With $63 billion in global biologics sales going off patent by 2016, opportunities are out there for Big Pharma to gain fresh revenues in an extremely lucrative market.
Genentech/Roche’s blockbuster monoclonal antibody rituximab, for example, loses patent protection in February 2012, and there are already 6 biosimilars hot on its heels, in a race featuring Sandoz, Spectrum and Teva.
Forecasts suggest annual sales of a rituximab biosimilar will reach $500 million in the EU alone.
But what are the market access challenges facing drug companies developing biosimilars, and how can Pharma companies look to overcome them?
These topics were discussed recently at a PM Society event attended by WCG, ‘Understanding the Impact and Critical Elements of Market Access for Biosimilars in Europe’, held at the Royal Society of Medicine in London. The panelists included Dr Rakesh Virma (Senior VP at Prescient Life Sciences), Paul Tredwell (Head of Biopharmaceuticals at Sandoz UK) and Dr Anthony Grosso (Principal Pharmacist at University College London Hospitals).
The panelists gave their perspectives on the impact regulatory changes will have / are having on the biosimilars market, and offered interesting insights into the future for biosimilars.
The EU is still the leading light for biosimilars – 14 biosimilars have already been approved here and, interestingly, uptake seems to be regional, with Yorkshire in the UK ranking highest for biosimilar use.
In the US, guidelines are still being developed; the FDA this year requested $124 million of the 2012 budget to develop a ‘biosimilars pathway’. This could, however, prove to be a pathway to nowhere, with payers arguing that more data are needed to prescribe than the FDA had planned to request.
One thing the panelists all agreed onwas that once regulations do finally settle in the US, (predicted at the end of 2011, although the latest reports suggest that the top-line details could come out any day now) this will have a huge impact on the EU space, adding pricing pressures as global companies enter the market.
Globally, before a biosimilar can be presented for approval, it must demonstrate equal safety and similar efficacy in clinical trials; however, despite this, we are still seeing resistance, particularly from clinicians.
According to Dr Grosso there are four key drivers for this resistance: Clinicians feel there is a lack of information around biosimilars data, misinformation on how a biosimilar is developed, and a key concern over how using biosimilars might affect their relationships with originator drug companies.
So how can Pharma ensure clinicians are buying into biosimilars?
Paul Tredwell of Sandoz UK has worked in originator and generic/biosimilar markets, and said “Clinical trials must be more transparent. Sandoz invests heavily in clinical trials and clinical access, and biosimilars require much more investment than generics (but less than originators.) We spend $75-$250million on development over 7-8 years before bringing a biosimilar to market.”
Paul also recalled Sandoz meeting with the NHS “hundreds of times” to educate staff on biosimilars, and how they are developed.
The panel agreed that the market for biosimilars is complex, and there are different concerns in each disease area.
While clinicians and patient groups are focused on safety and efficacy, payers are also looking for health economic data, tenders and dose equivalence, and market price.
With this in mind, Paul suggested Pharma companies need to take a more branded approach to marketing biosimilars in order to access complex products and disease areas, explaining that each brand must behave differently in each market
What about cost? Are we going to see prices slashed versus originator drugs, due to less investment for companies, reduced time to market, and fewer patients needed in clinical trials?
The improved affordability of healthcare that could result from the use of biosimilar medicines is very real.
As an example, the EPO biosimilar introduction in Germany resulted in €60m annual savings in the first year, and it is predicted that biosimilars in Germany alone could contribute to €1 billion annual savings from 2017.
Tredwell claimed that although cost is not the driving factor in manufacturing biosimilars for Sandoz (patient access is…), they are committed to marketing biosimilars at a 20-25% discount versus originator products.
As 2013, and the first approved monoclonal antibody biosimilar approach, along with an imminent announcement from the FDA, we are set to see the future for biosimilars more clearly – watch this space!