Beximco Pharmaceuticals has recently got approval from the Food and Drug Authorisation (FDA) of the United States of America for one of their drugs Baclofen (10 and 25 mg tablets). (It is a muscle relaxant drug used for the treatment of muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.)
According to their press release on Monday, this is the ninth Abbreviated New Drug Application of the Pharmaceuticals fully developed in-house and successfully approved for the US market. The company's oral solid dosage facility was approved by the US FDA in June 2015.
The FDA approvals require a range of regulatory frameworks. For this, FDA checks the company's audit and annual reports, the quality of their products etc. Unless the quality is very high, it is tough to get FDA approvals. So it's a huge achievement for Bangladesh as the country's top pharmaceuticals company Beximco has earned this.
Today we have with us Rabbur Reza, the Chief Operating Officer (COO) of Beximco pharmaceuticals to talk about the achievement and the journey behind this.
Inam Ahmed: What was the process behind this achievement? What kind of hurdles did you have to go through to get this?
Rabbur Reza: Thank you for your wonderful introduction. I agree that it is really tough to take a medicine to the American market. Unlike readymade garments, medicines are life-saving components and the FDA takes it very seriously. They give approvals to medicines only after multiple rigorous processes.
Let me give you a brief background on how we got the approval. First, we must have FDA accreditation for the manufacturing sites where the medicines will be produced. And we are the first company in Bangladesh that got the accreditation in 2015 for our site where we produce our tablets and capsules. We have been trying to get that accreditation even before that as the USA is the biggest medicine market in the world. And now that we have got it, it proves how far our pharmaceuticals industry has risen.
After getting the accreditation in 2015, it is our 9th product that has been approved by the FDA. The products are developed, manufactured and packaged here in our facilities.
We have a Research and Development centre where 130 scientists are working. And it is not just for the USA, here we develop products for Bangladesh and other countries of the world as well.
So these are the initial things that we had to ensure. And it is not just about financial investments, we have human capital investments here. If we can develop skilled manpower, we can enter any market of the world. Now that we have entered the USA market, we are capable of developing products for the markets of Europe, Australia, New Zealand, Singapore, Malaysia, Africa.
So I think our R&D was a breakthrough for Bangladesh.
You have worked in an Australian biotech company and then you came to Bangladesh. So are there more passionate people like you who have left their job abroad and came here to join with you?
RR: We have 130 scientists working in our R&D centre. Among them a few, three/four are expatriates. But most of them are Bangladeshi scientists who have come back to Bangladesh to work here in the local industry. We even have people who just completed their graduation or higher studies like PhD from abroad and came back to Bangladesh to join us.
Besides, we needed to build up our strength in regulation also. For example, when R&D works to develop a product, all the data needs to be filed to the FDA. This takes a lot of intellectual inputs and we had to develop that skill as well.
These are the basics that we did to get into the developed pharmaceuticals market. Because Bangladesh has a self-sufficient pharmaceuticals market that can produce 98% of its medicines and pharmaceuticals products at home. But we always had an aspiration to get into the foreign markets as well so that like the RMG, it can grow as a profitable industry for us.
Although if we compare with garments and other export industries, we haven't done much in the pharmaceuticals – but this is the beginning. And getting to the US market was a huge step for us because out of a global pharmaceutical market worth $1.3 trillion, the United States alone has a $527bn market where the generic market (that we belong to) is $130 bn in the US.
We definitely must secure a place in the Asian and African markets. But if we want to gain a volume, our pharmaceuticals products must penetrate the markets of the USA, Japan, Australia, and Europe.
So you can call this a beginning. We started in 2015, nine of our products got approval from the FDA and currently, we have seven products in the USA market.
What is the amount of your export of these seven products? How is the growth?
RR: The seven products that we export to the USA covers around 40% of our total export. And the growth is also good.
But we also had some ups and downs, some challenges due to Covid-19. If we talk about the challenges, then I must say that the US market is very price-sensitive. Mainely three pharmaceutical companies control the US industry. So price and delivery timing are the two major factors to be successful in the USA market.
Are there any other companies or factories in Bangladesh that got the FDA approval like you?
RR: Yes. Square is another company that has FDA approval.
When you say that you have developed the medicine yourself, what do you mean by that?
RR: See, we are a generic pharmaceutical company, we are not innovators. Baclofen- the medicine that got FDA approval was originally innovated by Novartis (a Swiss multinational pharmaceutical company).
What we do in our labs is reverse engineering so that we get the same quality and efficacy. And we have to do some clinical trials and bioequivalence studies (exactly the same as the originator) to prove if the drugs are reacting the same way as the original medicine in a human body.
