A combination of factors – including recent moves in the UK to broaden access to biosimilars for rheumatoid arthritis patients, as well as the new MHRA pathway for biosimilars and a growing call for global regulatory alignment – are contributing to a “biosimilar Zeitgeist” that could see long-in-the-making change coming for the industry, according to Sandoz CEO Richard Saynor.

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.

Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation. It has been warmly welcomed by the off-patent industry both locally and internationally.