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Biosimilars and Generics: A no-brainer for treatment?

Published on 28/11/16 at 04:53pm

The industry is poised on the potential widespread adoption of many revolutionary technologies; foremost among them are biosimilars and generics, alternatives to traditional treatment which promise to keep costs low and healthy patients high. Matt Fellows investigates the industry’s complicated relationship with these technologies as it stands today.

In the world of drug development and manufacture, there is what can sometimes seem like an innumerable amount of issues and obstacles which can form a blockade on a treatment’s path to market, and more importantly the patient, not least of which is cost.

Drug pricing is in many ways the engine which keeps the dynamo of the pharma industry spinning; while it primarily manifests as the major factor that determines the accessibility patients have to the treatments they need, pricing is also of course arguably the raison d'être of today’s pharma giants, often to the point of fault and the source of much controversy. Unfettered by strict regulation in the US and chained tightly by the constraints of financially-starved national health systems, patients are often left with no alternative than to submit to often prohibitive pricing as it has increasingly become the norm.

But that norm is now under threat as medical technology brings a new option ever closer; biosimilars and generics represent a new form of medicine that looks to shake up the status quo of the drug market and patient treatment as it is today.

While the two technologies are often mentioned in the same breath and share credit for the revolutionary impact they could have on the industry, they are separated by key elements which divide them as decidedly distinct entities with their own places in the pharma industry puzzle.

Biologic treatment molecules can be anywhere up to 1,000 times bigger than small molecule generic drugs, and are much more structurally complex. Where generics are manufactured purely through chemical synthesis, biologics and biosimilars are developed in living cells and then extracted and purified; these key differences are paramount to the distinction between the two technologies.

According to Amgen, these post-translational modifications, as they are known, can be compared to the impact of farming environment on growing produce:

“The look and taste of the same type of tomatoes will vary in different farm environments because of the quality of the soil, use of fertilisers, type of irrigation and weather elements like rain, air, sunlight. Similarly, differences in biological systems (e.g., type of living cell with slightly different cellular environments) used to manufacture biosimilars may cause different types and levels of modifications, which in turn may affect the quality, safety or effectiveness of the product.

“So, whereas a generic can be identical to a small molecule reference product, biosimilars cannot and are not required to be exactly like the biologic reference product.”

In the same way that they subtly differ in nature, so too do the technologies differ in their specific applications. But, when it comes to creating a more accessible, dynamic pharmaceutical market, they are two sides of the same coin.

Approval breeds adoption

As with any new technology in other fields, its impact relies on its adoption, and its adoption begins with professional approval and a positive consensus. Andrew Roberts, director of market access and external affairs at Napp Pharmaceuticals, spoke to Pharmafocus on where the industry currently stands with its relationship towards biosimilars and generics; with pharma and healthcare professionals warming to the technologies, things are looking increasingly positive.

“We’re at the stage now where different stakeholders, be they clinicians, healthcare professionals, payers or academic policy makers, are all now starting to see the value of biosimilars,” he tells us.

Awareness and education is a major issue in clarifying this value to potential users in order to increase adoption of these new technologies, and conveying this smoothly has unfortunately not been a simple task.

Roberts is a member of the British Biosimilars Association (BBA), a subgroup of the British Generic Manufacturers Association (BGMA) concerned with tackling the issues faced when bringing biosimilars to market. The association has worked not only to educate clinicians on the benefits of biosimilars, but also to dispel certain untruths about their application.

Because of the nature of a biosimilar or generic’s relationship to its originator product, some of the big pharma players are not too happy about their increasing usage; as holders of the rights to the original products from which the alternative treatments are extrapolated, these companies have a strongly vested interest to minimise any potential chance of them cutting into the market share of their products. This has reportedly led to a battle within the industry over the true level of efficacy and value of these new technologies, as patent holders attempt to discredit their use and limit their market impact.

“We know how originator companies have portrayed biosimilars, and there are commercial factors as to how they presented what biosimilars are; our role has been to clarify that information,” Roberts explains.

This increased awareness and valuation of the technology which the BBA has fought for and which we are now seeing is inextricably linked to the lifeblood of pharma: drug pricing.

