Hetero Set To Join Indian Humira Biosimilar Line-Up
Hetero’s biosimilar version of AbbVie's Humira (adalimumab) appears on course to a debut in India and is set to follow peers like Zydus Cadila and Torrent, signaling the build-up of more competition for the blockbuster biologic across markets.
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Presenting equivalence data at EULAR for its biosimilar version of the world's best-selling drug, Humira, Boehringer Ingelheim is optimistic about its position in a crowded field. Karsten Kissel, head of global medical affairs biosimilars for the German group, spoke to Scrip.
India plans pivotal tweaks to its three-layered review process for clinical trial-related clearances – a move that is expected to pare approval timelines significantly and improve predictability for sponsors who have been generally cautious, over the recent past, about placing studies in the country.
Amgen’s biosimilar version of the anti-TNF adalimumab has become the first to receive an EU positive opinion but the company has no plans to launch the product this year.