April 26, 2024

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[THE INVESTOR] South Korean biopharmaceutical firm Celltrion said Jan. 18 that it’s too early to talk about the development of subcutaneous version of Truxima, a biosimilar of Roche’s Rituxan, which seems to be an inevitable step to compete with the originator drug to tap deeper into the European markets.

“As Truxima is still awaiting approval from European Medicines Agency, we are not at the stage where we can unveil a development plan for its SC version yet,” an official at Celltrion told The Investor. 

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Celltrion has been seeking to storm the European markets with Truxima, a biosimilar of Roche’s blockbuster lymphatic cancer treatment Rituxan, also known as Rituximab, which is highly expected to receive approval from the EMA in the first quarter of this year.

Analysts and investors are closely watching whether the Korean company will develop a convenient-to-use SC formulation of Truxima soon to quickly increase its market share in Europe which has been dominated by global pharma giants like Roche.

Unlike the existing version of Truxima that requires intravenous injection, the SC version will enable patients to administrate the drug under the skin by themselves which reduces delivery time dramatically without the hassle of visiting hospitals.

To defend against cheaper biosimilars, Roche received EU approval for new SC formulation of Rituxan for people with chronic lymphocytic leukemia in June last year.

Pharmaceutical firms facing patent expiration often look to extend the lives of blockbusters by developing new formulations.

Rituxan will lose its US exclusivity in 2018 while the biologic expired in Europe in 2013.

Currently, Celltrion is developing a SC formulation of its rheumatoid arthritis treatment drug Remsima, a copycat of Remicade, in order to strengthen its footing in the global tumor necrosis factor alpha inhibitor market.

By Park Han-na (hnpark@heraldcorp.com)