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US FDA Outlines Biosimilar First Interchangeability Policy … In A Memo

 
• By Derrick Gingery

Stakeholders may be irked that the agency chose to release a memo on its interpretation of the first interchangeable exclusivity law before issuing formal guidance.

Humira 40mg
The memo on Humira biosimilars reveals some interchangeable exclusivity policies but there is more unpacking to do • Source: Shutterstock

Releasing a memo on a specific case may not be the most effective way to inform industry, but the US Food and Drug Administration’s views on first interchangeable exclusivity are finally available in its resolution of the issue for Boehringer Ingelheim GmbH’s Cyltezo, a biosimilar of AbbVie Inc.’s Humira.

The 18-page memo is only intended to apply to the situation involving Cyltezo and Pfizer Inc.’s Abrilada, a...

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Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By Dean Rudge

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
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Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

 
• By Urtė Fultinavičiūtė

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Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
• By Dave Wallace

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Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

 
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Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
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Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.