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European Biopharmaceutical Review

In the Lead

Ten years ago, I attended an analyst briefing by the Head of Research at a large multinational pharmaceutical company, where he spoke effusively about biosimilars – as well as his firm’s strategy to achieve five approvals within the decade. He went on to explain that the industry was shifting towards a greater proportion of biologics among the top ten drugs, due to their higher profitability and greater regulatory and scientific barriers to entry. With certain popular and highly lucrative biologics coming off-patent, biosimilars could support a price on par with the innovator, rather than the deep discounting experienced by small-molecule generic drugs. It appeared to be the perfect strategy for a low-risk blockbuster.

When it comes to biologics, the common wisdom is that the process is the product; biosimilar approval relies on some degree of clinical approval, perhaps as extensive as that required for the original innovator. A conventional generic drug, on the other hand, needs only to prove identity and bioequivalence – a much lower bar.

Concerns and Rewards

The issues for biosimilars are many, but so too are the rewards – estimated to value tens of billions of dollars in cost savings to over-strained global healthcare systems, greater market access due to anticipated discounted pricing, and a low development risk path to a blockbuster. However, for regulators, there is the conundrum of an approval process for drugs that are similar – but not identical – and possibly not interchangeable.

Moreover, this is a political minefield, as legislation tries to balance the needs of innovators, imitators and the public interest. Unsurprisingly, the early regulatory guidance and first decade of approvals have come from jurisdictions within national health systems. Indeed, in the US, biosimilars could only gain political traction in the context of the 2010 healthcare reform, where they were seen as an important contributor to ‘balancing the books’ on looming medical expenditure.

For the moment, an abbreviated approval pathway appears to be relatively settled, and versions are comparable in both the US and EU. Biosimilars must demonstrate:
  • Reliance on safety and efficacy of the reference product
  • Full preclinical and clinical data – noted case by case
  • Same mechanism of action
  • Same route of administration
  • Same dosage form
  • Manufacture in an approved facility
Questions of interchangeability and direct substitution are still waiting for definitive guidance and precedent. As biosimilars move upscale to more complex entities – like monoclonal antibodies (mAbs) – there is real concern that they may exhibit significant clinical differences in segments of the patient population. For now, post-market surveillance is essential.

The Name Game

This highlights the problem of nonproprietary names. On the one hand, prescribing doctors and patients rely on the non-proprietary name. Yet some differentiation is desirable for accurate medical records, manufacturer accountability, appropriate use and post-market surveillance. As an interim measure, early biosimilars use the non-proprietary name with an appended manufacturer code – and further regulatory guidance is promised.

Biopharma competitors, having entered the field in Europe and Asia, are now looking ahead to the single largest market: the US. At the start of this year, almost 30 biosimilar investigational new drugs had been filed with the FDA. In recent months, the first true biosimilar was also approved in the US – after five years of intense discussion, political debate and a good track record for the product in many other markets. However, with approvals of biosimilar mAbs, the EU still retains the lead.

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Emile Bellott is a member of the EBR Industry Advisory Board and an industry consultant with over 25 years of experience in drug discovery, development and pharmaceutical outsourcing.


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