“Because biosimilars are fundamentally much cheaper than the originator product and because they drive competition in that specific biological sector, the drug acquisition cost is falling, and it falls very quickly,” Roberts says. “There has been a number of biosimilar launches in the UK, but in the last two years there has been two quite big launches: there has been infliximab and etanercept, and etancercept is charting a similar course; it’s showing very similar rates of adoption and similar impact in the market it’s in. So one of the conclusions you can draw is that a more cost-effective biologic means you can treat more patients.”

As education becomes more widespread, this fiscal implication of biosimilars on the industry and its staff becomes more known, and this too has had a strong effect on adoption; while economic pressures are of course very real and a major concern of pharma firms, clinicians are now seeing the benefits for themselves:

“We are seeing, in the UK, far more willingness for clinicians to use biosimilars,” Roberts clarifies.  “Not because they’re under intense pressure from economic aspects, but because they’re starting to feel they could treat more patients with this medicine because it’s cheaper than the originator.

“What we’re definitely starting to see in the fields of rheumatology and gastroenterology are clinicians questioning: ‘Surely now I should be able to treat more patients with infliximab because it’s available much more cheaply than it was a year ago.’ And those questions are growing,” he continues, “and the patient-interest groups who look after the rights and interests of patients with certain long-term conditions are asking the same questions as well. So you’re starting to see a bit of a watershed now where the expectation is that certain measures are put in place to make that clearer to commissioners.”

And these products have a much greater effect beyond simply providing a cheaper alternative to patients, as Roberts is keen to point out:

“It would be inappropriate of me not to flag that competition from biosimilars is bringing down the price of the originator medicine as well.”

Because of this new, cheaper alternative afforded to patients where they were once restricted to high-cost treatments, pharma firms are under pressure to lower their prices to remain competitive, which arguably creates a better climate for all involved.

This in turn has an effect on regulatory decisions concerning the availability of treatments on nationalised health services; with budgets being wrung dry, news of key medicines being knocked back for routine use by regulatory bodies on the ground that their cost cannot be justified is seemingly ubiquitous. With the competition that greater adoption of biosimilars and generics would generate, the new state of the market could spell many benefits for patient access to treatments.

Roberts adds: “In cases where the NHS is still having to buy the originator medicine because patients can’t be switched or there is a need to maintain patients on the originator product, they are paying less for it, and they’re paying less for it because of the biosimilars.”

However, this could prove to be problematic because it illuminates the shortfalls of the system as it is now, which could harm industry relations with patients and prove to deter them from pursuing this new climate.

Roberts notes: “It’s a difficult one, because it’s almost admitting the medicines were rationed before because of their high cost, but I think the sooner we get over that and accept that they were restricted by their high cost or because they were unproven, now that we’ve got biosimilars that are much cheaper, it makes more sense to try and treat more patients.

“If certain biologic medicines were withheld from patients due to affordability, there is now no logical reason why that should continue; you should be able to expand access.”

But are they as effective?

While their status as a cheaper alternative to traditional treatments with all the benefits that comes with it seems to be a compelling argument for the wider use of biosimilars in pharma markets, what good are they if they don’t do the job? The other key piece of the puzzle is efficacy. So, are they as effective as their original counterparts? According to Roberts, the simple answer is yes.

“There’s no evidence so far to show any major differences,” he explains. “The patients are continuing to do well on the biosimilar based on what is being fed back by clinicians, because obviously if there was an issue, clinicians would report that very quickly; there’s very strong pharmacovigilance measures in place so that if anyone had an adverse event then they would have their treatment halted and we would be notified of that and so would the MHRA (Medicines and Healthcare products Regulatory Agency).

“I think you’re starting to see confidence among clinicians who are using biosimilars more widely than they were a few years ago, that they’re starting to understand that in the majority of cases, they see no difference.”

So from an efficacy point of view there is very little reason for a patient not to be treated with a biosimilar alternative as opposed to the originator product if such treatment is available; this point is reinforced even further by the emergence of data from the currently ongoing NOR-SWITCH study. Initiated in 2014, the purpose of the study is to investigate the safety and efficacy of switching treatment from Remicade (infliximab) to its corresponding biosimilar Remsima in patients suffering from rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis. The study’s findings has vast implications for the efficacy, flexibility and application of biosimilars, as Roberts notes:

“I think there is a greater consensus than there was a year ago on some of these topics. And one of the factors for that is, very recently, the NOR-SWITCH data was published which speaks for itself; one of the conclusions you can take from the data is that you can switch patients from an originator product to a biosimilar and it has little or no impact on the patient.”

