Seven-year switch? Formycon bets on third wave biosimilars with Stelara candidate

By Dan Stanton

- Last updated on GMT

Image: iStock/ckybes
Image: iStock/ckybes

Related tags Monoclonal antibodies

Formycon says it is aiming to bring the first biosimilar of J&J’s immunology best-seller Stelara (ustekinumab) to market as early as 2023 in the US.

As the US market opens up and billion-dollar biologics come off patent, so-called second wave biosimilars have grabbed a lot of attention. A number of companies are already competing against J&J’s Remicade (infliximab), for example, and there are over 30 companies​ developing versions of AbbVie’s $16bn (€14.7bn) a year​ Humira (adalimumab).

But less attention has been made of third wave biosimilars: versions of more complex mAbs or antibody fragment drugs coming off patent after 2020.

Germany’s Formycon, however, has chosen to focus in this third wave space and announced yesterday it is targeting Stelara (ustekinumab) – an immunology biologic which clocked in revenues of $3.2bn for J&J last year and still has a remaining patent life of up to seven years.

Riding the waves...

First wave products are generally versions of cytokines, growth factors and hormones already off patent - such as filgrastim and epoetin alfa.

Second wave biosimilars are generally monoclonal antibodies which come off patent before 2020, for example Pfizer/Celltrion’s recently US approved infliximab.

Third wave biosimilars are biologics coming off patent after 2020 which are generally more complex mAbs or antibody fragments

“Our general aim is to be first on the market with a biosimilar after the relevant legal protection of the reference product expired,”​ Formycon spokesman Thorsten Schüller told Biopharma-Reporter. “We expect that it should be possible to launch a biosimilar for Stelara in the US in 2023 and in Europe in 2024.”

He added while some other companies have said they might aim to develop a biosimilar for Stelara, the “attention within the biosimilars industry still lies on the second wave,”​ biosimilars.

But “given an approximate development time of 7-8 years, we think it is the right time for developing ‘third wave’ assets – especially if you aim for a day one launch of the biosimilar, as we do.”

Along with the Stelara candidate FYB202, the Munich-headquartered firm is also developing versions of Roche/Genentech’s Lucentis (ranibizumab), Regeneron’s Eylea (aflibercept), and a fourth undisclosed third wave biosimilar.

“We generally see great business opportunities in the third wave. As an example and with regard to our Lucentis biosimilar, we believe that we are in an extraordinary positive competitive position,”​ said Schüller.

Last August​, Formycon’s share price jumped 16% after Pfizer abandoned its Lucentis biosimilar programme, handing the rights for the molecule back to partner Pfenex.

Formycon’s financials

Formycon announced its end of fiscal year 2016 financials earlier this month, reporting a 15% year-on-year increase in revenues to €19.5m ($21.2m), though saw a net loss of €4m.

Our financial situation is very solid. Due to our two out-licensed biosimilars we generate a steady flow of revenues from our partners for the development of these products,” ​Schüller told us.

“Furthermore we have a cash position of around €17 million, which is, in consideration of our current strategic approach, quite comfortable. The loss in 2016 was planned as we invested significantly in the development of the products which are not out-licensed yet and therefore into the future of the company.”

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