Alvotech Differentiation Plans Include Interchangeable Golimumab

Icelandic Company Details Strategy Amid Proposed SPAC Merger

A proposal to merge with a special purpose acquisition company, in a move that will deliver longstanding plans for a public listing, has led biosimilars specialist Alvotech to discuss its ambitions and goals for its pipeline of seven biosimilar candidates.

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Alvotech anticipates more than $400m of fresh capital under the merger • Source: Alamy

Amid its proposed merger with a blank check company that would enable it to trade its shares publicly on one of the US’s largest stock exchanges, Alvotech has disclosed previously safeguarded strategic and financial goals, underpinned by the firm’s desire to differentiate from its competitors in order to be “the world’s leading biosimilars company.”

Alongside targeting potential in-licensing opportunities – after Alvogen’s biosimilars sister company struck historically a multitude of commercialization deals across the...

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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