Celltrion Reveals Data As It Rolls Out Higher-Strength Adalimumab
Presents One-Year Data From Phase III Trial For Yuflyma Rival To Humira
As it begins to roll out its Yuflyma higher-strength adalimumab biosimilar in Europe, Celltrion has reported positive one-year data from a Phase III trial for the 100mg/ml Humira rival.
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Celltrion will adopt a “next generation” innovative approach to developing biosimilars as it continues to bolster its pipeline, HoUng Kim, head of Celltrion Healthcare’s medical and marketing division, tells Generics Bulletin in an exclusive interview. But the firm sees the US interchangeability designation as an “unnecessary” regulatory barrier.
AbbVie delayed biosimilar competition to Humira “for far longer than warranted” and may have “engaged in other anti-competitive conduct to maintain its market share and pricing power” for the adalimumab brand, according to members of the US House of Representatives’ committee on oversight and reform. The US Federal Trade Commission has been urged to open a formal inquiry into the originator’s conduct.
While Celltrion has delivered an unimpressive first quarter of 2021, the company has pointed to plans to launch high-margin products in new markets. The Korean firm said that it was looking to launch its subcutaneous Remsima SC infliximab formulation in Canada and Australia in 2021, while it is also aiming to launch its Yuflyma (adalimumab) in more than 70% of the EU adalimumab market.