As part of efforts to strengthen its regulatory oversight role regarding the use of high risk drugs in Guyana, the Government Analyst–Food and Drug Department (GA-FDD) recently participated in a workshop on the registration process associated with biologics and biosimilar-type drugs.
In a press release issued last week, the Department said that the workshop was hosted in its Boardroom with the 120-year-old Swiss Pharmaceutical and Diagnostic company (Roche), whose local representative ANSA McAL was instrumental in facilitating the interactive forum.
It was explained that improvements in the efficiency of the regulatory process for the Registration of Biologics and Biosimilars were discussed in detail.
The release said that biologics are drugs, mostly proteins produced from genetically modified living cells with a heterogeneous and highly complex molecular structure and since these products are derived from living cells, no identical copies of a biologic drug can be made. Further, it stated that biosimilars are very similar but not identical.
Facilitating the exercise was Roche’s Costa Rican-based expert on regulatory affairs, Maria Jose Meness Jimenez who focused on the characteristics of Bio-therapeutic products, the registration process for this category of pharmaceuticals and the importance of Pharmacovigilance in identifying Adverse Drug Reactions (ADR’s) linked to their post market use.
The Roche representative placed emphasis on the manufacturing of biologics, their biological complexity, the dangers associated with substitution and switching of medication and the need for pharmacists to be aware of changes in prescription.
According to the release, 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.
The meeting, the release said was informed that only Reference Biotherapeutic Products (RBPs) and their corresponding Biosimilars are evaluated in clinical and non- clinical studies. These Biologics therefore provide standalone data for safety, efficacy and quality. The use of Non-Comparable Biologics (NCB’s) was warned against 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 and the ease of electronic verification via official websites was also shared with the participants.
It was further explained that 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
Further, the release said that the Department in the recent past had cause to take legal action against the release of an unregistered biologic in the country’s 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 regulations and also checks revealed that clinical trials were not performed on the brand of drugs.
“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”, it added.
