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More of the same: The importance of strategic communications planning for biosimilar entry

GCI Health's Hannah Morris considers the importance of strategic communications planning for biosimilar entry, a market anticipated to deliver between €8-26bn in savings across the European Union by 2020.
According to a study recently published by Thomson Reuters BioWorld, hundreds of companies are now involved in the production and supply of biosimilars, indicating that the future for this emerging market is bright. Indeed biosimilars, or ‘follow-on’ biologics, are expected to deliver between €8-26bn in savings across the European Union (EU) by 2020.

Although figures of this magnitude are likely to attract the attention of European governments facing rising healthcare costs, it is important that the scepticism and comparability concerns that still surround these products are adequately addressed early in their development, so that their approval and uptake is not hindered significantly. It is important to remember that as well as bringing cost savings, biosimilars could also bring lifesaving treatments to some patients previously unable to access them at all. Therefore companies planning to bring biosimilars to market should ensure that a strategic pan-European communications plan, taking into consideration all key stakeholders, is part of their pre-launch and launch marketing plans.

What is becoming increasingly clear to companies involved in the emerging biosimilar category, is that strategic communications planning is even more crucial when launching a biosimilar than it is when bringing a new branded medicine to market as, alongside all the usual access hurdles, biosimilar manufacturers will also come up against originator companies ramping up their communications around the guaranteed efficacy and safety of their products and the
complex manufacturing processes required to produce them. This may well raise doubts around the comparability of biosimilar medicines which will need to be acknowledged and addressed.

Communications planning
Extensive landscape assessment, stakeholder mapping and advocacy development should feature in any pre-launch communications plan, as gaining ‘buy-in’ from influential physicians, professional associations, patients and advocacy groups, around the equivalent efficacy and safety profile of a biosimilar as well as its value, will be critical - particularly when it comes to conversations with payers further down the line. Physician anxiety around prescribing biosimilars is likely to continue when biologics exist which are proven to be safe and effective. This may be more pronounced in some areas such as oncology where treatment decisions are less cost sensitive and efficacy data paramount.

Moving on to the launch phase, preparing for approval and reimbursement milestones will require comprehensive scenario planning at a pan-European level, particularly as national guidelines around product interchangeability differ so significantly. Working closely with local affiliate communicators will be fundamental as the company navigates through these hurdles, often for the first time. Despite the barriers, however, the fact that 20 biosimilar products are currently approved for use in the EU (including complex monoclonal antibodies) bodes well for the future market here. Although the FDA is yet to approve a biosimilar for use in the US, it is worth watching what happens with the expected first wave of approvals in 2015, as it may well have communications implications on this side of the pond.

Pricing considerations
As the price of biosimilars is often higher than expected - around 20% less than the reference biopharmaceutical which is much lower than the 50% discount seen with some generics - spokespeople should be well prepared to discuss value as well as the high development, manufacturing and storage costs associated with biosimilars. By their very nature, the fact that these drugs can only ever be copies of the originals will also mean safety issues must be taken seriously with appropriate monitoring processes initiated and spokespeople prepared. Continuing to communicate data from post marketing safety studies will be key to continuing to reassure all stakeholders.

At a time when governments need to find cost savings in healthcare (only last month it was announced that the UK’s NHS is facing a potential budget shortfall of €38bn by the end of the decade), and large numbers of blockbuster biologic drugs are about to go off-patent, it would seem that the growth of the biosimilar market is somewhat inevitable. With appropriate safety and efficacy measures and a robust strategic communications plan in place, companies with varying levels of product launch experience should be able to successfully deliver a biosimilar into the European marketplace.

20th November 2014

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