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Hetero Set To Join Indian Humira Biosimilar Line-Up

Executive Summary

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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AbbVie may have managed to push back direct biosimilar competition to Humira (adalimumab) in the US by a few years, but 2018 has begun with the launch of yet another biosimilar of the blockbuster biologic in India. Hetero, the latest entrant, expects to maintain pricing parity with its peers on the domestic market.

New Year Debut Of Another Biosimilar Humira In India

AbbVie may have managed to push back direct biosimilar competition to Humira (adalimumab) in the US by a few years, but 2018 has begun with the launch of yet another biosimilar of the blockbuster biologic in India. Hetero, the latest entrant, expects to maintain pricing parity with its peers on the domestic market.

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In a recent FDA warning letter to Hetero Labs in Hyderabad, India, investigators chastise the firm for lax GMP practices. Hetero joins a growing number of manufacturers in the city that have been targeted by FDA and EU regulators for GMP violations this year.

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