinical and non- clinical studies. These Biologics therefore provide stand alone data for safety, efficacy and quality.
The use of Non Comparable Biologics (NCB’s) was deprecated due to the absence of quality, safety and efficacy data. In addition to this they do not meet WHO guidelines nor are they authorized by any stringent regulatory agencies.
A practical demonstration of a Certificate of Pharmaceutical Product (CPP) issued by the US government for the Authorities in Guyana was done. Cole reiterated the Department’s regulatory requirement found in Regulation 78 of the Food and Drugs Regulations where Biologics and Biosimilars are currently classified as New Drugs.
The World Health Organization (WHO) provides guidelines and recommendations about how to evaluate a biotherapeutic medication. The nine Stringent Regulatory Agencies (SRA’s) that meet WHO stipulations for the evaluation of these drugs are: The European Medicines Authority; The United States FDA; The regulatory authority of Japan; The regulatory authority of Switzerland; The regulatory authority of Canada; The regulatory authority Iceland; The regulatory authority of Norway; The regulatory authority of Liechtenstein and The regulatory authority Australia.
These agencies provide WHO recognized Certificates of Pharmaceutical Product (CPP). However, of the nine abovementioned stringent Regulatory Authorities the Food and Drugs Regulation mandates the recognition of CPP’s issued by the SRA’s of Canada, Australia, the United States of America or the United Kingdom.
Ms. Menses Jemenez placed emphasis on the manufacturing of biologic, their biological complexity, the dangers associated with substitution and switching of medication and the need for pharmacists to be aware of changes in prescription.
Also highlighted at the meeting between the Department and the ROCHE Rep. was the ease with which verification can be made electronically with official websites such as clinicaltrials.gov and https://www.ema.europa.eu/aamong others.
This was a very interactive meeting with the ROCHE representative as the Department was able to reiterate that we are legally bounded to recognize the certification and/or approval of four reference authorities before registering any Drugs. The Caribbean Public Health Agency’s (CARPHA)- Caribbean Regulatory System (CRS) pathway was also presented to the Company.
The Department in the recent past had cause to take legal action against the release of an unregistered biologic in our health care delivery system and has also had cause to recall the registration of one such product that was later found to be non-compliant with our regulation and also checks revealed that clinical trials were not performed on the brand of drugs.
ROCHE’s local representative, Ansa McAL, was instrumental in facilitating this interactive meeting/ Workshop.
Information received and risk associated with this class of drug will be taken into consideration by the Department as we seek to further strengthen our regulatory oversight on high risk drug release for use both in our national health care delivery system and in those that are private.