So, first we did a bioequivalence test in our lab, then we had a clinical trial and after that, we compiled all the data to file to FDA. We filed it in December 2019. So you can see, from originating a product to getting to the market- it's a long process, almost three to five years.
What was your clinical trial on? We had a controversy on primates and monkeys in the country. While the USA itself banned medicinal trials on primates, China and Japan go with that kind of trial.
RR: When innovator drugs are developed, mammals like mice, guinea pigs, non-human primates etc can be used for some modelling. More or less, these kinds of trials are used for biological drugs like a vaccine.
But as we are a generic company, not an innovator one, our trials are on humans to prove whether these drugs are giving the same efficacy as the original drug or not. And for that, we trail on around 132/200 human beings.
Did you have to give royalty to Novartis for this?
RR: No. As the drug is patent-free, we didn't have to give any royalty to the innovator company Novartis. But Baclofen is a Reference Listed Drug (RLD). As a generic company, we have to compare against RLD. Novartis hasn't exported the medicine to the USA for quite some time now. After Novartis, Teva was the first generic company that launched that medicine to the USA market. The FDA suggested we take the medicine that Teva produced as RLD and we did our comparative study or bioequivalence against that one.
Baclofen is a muscle relaxant drug. The other eight medicines of Beximco that got FDA approval, what kind of drugs are they?
RR: Those are mostly cardiac drugs. We have Carvedilol, Sotalol and Nadolol- these three are cardiac drugs. We have Metformin for diabetes and an antihistamine drug named Cyproheptadine mainly for allergies.
Metformin is widely used in Bangladesh and we are exporting it as well.
You said getting FDA approval opens up the pharmaceuticals market of Europe, Australia and other developed countries. Are you exporting to Europe?
RR: We export our drugs to Europe, Australia and Canada. But we have to get separate approvals for each one of them. And the process is the same, we have to get approvals for both of our manufacturing sites and products.
It has been quite sometime now that we are said to have a self-sufficient pharmaceuticals industry. Then why is it taking us such a long time for a big jump? Do we need some kind of regulatory backing? What are the real challenges here?
RR: The big jump will eventually happen. Slowly but surely we have started to go to the big markets already. But Beximco alone can't bring that much revenue, we will need more companies for that. And when 5/7 companies get to the worldwide pharmaceuticals market, you will see a fabulous increase in the overall figure.
And what we did was we chose small markets with small demand, slowly we have risen our capacity. After five years, we will be able to bring bigger brands and products that will bring us a few hundred billion dollars' profits. So other companies must come forward to meet that need and capacity.
A few years back, Beximco said that they are bringing medicine for AIDS. What about that? Is that in the market yet?
RR: Yes, we have that in the market and we have the pre-qualifications of the WHO. Our primary goal was to make that easily accessible for the HIV patients of our country. We didn't opt for the global market. For the last 15 years, we have been supplying that medicine to our HIV positive patients.
What is your next big plan?
RR: During the pandemic, you know how our pharmaceuticals industry has supported the country. Even when the developed countries were struggling to tackle the situation, Bangladesh, from the very beginning, worked on sourcing Covid-19 related materials like PPE, masks etc and our pharmaceutical industry played a big role in it. And there were medicines in different countries that were thought to be working against the virus, like Remidisivir. We immediately brought those medicines to Bangladesh. That shows the capability of the industry.
We say that Bangladesh has an 'almost' self-sufficient pharmaceutical industry. If we want to be self-sufficient, we would have to start with biological drugs like vaccines. From small molecular drugs like tablets and capsules to large molecular drugs like vaccines and biosimilar – we have to build capacity and get to a leadership position.
We started with the low-hanging products in the international market because we do not have backward integration yet. We still depend on third-party countries and companies for raw materials or Active Pharmaceuticals Ingredients (API). If we want to reach for the higher stands, we must approach this sector aggressively.
Does Bangladesh produce API?
RR: Very little. Around 8-9% of our total requirements. We have to import the remaining 90% from other countries.
Why aren't any investments here? Isn't it a good field for investment?
RR: The investments have already begun. There is an API park where companies have already started investing. In the next few years, I believe companies will start producing API. And in the meantime, we have already started working with some high-value patent medicine. During this pandemic, we have launched some products made with our API. So big things are coming up.
Another thing is the bio-molecular trials. We have started collaborating with our universities as well.
So it is a multi-dimensional industry – some companies will go to the big markets, some others will invest in API. We will have bio-molecular trials, collaborations with universities. We need research and development centres and quality skilled manpower. If we can assimilate all these puzzles together, I strongly believe that our pharmaceuticals market has tremendous potential for the export market.