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Manufacture Business Practice, Biosimilars, Trends & Forecasts

Biosimilar Backer

You’re passionate about the benefits of biosimilars – why?

There is no country on earth right now where medical systems are not under strain. Yes, biologics have revolutionized medicine by providing treatments for incurable diseases, but these medicines are expensive. However, it is possible to produce the same medicines at lower costs. And once the price point is adjusted, we can reduce the pressure on medical budgets. The money saved can be used for other (newer) life-saving drugs. Some people in the industry are against biosimilars, with some innovators scare mongering so that they can hang on to a monopoly, but we need biosimilars! Like it or not, biosimilars are an effective solution to healthcare costs – and will become universal as more governments start acting.

How did you get involved with the biosimilars industry?

I’ve worked in biotech for over 25 years. Much of my career was spent working for companies that produce biological entities, including Biogen, one of the oldest biotech companies around. I’ve had the good fortune to be involved in taking three biological drugs all the way from the clinic to commercialization, so I know the hard work that is involved. But at some point I began wondering about what comes next.

When I first heard about the concept of biosimilars, I must admit I was a little skeptical. I thought it would be very difficult – perhaps impossible – to copy a biologic considering that most biologics are made in natural systems. How do you engineer a different cell to produce the same biologic with the same post-translational modifications? I was intrigued and did more research – and I took it on as a challenge, because it would bring enormous benefits to patients. India-based Lupin has traditionally focused on generics, but biosimilars are a natural progression. Joining Lupin was a fascinating opportunity given that most of my career had been based in the US. And because India is relatively poor, many biopharmaceuticals are completely out of reach. What a difference it would make to be able to bring these essential medicines to a point where wider numbers of patients can afford them…

And actually, it isn’t just a problem for countries like India. Think of the US; if someone is unlucky enough not to have insurance, then they are “written off.” In a way, India is in a better position because biosimilars have really taken off so there is a lot of competition to bring prices right down.

Some people in industry have made comments about the safety of medicines made in India…

A significant percentage of all the world’s generic medicines are made in India – patients all over the world benefit from medicines that come from India and I don’t think a lot of people know how well these drugs have been made! All the major companies follow cGMP and the regulatory climate here is very effective for generics and biosimilars as regulators don’t discriminate between innovator and copycat drugs – the final decision will be made based on quality. There are many misconceptions about the safety of biosimilars and manufacturing processes, but biosimilars tend to use newer manufacturing technologies than the innovator. I’ve seen head-to-head studies where the biosimilar drug could be better than the innovator drug because of the use of more modern technologies and high-end analytics.

Do you think biosimilars will ever take hold in the US?

Yes – eventually. Because someone somewhere is paying for the current system and that is not sustainable. I think uptake has been slow in the US because many of the innovator companies are based in the US, and they’ve had a huge influence on legislation. The hurdles for launching biosimilars in the US are significant. Even big pharma companies are struggling to launch biosimilars – forget about small companies like us! Things will remain difficult until there is an even playing field. Right now, contracts and rebates are preventing insurers from choosing biosimilars – so they aren’t being used. And this does not incentivize the development of biosimilars, particularly for small companies. It is very expensive to get a biosimilar approved in the US, which means there is little leverage to reduce the cost of a biosimilar compared with an innovator product. Despite all of this, I am optimistic. It will change because things have to change. We have our eyes on the US market at Lupin. We have a pipeline of around 10 biologics and we want to take some of these to the global market. At some point we will crack the US market too.

How do you think the industry needs to change?

I would like to see a change in the way that biosimilar molecules are scrutinized and a simplification of the requirements for demonstrating biosimilarity. Science has improved a great deal – and will continue to improve in the future. We can clearly show whether a biosimilar has the same route or mechanism of action as an innovator drug – no matter how “dissimilar” it may be. And a lowering of regulatory hurdles does not mean we have to compromise safety and efficacy (which should never happen). It would be great to make it easier for biobetters to come to market. Right now a biosimilar must be similar, but it can’t be better. If it’s more potent than the originator then you’ll need to spend more money on additional trials. But most companies cannot afford to do that. What a shame there is not more incentive to develop products that offer improvements for patients!

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About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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