Samsung Bioepis riding the biosimilar third wave

Samsung Bioepis has beefed up its biosimilar pipeline with versions of Lucentis (ranbizumab) and Soliris (eculizumab) under development.

In Europe, South Korean biopharma firm has achieved commercial success with four biosimilar products. In the US – through commercialization partner Merck & Co. – it has launched one and has two other biosimilars under review.

When looking at the market and large pharma biosimilar makers such as Pfizer and Sandoz “we are up to par with the ‘big boys’ in terms of biosimilar developers,” Brian Hosung Min, senior vice president of the Drug Substance Team at Samsung Bioepis, told BioProcess Insider. “In fact Samsung Bioepis has a richer pipeline than the others,” he added.

2020 vision? Third wave biosimilars are mainly complex MAbs and fragments which lose exclusivity from 2020 onwards. Image: iStock/olm26250

That pipeline includes versions of some of the top selling biologics such as Amgen’s Enbrel (etanercept), AbbVie’s Humira (adalimumab), J&J’s Remicade (infliximab), and Roche’s Herceptin (trastuzumab).

But the firm is looking beyond the current wave of biosimilars, and Min revealed a version of Lucentis (ranbizumab) – SB11 – is currently in Phase III trials.

Third wave biosimilars

First wave biosimilar products are generally versions of cytokines, growth factors and hormones already off patent, for example filgrastim and epoetin alfa.

Second wave biosimilars are mainly monoclonal antibodies (MAbs) that come off patent before 2020. Numerous companies have developed – or are developing – versions of blockbusters such as Remicade and Humira.

The third wave refers to the generally more complex MAbs or antibody fragments that lose exclusivity over the next few years.

Lucentis, a monoclonal antibody fragment approved to treat the ‘wet’ type of age-related macular degeneration, is one of these third wave products, coming off patent across various markets from 2020 onward. The drug pulled in around $1.4 billion for Roche in 2017 and $1.9 billion for Novartis, which owns the rights outside of the US.

Samsung Bioepis is one of a handful of firms which have announced ranbizumab programs. Other include Formycon, Pfenex, Xbrane and Dyadic.

Alexion’s Soliris

And though Min did not divulge details, according to clinicaltrials.gov, Samsung Bioepis has a proposed biosimilar of Alexion Pharmaceuticals’ Soliris (eculizumab) in early-stage clinical trials.

The MAb, used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, pulled in global sales of $3.1 billion for Alexion in 2017.

Other Soliris biosimilars include Amgen, though both Amgen and Samsung Bioepis may have to wait until 2027 to launch their programs after Alexion was last year awarded patent extensions.