Regulatory convergence is extremely important

What is IGBA’s mandate?

IGBA is the International Generic and Biosimilar Medicines Association. The association is formally set up in Switzerland, and it’s the trade association gathering the associations of generic and biosimilar medicines across the world. So the setup is a little different from other associations in the sense that we don’t have any direct company membership, but our members are the various associations of the sector around the world, like the Indian Pharmaceutical Alliance (IPA), which is one of our members. 

We focus on discussing the topics that are relevant for our sector at a global level so IGBA does not dwell on the discussions of what’s happening at the national level but more like what are the global topics that are important for the generic and biosimilar sectors at a global level. We are a non-state actor with the WHO and we have official relations also with WTO, the World Trade Organization and the World Intellectual Property Organization (WIPO). 

What are the top trends that IGBA is observing and how are they going to impact the sector? 

Our industry is about access to medicines and we focus on any topic that can have an impact on how patients can access the generic and biosimilar affordable medicines. 

One of them is single global development. It’s connected to the idea that we need international reliance and convergence at the regulatory level because it fosters a predictable environment where the developers can develop their products and know that they will be able to register them across the world. Registration is a key step in the medicine’s life cycle, and from then onwards, the products can be available to treat patients on the market. 

But it’s quite interesting to note that unlike what happens with the originator products, where they have a single data package that can be used anywhere across the world with the same clinical trials and the same dose with minor adaptations, with the same clinical development programme. This is not possible for generic and biosimilar medicines and this is a key barrier right now in terms of the regulatory environment. If the studies that are required for registration of generic and biosimilar medicines need to be repeated, for example, to use the local reference product and knowing that in some cases the local reference product is going to be the same, this makes no sense. It’s delaying access to patients because it requires the unethical repeat of studies with no added benefit. 

Certain countries have accepted this concept. What has been their experience?

Some regulatory authorities around the world already accept the use of foreign comparator products, which is an enabler of single global development. One example of this is the countries in the Access Consortium, which are the UK, Singapore, Australia, Canada, and Switzerland. These authorities recognise that it’s not completely the same in all of them, but the general concept that in certain cases it might be possible to use a foreign comparator product is accepted. 

So I think one important message is that it would be desirable that all across the world, the same possibility would exist. It’s technically possible, we can define criteria. Sometimes there are barriers in the local legislation, but these barriers should be addressed. Because one very important point is that there is a bit of a misconception that developing a generic medicine is very easy, and this is not the case. The products are getting more complex.

In some cases, you need to perform studies on patients, and if you have to repeat these studies over and over again, just for the sake of using a local reference product, then you’re competing with yourself in terms of recruitment for the clinical trials. And in some regions, the product is going to get developed sooner, and in other regions, it will take more time. And while this is not available in those markets where the development will be later, the patients in those markets will not have access. 

So how do you address concerns about the same product going into different countries with different genetic profiles? 

Different populations might react differently to the active substance. If you look at the draft version of the ICH guideline on bioequivalence, there is no requirement to perform bioequivalence studies in different populations. The reason is because what you are doing in a bioequivalence study is comparing the reference product with the generic product in the same subjects. So if the active substance is reacting differently due to genetics or something else, you will see that in the originator product. (Update: The ICH M13A Guideline and associated Q&As on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” reached Step 4 of the ICH Process on July 23, 2024)

We are highlighting this point to the various regulators across the world. It’s really my pleasure to be here and be able to bring this topic to India. 

On another point about the harmonisation of bioequivalence, as I said, this is being developed at the ICH level, which means that the bioequivalence guidelines are developed jointly by a group of experts representing all of the ICH members. IGBA is a member of ICH, and it’s recently been re-elected as part of the Management Committee of ICH. 

Generic medicines play a critical role in the treatment of patients across the world. The largest proportion of treatment for prescribing prescription medicines in most regions is brought by generic and biosimilar medicines. So it’s only fair that we are part of the international discussion when, for example, these guidelines are being developed. And we were very happy to see our representatives at the Management Committee re-elected at the ICH meeting in Fukuoka, Japan.  

We feel that this is the recognition of the relevance that our industry brings to these discussions. It’s also the recognition of the hard work of the many experts that represent IGBA and all of these working groups that are developing new guidelines.  

What is the feedback that you’ve got from the Indian regulator and other regulators, from your recent engagements?  

This (in June 2024) will be the first engagement with India’s regulator. And I think maybe IPA has had the chance to discuss some of these topics that are IGBA priorities with the Indian regulator. 

There are multiple platforms at the international level where regulators come together to discuss these topics and this is extremely important because what’s driving decisions regarding the development of generics and any other drugs, is that they are scientific issues. 

So it should be possible to build consensus and make sure that there is a streamlined approach because streamlining the process based on science is the way forward. 

It makes no sense that each country is just looking at its reality and its own requirements. We saw a very important manifestation of how critical it is to work together during the pandemic.  There were issues related to access to certain drugs because there was an incredible surge in demand and during those times there was a lot of dialogue among the international regulators and a lot of work sharing. So it’s really the proof of concept that this can work if there’s early dialogue if everybody is at the table to discuss what’s the best way to do this. So it requires investment that people will come to the table and do the hard work. 

But in the end, it’s what makes sense. And that’s why regulatory convergence is extremely important because the basis of all this is science.  Science is an objective thing so it should be possible to come together and come up with a recommendation that everybody is going to follow.

There’s also a war for market share in the generic pharma industry. And we are seeing quality issues so how is your association going to address those issues, as the profit margins in generics are quite thin. This leads to a price war and at the lowest price, quality gets impacted. So how will you balance the interests of generic players in various countries?

You touch upon two very important things. This event (the IPA annual meet) is a very good example of what can be done to discuss the important aspect of quality because quality has to be built into the system; it’s not something that you add at the end. So having these discussions, I think is a very important piece of this puzzle. 

The other point that you mentioned that is very important throughout the world is the fact that the market needs to be sustainable. So focusing all of the discussions on what’s the cheapest price that we can get is not the right approach.  For a healthy thriving market, we need this market to be sustainable. 

And this is an important message that our members try to convey whenever they have discussions at their local levels. If we only focus on price, the market is going to decrease. Even if the end product is a quality one, there will be issues. For example, if there’s an issue with the supply chain, who else is there to provide the medicine? So I think a healthy environment, a sustainable environment, are very important pieces of this. 

There has to be a recognition of the value that generic and biosimilar medicines bring to the table. We need affordable care but we also need to make sure that it’s sustainable.

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