2016 marks the tenth anniversary of the launch of the first biosimilar in Europe and Medicines for Europe claims:
As of October 2016, the European Medicines Agency (EMA) has approved 23 biosimilars and the United States (US) Food and Drug Administration (FDA) – which took longer to formulate its guidance for biosimilar development – has just approved its fourth. Many other highly regulated markets – such as Canada, Australia, Japan, and South Korea – are demonstrating a similar commitment to introducing biosimilars, recognizing the significant benefits of making important biologic therapies more affordable and thereby increasing patient access within their populations.
Only a few years ago, when biosimilars were still relatively unfamiliar, many prescribers and other stakeholders were concerned about whether these products would prove to be as effective and safe as originator biologics and, in particular, about the possibility of greater immunogenicity. Even those who were more convinced – especially in the light of the rigorous regulatory requirements – were doubtful about the idea of switching between an originator and a biosimilar in individual patients. Most announcements from academic societies advocated caution.
Today the picture is very different. Confidence among clinicians – and the societies who represent them – has increased significantly. This growing confidence is underpinned by accumulating clinical experience with licensed biosimilars worldwide, and a growing number of publications confirming the clinical similarity of approved biosimilars with their originators. Reassuring data from switching studies has also been forthcoming and most importantly – there have been no negative reports regarding biosimilar usage.
FDA approves four biosimilars
The US FDA – which has so far been seen as the most cautious and conservative regulatory body – has now approved four biosimilars (filgrastim, infliximab, etanercept, and adalimumab) and has in most cases also approved extrapolation of the data submitted to all other licensed indications of the relevant originator. The agency has also increased its internal resources to handle the volume of biosimilar applications it is now receiving.
Academic medical societies endorse biosimilar use
More national bodies dedicated to biosimilars
Many countries have now re-branded their national generics associations to include biosimilars or have set up dedicated biosimilars committees and panels. 2016 saw the launch of the British Biosimilars Association and a similar organization in Japan.
More biopharma companies plan to develop biosimilars
Payers drop coverage of originator biologics in favor of biosimilars
Innovator manufacturers are utilizing defensive tactics
Faced with biosimilar competition, the manufacturers of top-selling originators are finding new ways to enhance the competitiveness of their products beyond price cutting:
Patent lawsuits delay the launch of biosimilars
The first FDA-approved biosimilar, ZarxioTM, was licensed in March 2015 but did not reach the market until September of that year due to litigation by the originator manufacturer, who claimed its patents had been infringed. Similar lawsuits are highly likely to delay the launch of the other FDA-approved biosimilars, despite the “friendly” exchange of patent information that is supposed to happen before FDA submission. Some originator products have numerous patents related not only to the active substance but also to the formulation, method of manufacture, and means of delivery, meaning that lawsuits can be complex and lengthy to resolve.
Interchangeability is yet to be fully resolved in the US
For a patient already stabilized on an originator biologic, the acceptability of biosimilar substitution by a pharmacist (without necessarily consulting the prescriber) is naturally seen as an advantage by biosimilar manufacturers. The US FDA intends to grant a designation of interchangeability as an additional approval step, distinct from approving a product as a biosimilar. Only interchangeable biosimilars will be eligible for pharmacist substitution – and even then, individual States have the power to prevent or sanction this. However, the FDA has yet to confirm the criteria for gaining interchangeability approval.
Some governments discourage biosimilars through price controls
In Spain and in the Republic of Ireland, originator manufacturers are obliged to automatically discount their prices upon patent expiration. This mandate reduces the financial incentive to introduce biosimilars into these markets.
Understanding and education still patchy among prescribers
In 2016, SERMO, the leading global social media network exclusively for doctors, announced the results of a biosimilars poll involving 3,849 clinicians from 28 countries worldwide. Encouragingly, it showed that 90% of those polled were receptive to prescribing biosimilars. However, of these, nearly half said they would need more educational information on biosimilars before prescribing them.7
Patient awareness of biosimilars is still low
An international survey conducted to understand the levels of awareness of biosimilars among patients, caregivers, and the general population in the US and EU (n=3,198) has shown that – even among patients with relevant diagnosed conditions who have participated in patient support groups – awareness of biosimilars stands at only 20–30%. Among the general population (18–64 years of age), awareness is only 6%.8Clearly, the barriers to optimal biosimilar uptake remain fairly formidable. However, as positive clinical experience with biosimilars accumulates globally, and the advantages of reduced expenditure and greater patient access become more evident, the gathering momentum behind the biosimilars revolution seems unlikely to abate.