Samba Epis, Synergy Between Direct Sales Network and 'Exchangeability Satisfaction' in the Similar Market?

Humira Biosimilar
Interchangeability Certification Phase 4 Success

Direct Sales Potential Raised Through Biogen Division Acquisition
Profitability Improvement and Rapid Market Response Expected

Samsung Bioepis (hereinafter Bioepis) has laid the groundwork for securing interchangeability, a key weapon to increase market share in the US Humira (active ingredient adalimumab) biosimilar (biopharmaceutical generic) market worth about 25 trillion won. Furthermore, with prospects of establishing an overseas direct sales (direct sales) system through mergers and acquisitions (M&A), expectations are rising that Bioepis's entry into the overseas biosimilar market will become more aggressive.

Samsung Bioepis's Humira biosimilar 'Hadlima'
[Photo by Samsung Bioepis]

Bioepis announced on the 2nd that it achieved the primary endpoint in the Phase 4 clinical trial to secure interchangeability of its Humira biosimilar, 'Hadlima.' From August last year to May this year, the company conducted a Phase 4 interchangeability clinical trial involving 371 patients with moderate to severe plaque psoriasis in Eastern Europe, including Poland, the Czech Republic, and Lithuania. Until week 12, patients were administered the original drug, and from week 13, patients were randomly assigned in a 1:1 ratio, with the maintenance group continuing the original drug and the crossover group alternating between Hadlima and the original drug. As a result, the primary endpoints set by the area under the concentration-time curve (AUC tau) and maximum blood concentration (Cmax) at weeks 23 to 25 met the pre-defined equivalence criteria. Efficacy, safety, and immunogenicity were also similar.

Proving interchangeability is important due to the nature of biopharmaceuticals. Because biopharmaceuticals are based on living organisms, exact replication of the original is impossible, and only similar replication is feasible. This is why biosimilars are separately labeled with active ingredient names such as 'adalimumab-bwwd (Hadlima)' and 'adalimumab-aaty (Yuflyma)'.

Therefore, unlike synthetic drug generics, biosimilars are generally not allowed to be substituted in the US. However, if interchangeability is proven, pharmacists can substitute the drug, enabling an increase in market share. The only biosimilar recognized for interchangeability by the US Food and Drug Administration (FDA), Boehringer Ingelheim's 'Cyltezo,' is currently listed without fail in major Pharmacy Benefit Managers (PBM) formularies despite being a low-concentration product with much lower preference compared to the high-concentration (HCF) adalimumab product. Accordingly, the company expects that Hadlima, developed in both low and high concentrations, can have all concentrations recognized for interchangeability, allowing for more effective market penetration.

Similarly, Celltrion is conducting clinical trials to secure interchangeability for Yuflyma, targeting the end of 2024, and companies like Amgen (Amjevita) and Pfizer (Abrilada) are also developing interchangeability. However, the FDA has recognized only four interchangeable biosimilars so far: Cyltezo, Semglee and Rezvoglar (Lantus biosimilars), and Simlandi (Lucentis biosimilar).

A Bioepis official stated, “We have confirmed that the primary endpoint was met in the clinical trial to verify interchangeability of the Humira biosimilar product and plan to proceed with subsequent procedures for related regulatory approval." However, actual interchangeability approval is expected only after July next year. Since the first biosimilar to be recognized for interchangeability is granted one year of exclusivity, the FDA is likely to withhold approval until that time.

Meanwhile, as cases of establishing overseas direct sales systems increase in the domestic pharmaceutical and bio industries for reasons such as profitability improvement and marketing strategies, there is also speculation that Bioepis may engage in direct sales.

According to related industries, Biogen, which is experiencing management difficulties including executive changes and large-scale restructuring after the commercial failure of the dementia treatment drug 'Aduhelm (aducanumab),' recently put its biosimilar business unit up for sale. This sales-specialized business unit, which does not conduct direct research and development (R&D), has about 300 sales personnel in Europe and the US and recorded sales of $751 million (about 968.7 billion won) last year. Since Bioepis was established in 2012 as a joint venture between Samsung Biologics and Biogen and has continued cooperation with Biogen, it is reportedly a major candidate for acquisition.

The biggest advantage of direct sales is ultimately securing profitability. When going through a partner company, a commission of about 20-30% of sales revenue is usually paid. If direct sales are implemented, commissions disappear, enabling profitability improvement, and the effect of increased profits grows especially as the number of products sold increases. In terms of sales strategy, unlike before when continuous consultation with partners was necessary, it becomes possible to respond more closely and quickly to the market.

Acquiring Biogen's biosimilar business unit could be a clever way for Bioepis to enjoy the benefits of direct sales while eliminating risks. The biggest threat in the early stages of direct sales is building a new sales network. Initial investment costs for establishing a sales network are substantial, and competition to recruit good sales personnel is intense. However, if Bioepis acquires Biogen's business unit, which already has a considerable sales network, it can immediately establish a competitive direct sales network.

Currently, Bioepis sells the Humira biosimilar 'Imraldi' and autoimmune disease treatment biosimilars 'Benepali' and 'Flixabi' in Europe through Biogen, and the ophthalmic disease treatment biosimilar 'Byooviz' in the US and Europe. However, in the US, the Humira biosimilar is sold under the product name Hadlima by another key sales partner, Organon. Since it is still in the early stages of launch, regaining rights through direct sales is expected to take considerable time, so the immediate impact on the US Humira biosimilar competition will be limited.

This content was produced with the assistance of AI translation services.