Bioequivalence studies are going to change the face of Pharma industry in Pakistan-Prof. Nadeem Rizvi


ANPLAG Bioequivalence study by PharmEvo
Bioequivalence studies are going to change
the face of Pharma industry in Pakistan-
Prof. Nadeem Rizvi
Anplag Bioequivalence with innovator is the first
study by PharmEvo and more such studies are
planned- Nadeem Rehmat
We will maintain high standard of our products
at all times-Syed Jamshed Ahmed

KARACHI: Appreciating the initiative taken by PharmEvo Pharmaceuticals to conduct a bioequivalence study of their product Anplag (Ticagrelor) an anticoagulation agent with the innovator, Prof.Nadeem Rizvi a renowned interventional cardiologist has remarked that such studies are going to change the face of Pharma industry in Pakistan. If this trend of bioequivalence studies continues, some people who have come into this industry just to make profit and do not believe in making any investment to modernize their manufacturing facility to maintain quality will be gradually eliminated. He was speaking at a function organized by PharmEvo at its drug manufacturing facility at Port Qasim Industrial Area to celebrate the results of their first bioequivalence study of Anplag with the innovator Brilliant produced by AstraZeneca in Sweden.

Prof. Nadeem Rizvi an eminent interventional cardiologist was the chief guest at the
ANPLAG Bioequivalence study celebrations organized by PharmEvo Pharmaceuticals at
its manufacturing facility on March 25th 2021. Group photograph taken on the occasion
shows him photographed alongwith Mr. Haroon Qasim Managing Director, Syed Jamshed
Ahmad Deputy CEO, Mr. Nadeem Rehman Chief of Plant operations alongwith other
senior executives of PharmEvo after the ceremony.

Continuing Prof. Nadeem Rizvi said that he knew PharmEvo when they conducted their clinical comparative study of LowPlat with Plivax in 2003 at NICVD. While one can wait to see the safety and efficacy of other drugs like antihypertensive to lower blood pressure, in case of blood thinner agents, one cannot wait as a clot formation could lead to heart attack which can prove fatal. In those days they invested about eight lac rupees in that comparative study which was a big amount at that time and since then he has been using LowPlat. I also use Avsar without knowing that it was a PharmEvo product because it works. He laid emphasis on transparency by the healthcare professionals and being mindful of conflict of interest while dealing with pharmaceutical companies. He further stated that an effort should be made to bring bioequivalence studies to Pakistan from the developed world where it is very expensive but will be quite cost effective in Paksitan once we have achieved that expertise. However, we must ensure that everything this is done scientifically. There are many silent Heroes who work behind the scene than those who come and speak on the stage and get applause hence their dedicated efforts and devotion to their work needs to be appreciated, he remarked.

Syed Jasmshed Ahmad Deputy Chief Executive Officer of PharmEvo in his speech commended the team who was involved in this bioequivalence study and said that it will further improve the image of the company. Pharmaceutical companies make tall claims but these claims need verification. When we conducted the clinical comparative study of LowPlat with Plivax in 2003 at NICVD, Prof.Azhar Farooqui the then Director of the institution had certain reservations but on persuasion he agreed but said that they will buy LowPlat and Plivax from the market to which we agreed and arranged the required funding. When the results came, he was pleasantly surprised to see it and got convinced of our claims of producing quality drugs. Again when the problem with Valsartan started, we in PharmEvo recalled all the stock from the market and replaced it with fresh products which cost the company almost eight crore rupees. The first year was very bad for us but then in a year’s time we regained our market share. We not only talk about ITREE our core values but also practice it. We will maintain high standards and our claims will always be validated. We are extremely careful because we are dealing with life and death of the patients. He congratulated the whole factory team saying that we transfer confidence to the medical profession on your behalf.

Earlier Dr. Masood Jawaid Director Medical Affairs PharmEvo gave details of the Anplag bioequivalence study. He pointed out that bioequivalence means that the drug must behave within the body in the same way as its innovator. Though there are no regulatory requirements for such studies in Pakistan, but we in PharmEvo did this on our own. Anticoagulation has a very short therapeutic window. He then referred to the drug concentration in plasma and opined that it is extremely important that the patient is in safe hands. The drug used was 90mg under fasting conditions and the study was conducted as Center for Bioequivalence Studies and Clinical Research at University of Karachi. The study protocol was approved by the University of Karachi Institutional Review Board, by National Bioethics Committee and by DRAP as well. This was a single center cross over study and all study subjects were randomized. One group got the reference drug and the other got Anplag. There was a wash out period of seven days in between. Blood samples were drawn eighteen times and thirty six samples were taken from each study subject. We started with one hundred fourteen subjects and when Covid19 Pandemic started, antibody tests were done four times of each subject. In the end twenty nine subjects completed the study. They stayed in the Ward for forty eight hours. They were all paid and their insurance was also arranged. The results showed that in all the three parameters Anplag was as effective as the innovator. Quality, he opined is never an accident but it is the result of intelligent effort and we are proud of our team at the manufacturing facility who was able to achieve all this, he remarked.

Mr. Nadeem Rehmat Chief Operating Office at the PharmEvo factory speaking at the occasion highlighted the concept of Quality Par Excellence which they try to achieve in their products. Bioequivalence means that the drug ensures therapeutic equivalence as well as pharmacological equivalence. There are many factors which affect pharmaceuticals which include the dosage form, drug intake, physiological chemical properties. Then there are certain environmental factors which affect quality of the product which include water, compressed air and HVAC. Particle count also matters. One has to be extremely careful about cross contamination while particle size of the API is also important. It is the people working in product development, process design, control design and material design which make a strong team who then make it possible to ensure quality into the products. This is the first bioequivalence study and in the days to come we are planning to have many more Class-IV products Bioequivalence studies, he added.

Mr. Bilal Hussain from Quality Operations at PharmEvo said that we never compromise on safety of patients. We dream a healthier society and to serve our patients, we are working day and night. We provide evidence of quality products. We tested it at our Chemistry Laboratory and then at the Karachi University Laboratory. Many people work in the drug development and testing is important. Precision and quality both are important in Vitro and In Vivo studies. One has to compare the product with the Reference product. In our study we followed the FDA guidelines. Dissolution profile was compared. We have tested this drug in the population which will be taking this drug and the study findings proved that it was as effective as the innovator Brilenta produced by Astra Zeneca in Sweden.

Mr. Sohaib Rashid welcomed the guests and the participants saying that it was a moment of pride for all of us and we have proved that we supply the highest quality drugs in the market. We sell our trust to the patients.

Mr. Haroon Qasim Managing Director of PharmEvo in his vote of thanks also referred to the clinical comparison study of LowPlat which PharmEvo had conducted in 2003 and said we always believe in quality. We aspire for quality as we wish to make a difference. Our initiative, he hoped, will encourage other Pakistani Pharmaceutical companies to go for bioequivalence studies. We need to ensure quality and bioequivalence studies are the established global quality parameters. We in PharmEvo never compromise on quality parameters. He thanked the entire team who participated in this project and opined that we can offer this to the global market to do bioequivalence studies and it will further enhance the image of the national pharmaceutical industry, he remarked.

The function concluded with the cake cutting ceremony. The programme was moderated by Ms. Asma Eric from product development.

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