“That was a powerful source of data,” he continues, “and there needs to be more studies published like that which show you can switch from an originator to a biosimilar, and there also needs to be studies to show that you can switch across biosimilars.”

But despite this huge leap forward, Roberts admits there is still a lot of ground to be covered:

“I think we are a way off from seeing those sorts of studies, and once we have those sorts of studies then everybody in the community will feel more confident about the role of the biosimilar. We accept that there is no scientific data available to prove comparability across biosimilars; we need to see more of that data before we can categorically say you could move to interchangeability. We’re working within what data is available currently, but I’m sure that will change over time.”

Embrace or resist?

Generics share the charge that could potentially shift the pharma climate, but their adoption is again troubled by the same resistance from the major industry players; while branded drugs are protected with market exclusivity until their patent has expired, there is much contention once this period nears. Again, pharma firms do not wish to give up their slice of the pie, and have even been accused of executing ‘pay-to-delay’ strategies, whereby they funnel large quantities of money into the smaller firms developing generic versions of their patented drug in a bid to coerce them into delaying market access. It is ethically a very questionable position and one that has caught the eye of law firms and media headlines over the years. Roberts lays down his opinion quite simply:

“My own view, which I think is the position of the BBA, is that once you see patent expiry, then there is an opportunity for a generic medicine, and generic medicine should bring down the cost of a particular treatment, and with that comes greater access. In an environment where value is being questioned, I don’t believe it’s viable that the industry should continue to look for funding of medicines unless the most is being made of generics.”

According to a report by IMS Health, generic drugs account for 88% of all prescriptions filled in the US today, and may account for 91%-92% of prescription volumes by 2020.

With the branded drug market being estimated by some sources to be worth up to $200 billion, generics are poised to sink their teeth into a huge potential corner of the market; IMS Health further reports that generics are to account for 52% % of global pharmaceutical spending growth in the period 2013 – 2018, compared to 35% for branded drugs. Overall, generic drugs sales are predicted to increase from $267 billion in 2013 to $442 billion in 2017 – an annualised growth rate of 10.6%.

Rates of sales growth for generic medicines are expected outpace those of branded treatments in the coming years, and this should be something to be embraced, not resisted. But the issue of patent ownership is a sizeable bump in the road.

“I think all patent-holders will vigorously defend patent, as they should, because it’s our intellectual property,” Roberts explains. “I think once it’s very clear that a patent has expired, even if it has been subject to a review, it’s expired, and then how you manage that medicine is entirely up to you as an originator company. But once the patent has gone, it’s up to the health system to make the most of how they use that medicine.

 “Once a patent expires, there should be no shortage of manufacturers wanting to come forward.”

A no-brainer

With all the benefits that biosimilars and generics present, their widespread use would seem like a no-brainer, with lower costs with foreseeably the same rates of safety and efficacy, and Roberts agrees:

“The regulatory data that we have that allows a biosimilar to be licensed for the same indications as the originator comes from studies that show that the biosimilar will have a similar clinical effect to the original originator medicine, so based on that, yes, why wouldn’t you use it in every opportunity?”

But the path forward will still be wrought with obstacles as patent-holders fight against any increases in adoption and until doubts over their efficacy are silenced with greater, more robust data. The technologies certain need time to be accepted and to prove their efficacy, but the outlook is certainly looking very positive, if marred by certain commercial politics.

“Whichever way you look at it, it’s never perfect, but generics create competition and competition brings down price, and cheaper medicines will always be positive,” Roberts puts simply. “Generics create headroom, biosimilars create headroom, and that headroom will allow for health budgets to fund new medicines and new technologies.”

There is still much more to be done, and education which illuminates the benefits of biosimilar and generic adoption should be a rallying call to those in the industry to do more to push for their application.

“Slower uptake of generics and biosimilars is driving missed opportunity; any hesitancy in driving uptake of more cost-effective medicines is a missed opportunity,” Roberts concludes. “We have to create headroom within health budgets, because with the situation we have in the UK with an ageing population etcetera, we can’t drive health funding exponentially, it’s a tax-funded system, and manufacturers have to respond to that.”

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