In 2009, the US Food and Drug Administration (FDA) accepted Mylan’s new drug application (NDA) for Brabio, the first generic version of Teva’s Copaxone for multiple sclerosis (MS). The 20mg/mL and 40mg/mL glatiramer acetate injections were launched in the US and the 40mg/mL version was approved in Europe in October 2017; the 20mg/mL had been approved previously.
Following this, Teva decided to appeal to the UK’s High Court of Justice, arguing its European patent for Copaxone was still valid. However, the court ruled in favour of Mylan and its European partner Synthonm, finding that Teva’s claims regarding the patent were ‘invalid based on obviousness’.
Teva then decided to take the case to the UK’s Court of Appeal, which rejected its request, meaning that Brabio was only launched in the UK in late January 2018, although it was already available across Europe.
Mylan’s UK country manager Jean-Yves Brault discusses Brabio, opportunities in the generics market and the challenges facing generic manufacturers working in the UK.
Allie Nawrat: Can you explain the process behind the development and approval of Mylan’s generic glatiramer acetate injection (Brabio) for MS?
Jean-Yves Brault: For this drug, Mylan decided to partner with Synton, which is a company with whom we have partnered with on many other projects.
There are two strengths of glatiramer in the UK, 20mg/ml and 40mg/ml. The second one, the 40mg, recently completed registration in the UK. It was approved centrally in October 2017 in the Netherlands and we launched it in the UK January 2018 under a national authorisation, so it is quite a recent launch in the UK.
Like in most situations where companies are about to lose their exclusivity, there are some legal discussions going on [regarding Teva’s recent challenge against Mylan over the former’s patent of Copaxone in the UK].
The decisions are made by the courts; they are the judges of legal disputes. We commercialise with proper regard for court decisions. In this case it was positive for Mylan and Brabio, so we were able to launch in January this year.
AN: What were the unmet patient needs and price issues in the MS market that prompted Mylan’s decision to pursue a generic version of Copaxone?
JB: Mylan’s glatiramer acetate is a therapeutic equivalent to Teva’s Copaxone and the main strategy of Mylan is to bring additional access for the patients, to bring more treatment options for the healthcare professionals and, ideally, bring those things in a cost-efficient way so the NHS or the payers also see benefit there.
Multiple sclerosis patients are quite challenging to treat and Copaxone is the only treatment currently accepted in most countries. We were happy to bring Brabio, a therapeutically equivalent product, to the UK market in January with the main hope of bringing more access to patients, more treatment options for the healthcare professionals and better value for money for the NHS.
This is usually the way we work at Mylan, with multiple sclerosis or other diseases – we focus on bringing new products to the market that bring those three key benefits for the three key stakeholders.
The cost of glatiramer acetate is quite high and as you can imagine, in some areas, not all patients were treated as early as they could have been, so we are hoping that by bringing a better value proposition, the savings will be either used to treat more patients or will be used to make other innovative products for MS patients.
The idea is to provide a high-quality option for patients, healthcare professionals and the payers and as a global healthcare company, Mylan have been doing this for more than 55 years.
AN: Do you think an initiative like the NHS’s Medicines Value Programme is worthwhile as a way of aligning medicines to value more clearly, and is it something that will be useful for generic and biosimilar drug developers?
JB: In the UK, we have more than 500 products and we are very used to providing treatment options in countries, such as the UK, where we can create significant savings and access to patients.
The generics have more than a 65% market share in the UK and we like to think that annually we create savings of between £13bn and £14bn to the NHS. Brabio is just one more example of bringing high quality products at low value propositions for the payers.
I think the Medicines Value Programme will in the future help Mylan to bring more generic drugs to the UK, but the UK is already quite positive towards generics. The penetration of generics and the prescribing habits is one of the highest in the Europe and the price of the medication is one of the lowest in Europe.
The next challenge for the NHS is to look at biologics. The reason why the NHS spending has increased over the last decade is because of high-speciality products in hospitals, which are mainly biologics. We are soon to see many so-called biosimilars in the market, which are similar to generics in that they are therapeutical equivalent to a reference product, but they are usually more complex to make and authorise for use, but programmes like Medicines Value will probably stimulate a faster switch from the originator to biosimilar options when they come to the market.
AN: Has Mylan identified other therapeutic areas that could be disrupted by new generic products in the future?
JB: Many biologic products are soon to lose their exclusivity so biosimilars will be welcomed; this will be an area of investment for Mylan.
There a few therapeutic areas in which we are by far leading in the UK either with our brands or our branded generics.
In preparation for the introduction of Brabio, and in the launch phase, which was mostly in Q1 and Q2, we did partner with groups of healthcare professionals and with payers from the NHS.
We want to align these products with more patient educational tools and programmes for when the products are part of the treatment algorithm.
We have moved away from just providing a product and trying to supply a solution. Whether it is patient awareness or whether it is healthcare professional education or NHS awareness that it can save money if it uses more of our products. We have tried to really partner with external stakeholders – the more we do that, the more we understand their needs.
AN: What are the main challenges in terms of working in the UK and with the NHS in the generics market?
JB: It is possible to convince the payers and the prescription guidelines that a new treatment option is better value for money and healthcare professionals should start using them more.
When healthcare professionals are used to prescribing the same brands for decades, it is sometimes difficult for them to understand the importance for their patients and for the payers to evolve and include more treatment options in their prescription habits.
It is one thing to be approved and recommended as a good value option, it is another thing to have the healthcare professionals, in the context of the complexity of the UK healthcare system, to recognise it and implement it.
The savings from generics are very theoretical until they are fully implemented. It is only when a good number of patients are being treated with a better-value product that the savings are really happening for the NHS.
This issue is something that we cannot control, but we try to use our educational campaigns and our awareness programmes to get healthcare professionals to really see the benefit of different treatment options especially when they are better value for money.