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Approval of the first biosimilar antibody in Europe: Why the world will be watching

19 September 2013 Margaret Labban

On 10 September 2013, US-headquartered biopharmaceutical firm Hospira and South-Korean partner Celltrion became the first companies to gain marketing approval of monoclonal antibodies (mAb) through the biosimilar pathway in the European Union. Prior to this, the EU had approved biosimilars for human growth hormones (hGH), erythropoietins (EPO), and granulocyte colony-stimulating factors (GCSF), however mAbs are much larger and more complex than stimulatory glycoproteins and hormones, and include some of the highest-selling drugs currently on the market. This biosimilar mAb approval was also the first in any highly-regulated market worldwide.

The approval is considered a key milestone for biosimilars – however questions remain regarding uptake and the extent of biosimilar substitutability and interchangeability that will be critical for the sector’s success.

Inflectra and Resmima: The first biosimilar mAbs in Europe

The European Commission approved Inflectra and Resmima, two brand names for the same biosimilar version of J&J and Merck’s Remicade (infliximab), a chimeric antibody against TNF alpha, indicated for a range of auto-immune disorders including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and psoriasis. Remicade generated approximately USD2 billion from European market sales in 2012. Based on EU biosimilar provisions, Inflectra and Resmima are considered alternative treatments to Remicade. But the European Commission does not have the authority to determine substitutability or interchangeability – key aspects to biosimilar uptake that are decided at the national level.

Why are biosimilars not automatically interchangeable?

Unlike generics, biosimilars are not identical to the reference biologic product. They are, as the name implies, very “similar”. Biologic drugs are complex molecules, nearly 100 to 1000 times larger than small molecule drugs, made of or isolated from living cells, and are almost impossible to copy without having access to the exact biotechnological tools and living material utilised by the originator. For mAb biosimilars, having the exact same amino acid sequence as the branded biologic is not enough, as there are subtle differences such as glycosylation variations that could come about during production that potentially have a significant impact on the antibody’s structure and consequently activity and stability. Therefore, biosimilars are subject to extensive pharmacokinetic, immunogenicity, and clinical assessments to ensure the candidate is as similar as possible to the original product. However, there is always a risk of uncertainty regarding interchangeability - different sub-populations might carry a sensitivity towards the biosimilar that may have not been identified in clinical testing, alternatively certain individuals might develop an immune reaction to the slightly altered version if switched mid-treatment. In fact, for more complex biosimilars, switching may not be recommended at all, and prescription level substitution may be allowed only for new patients. For all biosimilars, post-marketing studies are crucial in verifying long-term safety and efficacy of the drug.

Why take the risk with biosimilars?

The answer is simple: significant savings. Biologic medicines are some of the most expensive drugs on the market, and have cost the healthcare system billions. It is estimated that mAb biosimilars may result in over EUR20 billion in savings by 2020, particularly in key markets such as France, Germany, and the UK. Concerns over the interchangeability of biosimilars may be warranted to some degree, however it is likely that uptake will grow significantly once safety and efficacy is confirmed in the population and once there are enough biosimilar products available so that treatment-naïve patients can be started directly on the biosimilar. As physicians grow more confident in prescribing biosimilars, and patients feel comfortable using them, and payors actively push for their utilisation, their growth potential will likely be realised.

For now however, the world is watching

The first complex chimeric antibody biosimilars are to be commercialised in an advanced market (although market entry will likely be delayed in some major European countries until February 2015 due to paediatric patent exclusivity extension for the originator) and will likely pave the way for countless others in the future. Not just in Europe, but in Canada, Australia, and maybe even the US, if and when the FDA approves its first biosimilar through an official abbreviated biologics pathway. Several states have already began approving bills that would either limit or allow biosimilar substitution in pharmacies. How Inflectra and Resmima will perform in the EU will likely shape decisions such as this in the future that will have a far-reaching impact on the biosimilar sector moving forward.

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